Description: About Us: Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (CTI-1601), is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich's ataxia. Friedreich's ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality. We have assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience. Our management team, employees, and consultants have significant expertise in discovery, non-clinical and clinical development, regulatory affairs, manufacturing and CMC. Our company's strategy is to become a leader in the treatment of rare diseases by leveraging our cell-penetrating technology platform and applying our team's know-how to the development of Nomlabofusp and our pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success. If you are searching for a company where urgency, agility, and commitment to science win the day - we welcome you! Position Summary: Larimar is seeking a CMC Regulatory Affairs Director to provide professional experience and leadership supporting the global CMC regulatory strategy and regulatory activities to bring products in development through global marketing authorization approval and launch. The Regulatory Affairs Director will be a key member of project teams and the role reports to the Regulatory Affairs Senior Director. Job Duties/Responsibilities: Larimar Team Membership The Director of CMC Regulatory Affairs will be a key member of the regulatory, clinical project, and technical operations (cross-functional) teams who will manage CMC regulatory aspects of projects related to global clinical trials, global health authority interactions and global marketing submissions and approvals. This person will work independently, and as a member of a team. Liaise internally with other members of the Regulatory Affairs department to coordinate the timely submission of CMC amendments, discuss suitable CMC strategies, evaluate global guidances, all to support the development programs of Larimar. Works closely with RA Sr. Director and serve as backup to other global regulatory activities Strategy, Guidance Responsible for defining, developing and executing global CMC regulatory strategies based on knowledge of guidelines with practical experience (previous IND, CTA, NDA, BLA filings) to successfully achieve objectives for complex Larimar projects Provides detailed and forward-looking tactical advice to technical teams and stakeholders to achieve timely and efficient program submissions and approval, while ensuring compliance with applicable global regulatory requirements Evaluates proposed manufacturing and quality changes for impact to current Health Authority Applications (INDs, CTAs) and provides strategic regulatory guidance for optimal implementation of changes. CMC Documentation, Submissions and HA interactions Develops and manages the content plans for global M3 CMC submissions or responses; coordinates document authoring (new or update), document review, and finalization of high-quality, style-guide compliant CMC documents that align with Larimar's regulatory submission timing and strategy With Larimar organization, manages the CMC portion of Larimar cross-functions team activity in preparation of meetings with global health authorities to define meeting objectives, development of meeting questions, execute the completion of the meeting package content and ultimate receipt of clear, specific and actional HA feedback based on the objectives of each meeting. Requirements: Key Experience, Skills and Knowledge: Minimum of 4-year undergraduate degree 10+ years' experience in a Regulatory Affairs role in the pharmaceutical industry, experience with Health Canada, EMA, MHRA and other local European agencies preferred Understanding of GxP systems and Quality principles Ability to research global regulatory guidance (nonclinical, clinical and CMC) and precedence to assist in the development and execution of global regulatory strategies. Knowledge of eCTD structure, components and basic regulatory operations which support in-house regulatory submissions Experience with preparation (authoring and review) of high-quality regulatory documents for global Health Authority submissions including but not limited to IND amendments, CTA submissions, Global Health Authority Meeting packages and Global marketing authorization applications. Excellent communication, time management and project management skills Continuous quality improvement mindset and attention to details Ability and willingness to work onsite, while maintaining strong collaboration in a hybrid work model. Can do attitude, flexibility, and mental agility Benefits: Larimar Therapeutics offers all employees a competitive salary with frequent market benchmarking, incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy. We are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner. We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live. Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and business needs. The decisions and criteria governing the relationship with all candidates and employees are made in a non-discriminatory manner-without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes. PI692d12ae19f9-7779
12/14/2025
Full time
Description: About Us: Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (CTI-1601), is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich's ataxia. Friedreich's ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality. We have assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience. Our management team, employees, and consultants have significant expertise in discovery, non-clinical and clinical development, regulatory affairs, manufacturing and CMC. Our company's strategy is to become a leader in the treatment of rare diseases by leveraging our cell-penetrating technology platform and applying our team's know-how to the development of Nomlabofusp and our pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success. If you are searching for a company where urgency, agility, and commitment to science win the day - we welcome you! Position Summary: Larimar is seeking a CMC Regulatory Affairs Director to provide professional experience and leadership supporting the global CMC regulatory strategy and regulatory activities to bring products in development through global marketing authorization approval and launch. The Regulatory Affairs Director will be a key member of project teams and the role reports to the Regulatory Affairs Senior Director. Job Duties/Responsibilities: Larimar Team Membership The Director of CMC Regulatory Affairs will be a key member of the regulatory, clinical project, and technical operations (cross-functional) teams who will manage CMC regulatory aspects of projects related to global clinical trials, global health authority interactions and global marketing submissions and approvals. This person will work independently, and as a member of a team. Liaise internally with other members of the Regulatory Affairs department to coordinate the timely submission of CMC amendments, discuss suitable CMC strategies, evaluate global guidances, all to support the development programs of Larimar. Works closely with RA Sr. Director and serve as backup to other global regulatory activities Strategy, Guidance Responsible for defining, developing and executing global CMC regulatory strategies based on knowledge of guidelines with practical experience (previous IND, CTA, NDA, BLA filings) to successfully achieve objectives for complex Larimar projects Provides detailed and forward-looking tactical advice to technical teams and stakeholders to achieve timely and efficient program submissions and approval, while ensuring compliance with applicable global regulatory requirements Evaluates proposed manufacturing and quality changes for impact to current Health Authority Applications (INDs, CTAs) and provides strategic regulatory guidance for optimal implementation of changes. CMC Documentation, Submissions and HA interactions Develops and manages the content plans for global M3 CMC submissions or responses; coordinates document authoring (new or update), document review, and finalization of high-quality, style-guide compliant CMC documents that align with Larimar's regulatory submission timing and strategy With Larimar organization, manages the CMC portion of Larimar cross-functions team activity in preparation of meetings with global health authorities to define meeting objectives, development of meeting questions, execute the completion of the meeting package content and ultimate receipt of clear, specific and actional HA feedback based on the objectives of each meeting. Requirements: Key Experience, Skills and Knowledge: Minimum of 4-year undergraduate degree 10+ years' experience in a Regulatory Affairs role in the pharmaceutical industry, experience with Health Canada, EMA, MHRA and other local European agencies preferred Understanding of GxP systems and Quality principles Ability to research global regulatory guidance (nonclinical, clinical and CMC) and precedence to assist in the development and execution of global regulatory strategies. Knowledge of eCTD structure, components and basic regulatory operations which support in-house regulatory submissions Experience with preparation (authoring and review) of high-quality regulatory documents for global Health Authority submissions including but not limited to IND amendments, CTA submissions, Global Health Authority Meeting packages and Global marketing authorization applications. Excellent communication, time management and project management skills Continuous quality improvement mindset and attention to details Ability and willingness to work onsite, while maintaining strong collaboration in a hybrid work model. Can do attitude, flexibility, and mental agility Benefits: Larimar Therapeutics offers all employees a competitive salary with frequent market benchmarking, incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy. We are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner. We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live. Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and business needs. The decisions and criteria governing the relationship with all candidates and employees are made in a non-discriminatory manner-without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes. PI692d12ae19f9-7779
ROLE SUMMARY Today, Pfizer Oncology has an industry-leading portfolio of 25 approved innovative cancer medicines, including major therapies for metastatic breast cancer, prostate cancer, urothelial carcinoma, and hematologic malignancies. Pfizer's in-line portfolio is focused on four broad, key areas: breast cancer, genitourinary cancer, hematology, and precision medicine, complemented by an extensive pipeline of over 50 programs in clinical development. The Oncology Scientific Communications Director will report to the Team Lead within Pfizer Oncology Medical Strategy Management The Oncology Scientific Communications Director will lead the development and execution of impactful scientific communication strategies for assigned Pfizer medicines and across their tumor area, with a focus on achieving a singular scientific voice anchored to the evidence. The Director will ensure that overall scientific communication and content strategies reflect TA priorities and that tactical execution of medical and scientific communication activities, specifically focused on optimizing the engagement and reach of emerging scientific information within the oncology community, occurs successfully and according to strategy. This role will focus on achieving a singular scientific voice anchored to the evidence, optimizing the engagement, consistency and reach of emerging scientific information within the oncology community. They will be a subject matter expert in one of the three below chosen capabilities: Therapeutic Area (TA) Scientific Communications: ensure asset strategies and messaging are seamlessly integrated into TA-specific plans and materials. The TA Sci Comms lead will also focus on the delivery of foundational resources such as Scientific Communications Platforms (SCPs), Narratives, and FAQs. Data Disclosure (Publications): Collaborate with TA teams and Sci Comms colleagues to drive the publication planning, writing, and dissemination of scientific data from clinical trials and research activities, ensuring a cohesive and impactful publication strategy across the portfolio. Medical Content: Create a wide range of engaging and informative scientific content for diverse channels and audiences, including medical to medical resources, congress and digital platform content. ROLES AND RESPONSIBILITIES The Director will be responsible for the following, with specific responsibilities varying based on the chosen Sci Comms functional focus area (TA, Data Disclosures, or Content). This role may require working across two functional areas for one product/program. General Responsibilities (applicable to all focus areas): Responsible for ensuring strategic input from a broad range of stakeholders (internal and external) is integrated into scientific communications strategic planning to meet the needs of these stakeholders and especially the Oncology Medical TA teams Support Global Product Teams, Global Medical franchises, and other Pfizer Oncology stakeholders in engaging with the external medical community on activities related to key clinical trial data readouts. Ensure alignment of each product's overall scientific content/communications strategy with relevant Pfizer Oncology stakeholders (e.g., partnering with cross-functional Medical Teams, Channel Excellence, Data Analytics, and other key stakeholders to ensure alignment of communication plans with medical priorities and optimize opportunities for broader data dissemination) Act as a strategic thought partner to the TA medical team, providing sci comms functional guidance and subject matter expertise in their designated focus area Leads financial projections and budget management for functional deliverables in addition to managing agencies and off-shore teams (if applicable) Collaborate with International Medical Channel Content team to ensure sci comms deliverables are shared with country medical colleagues for adaptation Have a thorough understanding of therapeutic area assigned, including policy related issues, and the individual inline and pipeline assets across the specific TAs with an ability either to serve as a primary point of contact for accurate, current medical and scientific knowledge or to identify the appropriate Subject Matter Expert within therapeutic area, for internal and external stakeholders and customers. Responsible for building collaborative relationships with relevant partners in and outside of Medical to ensure optimal creation and execution of channel-specific TA medical communications strategies. Stay abreast of US regulations and guidance that impact digital delivery of scientific information to external HCPs TA Communications: Accountable for strategic oversight of TA scientific communication activities and the overarching scientific communications objectives/strategy/narrative, ensuring alignment and excellence in delivery As a core member of the Global Medical Affairs Team (GMAT), responsible for identifying the need for and establishing the Scientific Communications Platform (SCP) for TA products early in development based on target profile, clinical evidence, disease state/landscape, and aspirational label. For later life-cycle assets, determine the need for and enrich the SCP (based on wide cross-functional input) with evolving evidence from clinical studies, insights, the Clinical Development Plan and regulatory strategy to ensure teams use accurate, consistent language Ensure the product-level SCP is aligned to the broader Therapeutic Area, tumor and/or modality scientific narrative and that information is pulled through to all scientific communication deliverables Establish and maintain the Scientific Communication Platform (SCP) for products in their TA, including overarching scientific communication objectives. In addition to Therapeutic Area and Asset-specific SCPs, the TA Sci Comms lead is responsible for developing global medical narratives and FAQs around key data disclosures Work closely with clinical/medical teams during data readouts to determine key messages (aligned to the SCP) Collaborate with non-Medical stakeholders (e.g. Scientific Affairs, Corporate Communication, etc.) to ensure consistency of scientific communications for non-medical audiences. Orchestrate OLT (Oncology Leadership Team) informs/reviews of key disclosures. Co-chair medical/sci-comms sub-committee(s) of the GMAT Data Disclosure (Publications): Focus: Drive and deliver on data disclosure plans, including Plain Language Summaries (PLS) and Enhanced Publication Content (EPC) Manage author reviews and preparedness Chair Scientific Publications Committees (SPCs) Work closely with clinical study teams during data readouts to determine publication content Ensure updates to global publication plans occur as needed on a regular basis Support GPTs, Global Medical franchises, and other Pfizer Oncology stakeholders by engaging with the external medical community on publication activities. Serve as a core member of medical/sci-comms sub-committee(s) of the GMAT. Content Focus: Lead above or specific-therapeutic area content strategies, projects, digital initiatives and broad enterprise-wide initiatives to advance content impact throughout the organization across all medical content on externally- and internally-facing medical channels Define and deliver external Global and US medical-to-medical content for Field/HQ/Congresses; congress content, digital medical platforms, and content for newly prioritized medical channels. Ensure updates to global congress content occurs as needed on a regular basis in coordination with key cross-functional stakeholders, including commercial, development and Medical TA teams and platforms. Responsible for ensuring the creation of field medical content is aligned with the needs of the Pfizer Oncology Global Medical TA team and regional/local Medical Affairs. Proactively resolve issues around content creation, combining medical affairs expertise with an understanding of the patient, healthcare professional, legal, regulatory, and organized customer points of view. Define and deliver TA training content with support from Platform training teams when applicable. Serve as a core member of medical/sci-comms sub-committee(s) of the GMAT. Note: while colleagues will typically focus on one of these areas, there is an expectation that if a business need arises, the team member can adapt and support other functional focus areas. QUALIFICATIONS Bachelor's degree with a minimum of 10 years of relevant biopharmaceutical/biotech or agency experience (such as Medical Communications, Medical Affairs or scientific communications within Clinical Development roles). Advanced scientific degree (PhD, PharmD, MS, etc.) preferred Experience developing strategic scientific communications and other scientific content to support scientific exchange, including the use of tools and programs to meet the needs of HCPs. Have a strong understanding of Medical Affairs, including medical strategies, disease areas, and objectives. Ability to quickly build rapport and credibility with key internal and key external stakeholders through strong interpersonal skills; strong matrix leadership Demonstrated ability to translate complex scientific concepts and data into meaningful and digestible communications and foundational tools that can be utilized via multiple channels including at scientific conferences click apply for full job details
12/13/2025
Full time
ROLE SUMMARY Today, Pfizer Oncology has an industry-leading portfolio of 25 approved innovative cancer medicines, including major therapies for metastatic breast cancer, prostate cancer, urothelial carcinoma, and hematologic malignancies. Pfizer's in-line portfolio is focused on four broad, key areas: breast cancer, genitourinary cancer, hematology, and precision medicine, complemented by an extensive pipeline of over 50 programs in clinical development. The Oncology Scientific Communications Director will report to the Team Lead within Pfizer Oncology Medical Strategy Management The Oncology Scientific Communications Director will lead the development and execution of impactful scientific communication strategies for assigned Pfizer medicines and across their tumor area, with a focus on achieving a singular scientific voice anchored to the evidence. The Director will ensure that overall scientific communication and content strategies reflect TA priorities and that tactical execution of medical and scientific communication activities, specifically focused on optimizing the engagement and reach of emerging scientific information within the oncology community, occurs successfully and according to strategy. This role will focus on achieving a singular scientific voice anchored to the evidence, optimizing the engagement, consistency and reach of emerging scientific information within the oncology community. They will be a subject matter expert in one of the three below chosen capabilities: Therapeutic Area (TA) Scientific Communications: ensure asset strategies and messaging are seamlessly integrated into TA-specific plans and materials. The TA Sci Comms lead will also focus on the delivery of foundational resources such as Scientific Communications Platforms (SCPs), Narratives, and FAQs. Data Disclosure (Publications): Collaborate with TA teams and Sci Comms colleagues to drive the publication planning, writing, and dissemination of scientific data from clinical trials and research activities, ensuring a cohesive and impactful publication strategy across the portfolio. Medical Content: Create a wide range of engaging and informative scientific content for diverse channels and audiences, including medical to medical resources, congress and digital platform content. ROLES AND RESPONSIBILITIES The Director will be responsible for the following, with specific responsibilities varying based on the chosen Sci Comms functional focus area (TA, Data Disclosures, or Content). This role may require working across two functional areas for one product/program. General Responsibilities (applicable to all focus areas): Responsible for ensuring strategic input from a broad range of stakeholders (internal and external) is integrated into scientific communications strategic planning to meet the needs of these stakeholders and especially the Oncology Medical TA teams Support Global Product Teams, Global Medical franchises, and other Pfizer Oncology stakeholders in engaging with the external medical community on activities related to key clinical trial data readouts. Ensure alignment of each product's overall scientific content/communications strategy with relevant Pfizer Oncology stakeholders (e.g., partnering with cross-functional Medical Teams, Channel Excellence, Data Analytics, and other key stakeholders to ensure alignment of communication plans with medical priorities and optimize opportunities for broader data dissemination) Act as a strategic thought partner to the TA medical team, providing sci comms functional guidance and subject matter expertise in their designated focus area Leads financial projections and budget management for functional deliverables in addition to managing agencies and off-shore teams (if applicable) Collaborate with International Medical Channel Content team to ensure sci comms deliverables are shared with country medical colleagues for adaptation Have a thorough understanding of therapeutic area assigned, including policy related issues, and the individual inline and pipeline assets across the specific TAs with an ability either to serve as a primary point of contact for accurate, current medical and scientific knowledge or to identify the appropriate Subject Matter Expert within therapeutic area, for internal and external stakeholders and customers. Responsible for building collaborative relationships with relevant partners in and outside of Medical to ensure optimal creation and execution of channel-specific TA medical communications strategies. Stay abreast of US regulations and guidance that impact digital delivery of scientific information to external HCPs TA Communications: Accountable for strategic oversight of TA scientific communication activities and the overarching scientific communications objectives/strategy/narrative, ensuring alignment and excellence in delivery As a core member of the Global Medical Affairs Team (GMAT), responsible for identifying the need for and establishing the Scientific Communications Platform (SCP) for TA products early in development based on target profile, clinical evidence, disease state/landscape, and aspirational label. For later life-cycle assets, determine the need for and enrich the SCP (based on wide cross-functional input) with evolving evidence from clinical studies, insights, the Clinical Development Plan and regulatory strategy to ensure teams use accurate, consistent language Ensure the product-level SCP is aligned to the broader Therapeutic Area, tumor and/or modality scientific narrative and that information is pulled through to all scientific communication deliverables Establish and maintain the Scientific Communication Platform (SCP) for products in their TA, including overarching scientific communication objectives. In addition to Therapeutic Area and Asset-specific SCPs, the TA Sci Comms lead is responsible for developing global medical narratives and FAQs around key data disclosures Work closely with clinical/medical teams during data readouts to determine key messages (aligned to the SCP) Collaborate with non-Medical stakeholders (e.g. Scientific Affairs, Corporate Communication, etc.) to ensure consistency of scientific communications for non-medical audiences. Orchestrate OLT (Oncology Leadership Team) informs/reviews of key disclosures. Co-chair medical/sci-comms sub-committee(s) of the GMAT Data Disclosure (Publications): Focus: Drive and deliver on data disclosure plans, including Plain Language Summaries (PLS) and Enhanced Publication Content (EPC) Manage author reviews and preparedness Chair Scientific Publications Committees (SPCs) Work closely with clinical study teams during data readouts to determine publication content Ensure updates to global publication plans occur as needed on a regular basis Support GPTs, Global Medical franchises, and other Pfizer Oncology stakeholders by engaging with the external medical community on publication activities. Serve as a core member of medical/sci-comms sub-committee(s) of the GMAT. Content Focus: Lead above or specific-therapeutic area content strategies, projects, digital initiatives and broad enterprise-wide initiatives to advance content impact throughout the organization across all medical content on externally- and internally-facing medical channels Define and deliver external Global and US medical-to-medical content for Field/HQ/Congresses; congress content, digital medical platforms, and content for newly prioritized medical channels. Ensure updates to global congress content occurs as needed on a regular basis in coordination with key cross-functional stakeholders, including commercial, development and Medical TA teams and platforms. Responsible for ensuring the creation of field medical content is aligned with the needs of the Pfizer Oncology Global Medical TA team and regional/local Medical Affairs. Proactively resolve issues around content creation, combining medical affairs expertise with an understanding of the patient, healthcare professional, legal, regulatory, and organized customer points of view. Define and deliver TA training content with support from Platform training teams when applicable. Serve as a core member of medical/sci-comms sub-committee(s) of the GMAT. Note: while colleagues will typically focus on one of these areas, there is an expectation that if a business need arises, the team member can adapt and support other functional focus areas. QUALIFICATIONS Bachelor's degree with a minimum of 10 years of relevant biopharmaceutical/biotech or agency experience (such as Medical Communications, Medical Affairs or scientific communications within Clinical Development roles). Advanced scientific degree (PhD, PharmD, MS, etc.) preferred Experience developing strategic scientific communications and other scientific content to support scientific exchange, including the use of tools and programs to meet the needs of HCPs. Have a strong understanding of Medical Affairs, including medical strategies, disease areas, and objectives. Ability to quickly build rapport and credibility with key internal and key external stakeholders through strong interpersonal skills; strong matrix leadership Demonstrated ability to translate complex scientific concepts and data into meaningful and digestible communications and foundational tools that can be utilized via multiple channels including at scientific conferences click apply for full job details
ROLE SUMMARY Today, Pfizer Oncology has an industry-leading portfolio of 25 approved innovative cancer medicines, including major therapies for metastatic breast cancer, prostate cancer, urothelial carcinoma, and hematologic malignancies. Pfizer's in-line portfolio is focused on four broad, key areas: breast cancer, genitourinary cancer, hematology, and precision medicine, complemented by an extensive pipeline of over 50 programs in clinical development. The Oncology Scientific Communications Director will report to the Team Lead within Pfizer Oncology Medical Strategy Management The Oncology Scientific Communications Director will lead the development and execution of impactful scientific communication strategies for assigned Pfizer medicines and across their tumor area, with a focus on achieving a singular scientific voice anchored to the evidence. The Director will ensure that overall scientific communication and content strategies reflect TA priorities and that tactical execution of medical and scientific communication activities, specifically focused on optimizing the engagement and reach of emerging scientific information within the oncology community, occurs successfully and according to strategy. This role will focus on achieving a singular scientific voice anchored to the evidence, optimizing the engagement, consistency and reach of emerging scientific information within the oncology community. They will be a subject matter expert in one of the three below chosen capabilities: Therapeutic Area (TA) Scientific Communications: ensure asset strategies and messaging are seamlessly integrated into TA-specific plans and materials. The TA Sci Comms lead will also focus on the delivery of foundational resources such as Scientific Communications Platforms (SCPs), Narratives, and FAQs. Data Disclosure (Publications): Collaborate with TA teams and Sci Comms colleagues to drive the publication planning, writing, and dissemination of scientific data from clinical trials and research activities, ensuring a cohesive and impactful publication strategy across the portfolio. Medical Content: Create a wide range of engaging and informative scientific content for diverse channels and audiences, including medical to medical resources, congress and digital platform content. ROLES AND RESPONSIBILITIES The Director will be responsible for the following, with specific responsibilities varying based on the chosen Sci Comms functional focus area (TA, Data Disclosures, or Content). This role may require working across two functional areas for one product/program. General Responsibilities (applicable to all focus areas): Responsible for ensuring strategic input from a broad range of stakeholders (internal and external) is integrated into scientific communications strategic planning to meet the needs of these stakeholders and especially the Oncology Medical TA teams Support Global Product Teams, Global Medical franchises, and other Pfizer Oncology stakeholders in engaging with the external medical community on activities related to key clinical trial data readouts. Ensure alignment of each product's overall scientific content/communications strategy with relevant Pfizer Oncology stakeholders (e.g., partnering with cross-functional Medical Teams, Channel Excellence, Data Analytics, and other key stakeholders to ensure alignment of communication plans with medical priorities and optimize opportunities for broader data dissemination) Act as a strategic thought partner to the TA medical team, providing sci comms functional guidance and subject matter expertise in their designated focus area Leads financial projections and budget management for functional deliverables in addition to managing agencies and off-shore teams (if applicable) Collaborate with International Medical Channel Content team to ensure sci comms deliverables are shared with country medical colleagues for adaptation Have a thorough understanding of therapeutic area assigned, including policy related issues, and the individual inline and pipeline assets across the specific TAs with an ability either to serve as a primary point of contact for accurate, current medical and scientific knowledge or to identify the appropriate Subject Matter Expert within therapeutic area, for internal and external stakeholders and customers. Responsible for building collaborative relationships with relevant partners in and outside of Medical to ensure optimal creation and execution of channel-specific TA medical communications strategies. Stay abreast of US regulations and guidance that impact digital delivery of scientific information to external HCPs TA Communications: Accountable for strategic oversight of TA scientific communication activities and the overarching scientific communications objectives/strategy/narrative, ensuring alignment and excellence in delivery As a core member of the Global Medical Affairs Team (GMAT), responsible for identifying the need for and establishing the Scientific Communications Platform (SCP) for TA products early in development based on target profile, clinical evidence, disease state/landscape, and aspirational label. For later life-cycle assets, determine the need for and enrich the SCP (based on wide cross-functional input) with evolving evidence from clinical studies, insights, the Clinical Development Plan and regulatory strategy to ensure teams use accurate, consistent language Ensure the product-level SCP is aligned to the broader Therapeutic Area, tumor and/or modality scientific narrative and that information is pulled through to all scientific communication deliverables Establish and maintain the Scientific Communication Platform (SCP) for products in their TA, including overarching scientific communication objectives. In addition to Therapeutic Area and Asset-specific SCPs, the TA Sci Comms lead is responsible for developing global medical narratives and FAQs around key data disclosures Work closely with clinical/medical teams during data readouts to determine key messages (aligned to the SCP) Collaborate with non-Medical stakeholders (e.g. Scientific Affairs, Corporate Communication, etc.) to ensure consistency of scientific communications for non-medical audiences. Orchestrate OLT (Oncology Leadership Team) informs/reviews of key disclosures. Co-chair medical/sci-comms sub-committee(s) of the GMAT Data Disclosure (Publications): Focus: Drive and deliver on data disclosure plans, including Plain Language Summaries (PLS) and Enhanced Publication Content (EPC) Manage author reviews and preparedness Chair Scientific Publications Committees (SPCs) Work closely with clinical study teams during data readouts to determine publication content Ensure updates to global publication plans occur as needed on a regular basis Support GPTs, Global Medical franchises, and other Pfizer Oncology stakeholders by engaging with the external medical community on publication activities. Serve as a core member of medical/sci-comms sub-committee(s) of the GMAT. Content Focus: Lead above or specific-therapeutic area content strategies, projects, digital initiatives and broad enterprise-wide initiatives to advance content impact throughout the organization across all medical content on externally- and internally-facing medical channels Define and deliver external Global and US medical-to-medical content for Field/HQ/Congresses; congress content, digital medical platforms, and content for newly prioritized medical channels. Ensure updates to global congress content occurs as needed on a regular basis in coordination with key cross-functional stakeholders, including commercial, development and Medical TA teams and platforms. Responsible for ensuring the creation of field medical content is aligned with the needs of the Pfizer Oncology Global Medical TA team and regional/local Medical Affairs. Proactively resolve issues around content creation, combining medical affairs expertise with an understanding of the patient, healthcare professional, legal, regulatory, and organized customer points of view. Define and deliver TA training content with support from Platform training teams when applicable. Serve as a core member of medical/sci-comms sub-committee(s) of the GMAT. Note: while colleagues will typically focus on one of these areas, there is an expectation that if a business need arises, the team member can adapt and support other functional focus areas. QUALIFICATIONS Bachelor's degree with a minimum of 10 years of relevant biopharmaceutical/biotech or agency experience (such as Medical Communications, Medical Affairs or scientific communications within Clinical Development roles). Advanced scientific degree (PhD, PharmD, MS, etc.) preferred Experience developing strategic scientific communications and other scientific content to support scientific exchange, including the use of tools and programs to meet the needs of HCPs. Have a strong understanding of Medical Affairs, including medical strategies, disease areas, and objectives. Ability to quickly build rapport and credibility with key internal and key external stakeholders through strong interpersonal skills; strong matrix leadership Demonstrated ability to translate complex scientific concepts and data into meaningful and digestible communications and foundational tools that can be utilized via multiple channels including at scientific conferences click apply for full job details
12/13/2025
Full time
ROLE SUMMARY Today, Pfizer Oncology has an industry-leading portfolio of 25 approved innovative cancer medicines, including major therapies for metastatic breast cancer, prostate cancer, urothelial carcinoma, and hematologic malignancies. Pfizer's in-line portfolio is focused on four broad, key areas: breast cancer, genitourinary cancer, hematology, and precision medicine, complemented by an extensive pipeline of over 50 programs in clinical development. The Oncology Scientific Communications Director will report to the Team Lead within Pfizer Oncology Medical Strategy Management The Oncology Scientific Communications Director will lead the development and execution of impactful scientific communication strategies for assigned Pfizer medicines and across their tumor area, with a focus on achieving a singular scientific voice anchored to the evidence. The Director will ensure that overall scientific communication and content strategies reflect TA priorities and that tactical execution of medical and scientific communication activities, specifically focused on optimizing the engagement and reach of emerging scientific information within the oncology community, occurs successfully and according to strategy. This role will focus on achieving a singular scientific voice anchored to the evidence, optimizing the engagement, consistency and reach of emerging scientific information within the oncology community. They will be a subject matter expert in one of the three below chosen capabilities: Therapeutic Area (TA) Scientific Communications: ensure asset strategies and messaging are seamlessly integrated into TA-specific plans and materials. The TA Sci Comms lead will also focus on the delivery of foundational resources such as Scientific Communications Platforms (SCPs), Narratives, and FAQs. Data Disclosure (Publications): Collaborate with TA teams and Sci Comms colleagues to drive the publication planning, writing, and dissemination of scientific data from clinical trials and research activities, ensuring a cohesive and impactful publication strategy across the portfolio. Medical Content: Create a wide range of engaging and informative scientific content for diverse channels and audiences, including medical to medical resources, congress and digital platform content. ROLES AND RESPONSIBILITIES The Director will be responsible for the following, with specific responsibilities varying based on the chosen Sci Comms functional focus area (TA, Data Disclosures, or Content). This role may require working across two functional areas for one product/program. General Responsibilities (applicable to all focus areas): Responsible for ensuring strategic input from a broad range of stakeholders (internal and external) is integrated into scientific communications strategic planning to meet the needs of these stakeholders and especially the Oncology Medical TA teams Support Global Product Teams, Global Medical franchises, and other Pfizer Oncology stakeholders in engaging with the external medical community on activities related to key clinical trial data readouts. Ensure alignment of each product's overall scientific content/communications strategy with relevant Pfizer Oncology stakeholders (e.g., partnering with cross-functional Medical Teams, Channel Excellence, Data Analytics, and other key stakeholders to ensure alignment of communication plans with medical priorities and optimize opportunities for broader data dissemination) Act as a strategic thought partner to the TA medical team, providing sci comms functional guidance and subject matter expertise in their designated focus area Leads financial projections and budget management for functional deliverables in addition to managing agencies and off-shore teams (if applicable) Collaborate with International Medical Channel Content team to ensure sci comms deliverables are shared with country medical colleagues for adaptation Have a thorough understanding of therapeutic area assigned, including policy related issues, and the individual inline and pipeline assets across the specific TAs with an ability either to serve as a primary point of contact for accurate, current medical and scientific knowledge or to identify the appropriate Subject Matter Expert within therapeutic area, for internal and external stakeholders and customers. Responsible for building collaborative relationships with relevant partners in and outside of Medical to ensure optimal creation and execution of channel-specific TA medical communications strategies. Stay abreast of US regulations and guidance that impact digital delivery of scientific information to external HCPs TA Communications: Accountable for strategic oversight of TA scientific communication activities and the overarching scientific communications objectives/strategy/narrative, ensuring alignment and excellence in delivery As a core member of the Global Medical Affairs Team (GMAT), responsible for identifying the need for and establishing the Scientific Communications Platform (SCP) for TA products early in development based on target profile, clinical evidence, disease state/landscape, and aspirational label. For later life-cycle assets, determine the need for and enrich the SCP (based on wide cross-functional input) with evolving evidence from clinical studies, insights, the Clinical Development Plan and regulatory strategy to ensure teams use accurate, consistent language Ensure the product-level SCP is aligned to the broader Therapeutic Area, tumor and/or modality scientific narrative and that information is pulled through to all scientific communication deliverables Establish and maintain the Scientific Communication Platform (SCP) for products in their TA, including overarching scientific communication objectives. In addition to Therapeutic Area and Asset-specific SCPs, the TA Sci Comms lead is responsible for developing global medical narratives and FAQs around key data disclosures Work closely with clinical/medical teams during data readouts to determine key messages (aligned to the SCP) Collaborate with non-Medical stakeholders (e.g. Scientific Affairs, Corporate Communication, etc.) to ensure consistency of scientific communications for non-medical audiences. Orchestrate OLT (Oncology Leadership Team) informs/reviews of key disclosures. Co-chair medical/sci-comms sub-committee(s) of the GMAT Data Disclosure (Publications): Focus: Drive and deliver on data disclosure plans, including Plain Language Summaries (PLS) and Enhanced Publication Content (EPC) Manage author reviews and preparedness Chair Scientific Publications Committees (SPCs) Work closely with clinical study teams during data readouts to determine publication content Ensure updates to global publication plans occur as needed on a regular basis Support GPTs, Global Medical franchises, and other Pfizer Oncology stakeholders by engaging with the external medical community on publication activities. Serve as a core member of medical/sci-comms sub-committee(s) of the GMAT. Content Focus: Lead above or specific-therapeutic area content strategies, projects, digital initiatives and broad enterprise-wide initiatives to advance content impact throughout the organization across all medical content on externally- and internally-facing medical channels Define and deliver external Global and US medical-to-medical content for Field/HQ/Congresses; congress content, digital medical platforms, and content for newly prioritized medical channels. Ensure updates to global congress content occurs as needed on a regular basis in coordination with key cross-functional stakeholders, including commercial, development and Medical TA teams and platforms. Responsible for ensuring the creation of field medical content is aligned with the needs of the Pfizer Oncology Global Medical TA team and regional/local Medical Affairs. Proactively resolve issues around content creation, combining medical affairs expertise with an understanding of the patient, healthcare professional, legal, regulatory, and organized customer points of view. Define and deliver TA training content with support from Platform training teams when applicable. Serve as a core member of medical/sci-comms sub-committee(s) of the GMAT. Note: while colleagues will typically focus on one of these areas, there is an expectation that if a business need arises, the team member can adapt and support other functional focus areas. QUALIFICATIONS Bachelor's degree with a minimum of 10 years of relevant biopharmaceutical/biotech or agency experience (such as Medical Communications, Medical Affairs or scientific communications within Clinical Development roles). Advanced scientific degree (PhD, PharmD, MS, etc.) preferred Experience developing strategic scientific communications and other scientific content to support scientific exchange, including the use of tools and programs to meet the needs of HCPs. Have a strong understanding of Medical Affairs, including medical strategies, disease areas, and objectives. Ability to quickly build rapport and credibility with key internal and key external stakeholders through strong interpersonal skills; strong matrix leadership Demonstrated ability to translate complex scientific concepts and data into meaningful and digestible communications and foundational tools that can be utilized via multiple channels including at scientific conferences click apply for full job details
ROLE SUMMARY Today, Pfizer Oncology has an industry-leading portfolio of 25 approved innovative cancer medicines, including major therapies for metastatic breast cancer, prostate cancer, urothelial carcinoma, and hematologic malignancies. Pfizer's in-line portfolio is focused on four broad, key areas: breast cancer, genitourinary cancer, hematology, and precision medicine, complemented by an extensive pipeline of over 50 programs in clinical development. The Oncology Scientific Communications Director will report to the Team Lead within Pfizer Oncology Medical Strategy Management The Oncology Scientific Communications Director will lead the development and execution of impactful scientific communication strategies for assigned Pfizer medicines and across their tumor area, with a focus on achieving a singular scientific voice anchored to the evidence. The Director will ensure that overall scientific communication and content strategies reflect TA priorities and that tactical execution of medical and scientific communication activities, specifically focused on optimizing the engagement and reach of emerging scientific information within the oncology community, occurs successfully and according to strategy. This role will focus on achieving a singular scientific voice anchored to the evidence, optimizing the engagement, consistency and reach of emerging scientific information within the oncology community. They will be a subject matter expert in one of the three below chosen capabilities: Therapeutic Area (TA) Scientific Communications: ensure asset strategies and messaging are seamlessly integrated into TA-specific plans and materials. The TA Sci Comms lead will also focus on the delivery of foundational resources such as Scientific Communications Platforms (SCPs), Narratives, and FAQs. Data Disclosure (Publications): Collaborate with TA teams and Sci Comms colleagues to drive the publication planning, writing, and dissemination of scientific data from clinical trials and research activities, ensuring a cohesive and impactful publication strategy across the portfolio. Medical Content: Create a wide range of engaging and informative scientific content for diverse channels and audiences, including medical to medical resources, congress and digital platform content. ROLES AND RESPONSIBILITIES The Director will be responsible for the following, with specific responsibilities varying based on the chosen Sci Comms functional focus area (TA, Data Disclosures, or Content). This role may require working across two functional areas for one product/program. General Responsibilities (applicable to all focus areas): Responsible for ensuring strategic input from a broad range of stakeholders (internal and external) is integrated into scientific communications strategic planning to meet the needs of these stakeholders and especially the Oncology Medical TA teams Support Global Product Teams, Global Medical franchises, and other Pfizer Oncology stakeholders in engaging with the external medical community on activities related to key clinical trial data readouts. Ensure alignment of each product's overall scientific content/communications strategy with relevant Pfizer Oncology stakeholders (e.g., partnering with cross-functional Medical Teams, Channel Excellence, Data Analytics, and other key stakeholders to ensure alignment of communication plans with medical priorities and optimize opportunities for broader data dissemination) Act as a strategic thought partner to the TA medical team, providing sci comms functional guidance and subject matter expertise in their designated focus area Leads financial projections and budget management for functional deliverables in addition to managing agencies and off-shore teams (if applicable) Collaborate with International Medical Channel Content team to ensure sci comms deliverables are shared with country medical colleagues for adaptation Have a thorough understanding of therapeutic area assigned, including policy related issues, and the individual inline and pipeline assets across the specific TAs with an ability either to serve as a primary point of contact for accurate, current medical and scientific knowledge or to identify the appropriate Subject Matter Expert within therapeutic area, for internal and external stakeholders and customers. Responsible for building collaborative relationships with relevant partners in and outside of Medical to ensure optimal creation and execution of channel-specific TA medical communications strategies. Stay abreast of US regulations and guidance that impact digital delivery of scientific information to external HCPs TA Communications: Accountable for strategic oversight of TA scientific communication activities and the overarching scientific communications objectives/strategy/narrative, ensuring alignment and excellence in delivery As a core member of the Global Medical Affairs Team (GMAT), responsible for identifying the need for and establishing the Scientific Communications Platform (SCP) for TA products early in development based on target profile, clinical evidence, disease state/landscape, and aspirational label. For later life-cycle assets, determine the need for and enrich the SCP (based on wide cross-functional input) with evolving evidence from clinical studies, insights, the Clinical Development Plan and regulatory strategy to ensure teams use accurate, consistent language Ensure the product-level SCP is aligned to the broader Therapeutic Area, tumor and/or modality scientific narrative and that information is pulled through to all scientific communication deliverables Establish and maintain the Scientific Communication Platform (SCP) for products in their TA, including overarching scientific communication objectives. In addition to Therapeutic Area and Asset-specific SCPs, the TA Sci Comms lead is responsible for developing global medical narratives and FAQs around key data disclosures Work closely with clinical/medical teams during data readouts to determine key messages (aligned to the SCP) Collaborate with non-Medical stakeholders (e.g. Scientific Affairs, Corporate Communication, etc.) to ensure consistency of scientific communications for non-medical audiences. Orchestrate OLT (Oncology Leadership Team) informs/reviews of key disclosures. Co-chair medical/sci-comms sub-committee(s) of the GMAT Data Disclosure (Publications): Focus: Drive and deliver on data disclosure plans, including Plain Language Summaries (PLS) and Enhanced Publication Content (EPC) Manage author reviews and preparedness Chair Scientific Publications Committees (SPCs) Work closely with clinical study teams during data readouts to determine publication content Ensure updates to global publication plans occur as needed on a regular basis Support GPTs, Global Medical franchises, and other Pfizer Oncology stakeholders by engaging with the external medical community on publication activities. Serve as a core member of medical/sci-comms sub-committee(s) of the GMAT. Content Focus: Lead above or specific-therapeutic area content strategies, projects, digital initiatives and broad enterprise-wide initiatives to advance content impact throughout the organization across all medical content on externally- and internally-facing medical channels Define and deliver external Global and US medical-to-medical content for Field/HQ/Congresses; congress content, digital medical platforms, and content for newly prioritized medical channels. Ensure updates to global congress content occurs as needed on a regular basis in coordination with key cross-functional stakeholders, including commercial, development and Medical TA teams and platforms. Responsible for ensuring the creation of field medical content is aligned with the needs of the Pfizer Oncology Global Medical TA team and regional/local Medical Affairs. Proactively resolve issues around content creation, combining medical affairs expertise with an understanding of the patient, healthcare professional, legal, regulatory, and organized customer points of view. Define and deliver TA training content with support from Platform training teams when applicable. Serve as a core member of medical/sci-comms sub-committee(s) of the GMAT. Note: while colleagues will typically focus on one of these areas, there is an expectation that if a business need arises, the team member can adapt and support other functional focus areas. QUALIFICATIONS Bachelor's degree with a minimum of 10 years of relevant biopharmaceutical/biotech or agency experience (such as Medical Communications, Medical Affairs or scientific communications within Clinical Development roles). Advanced scientific degree (PhD, PharmD, MS, etc.) preferred Experience developing strategic scientific communications and other scientific content to support scientific exchange, including the use of tools and programs to meet the needs of HCPs. Have a strong understanding of Medical Affairs, including medical strategies, disease areas, and objectives. Ability to quickly build rapport and credibility with key internal and key external stakeholders through strong interpersonal skills; strong matrix leadership Demonstrated ability to translate complex scientific concepts and data into meaningful and digestible communications and foundational tools that can be utilized via multiple channels including at scientific conferences click apply for full job details
12/13/2025
Full time
ROLE SUMMARY Today, Pfizer Oncology has an industry-leading portfolio of 25 approved innovative cancer medicines, including major therapies for metastatic breast cancer, prostate cancer, urothelial carcinoma, and hematologic malignancies. Pfizer's in-line portfolio is focused on four broad, key areas: breast cancer, genitourinary cancer, hematology, and precision medicine, complemented by an extensive pipeline of over 50 programs in clinical development. The Oncology Scientific Communications Director will report to the Team Lead within Pfizer Oncology Medical Strategy Management The Oncology Scientific Communications Director will lead the development and execution of impactful scientific communication strategies for assigned Pfizer medicines and across their tumor area, with a focus on achieving a singular scientific voice anchored to the evidence. The Director will ensure that overall scientific communication and content strategies reflect TA priorities and that tactical execution of medical and scientific communication activities, specifically focused on optimizing the engagement and reach of emerging scientific information within the oncology community, occurs successfully and according to strategy. This role will focus on achieving a singular scientific voice anchored to the evidence, optimizing the engagement, consistency and reach of emerging scientific information within the oncology community. They will be a subject matter expert in one of the three below chosen capabilities: Therapeutic Area (TA) Scientific Communications: ensure asset strategies and messaging are seamlessly integrated into TA-specific plans and materials. The TA Sci Comms lead will also focus on the delivery of foundational resources such as Scientific Communications Platforms (SCPs), Narratives, and FAQs. Data Disclosure (Publications): Collaborate with TA teams and Sci Comms colleagues to drive the publication planning, writing, and dissemination of scientific data from clinical trials and research activities, ensuring a cohesive and impactful publication strategy across the portfolio. Medical Content: Create a wide range of engaging and informative scientific content for diverse channels and audiences, including medical to medical resources, congress and digital platform content. ROLES AND RESPONSIBILITIES The Director will be responsible for the following, with specific responsibilities varying based on the chosen Sci Comms functional focus area (TA, Data Disclosures, or Content). This role may require working across two functional areas for one product/program. General Responsibilities (applicable to all focus areas): Responsible for ensuring strategic input from a broad range of stakeholders (internal and external) is integrated into scientific communications strategic planning to meet the needs of these stakeholders and especially the Oncology Medical TA teams Support Global Product Teams, Global Medical franchises, and other Pfizer Oncology stakeholders in engaging with the external medical community on activities related to key clinical trial data readouts. Ensure alignment of each product's overall scientific content/communications strategy with relevant Pfizer Oncology stakeholders (e.g., partnering with cross-functional Medical Teams, Channel Excellence, Data Analytics, and other key stakeholders to ensure alignment of communication plans with medical priorities and optimize opportunities for broader data dissemination) Act as a strategic thought partner to the TA medical team, providing sci comms functional guidance and subject matter expertise in their designated focus area Leads financial projections and budget management for functional deliverables in addition to managing agencies and off-shore teams (if applicable) Collaborate with International Medical Channel Content team to ensure sci comms deliverables are shared with country medical colleagues for adaptation Have a thorough understanding of therapeutic area assigned, including policy related issues, and the individual inline and pipeline assets across the specific TAs with an ability either to serve as a primary point of contact for accurate, current medical and scientific knowledge or to identify the appropriate Subject Matter Expert within therapeutic area, for internal and external stakeholders and customers. Responsible for building collaborative relationships with relevant partners in and outside of Medical to ensure optimal creation and execution of channel-specific TA medical communications strategies. Stay abreast of US regulations and guidance that impact digital delivery of scientific information to external HCPs TA Communications: Accountable for strategic oversight of TA scientific communication activities and the overarching scientific communications objectives/strategy/narrative, ensuring alignment and excellence in delivery As a core member of the Global Medical Affairs Team (GMAT), responsible for identifying the need for and establishing the Scientific Communications Platform (SCP) for TA products early in development based on target profile, clinical evidence, disease state/landscape, and aspirational label. For later life-cycle assets, determine the need for and enrich the SCP (based on wide cross-functional input) with evolving evidence from clinical studies, insights, the Clinical Development Plan and regulatory strategy to ensure teams use accurate, consistent language Ensure the product-level SCP is aligned to the broader Therapeutic Area, tumor and/or modality scientific narrative and that information is pulled through to all scientific communication deliverables Establish and maintain the Scientific Communication Platform (SCP) for products in their TA, including overarching scientific communication objectives. In addition to Therapeutic Area and Asset-specific SCPs, the TA Sci Comms lead is responsible for developing global medical narratives and FAQs around key data disclosures Work closely with clinical/medical teams during data readouts to determine key messages (aligned to the SCP) Collaborate with non-Medical stakeholders (e.g. Scientific Affairs, Corporate Communication, etc.) to ensure consistency of scientific communications for non-medical audiences. Orchestrate OLT (Oncology Leadership Team) informs/reviews of key disclosures. Co-chair medical/sci-comms sub-committee(s) of the GMAT Data Disclosure (Publications): Focus: Drive and deliver on data disclosure plans, including Plain Language Summaries (PLS) and Enhanced Publication Content (EPC) Manage author reviews and preparedness Chair Scientific Publications Committees (SPCs) Work closely with clinical study teams during data readouts to determine publication content Ensure updates to global publication plans occur as needed on a regular basis Support GPTs, Global Medical franchises, and other Pfizer Oncology stakeholders by engaging with the external medical community on publication activities. Serve as a core member of medical/sci-comms sub-committee(s) of the GMAT. Content Focus: Lead above or specific-therapeutic area content strategies, projects, digital initiatives and broad enterprise-wide initiatives to advance content impact throughout the organization across all medical content on externally- and internally-facing medical channels Define and deliver external Global and US medical-to-medical content for Field/HQ/Congresses; congress content, digital medical platforms, and content for newly prioritized medical channels. Ensure updates to global congress content occurs as needed on a regular basis in coordination with key cross-functional stakeholders, including commercial, development and Medical TA teams and platforms. Responsible for ensuring the creation of field medical content is aligned with the needs of the Pfizer Oncology Global Medical TA team and regional/local Medical Affairs. Proactively resolve issues around content creation, combining medical affairs expertise with an understanding of the patient, healthcare professional, legal, regulatory, and organized customer points of view. Define and deliver TA training content with support from Platform training teams when applicable. Serve as a core member of medical/sci-comms sub-committee(s) of the GMAT. Note: while colleagues will typically focus on one of these areas, there is an expectation that if a business need arises, the team member can adapt and support other functional focus areas. QUALIFICATIONS Bachelor's degree with a minimum of 10 years of relevant biopharmaceutical/biotech or agency experience (such as Medical Communications, Medical Affairs or scientific communications within Clinical Development roles). Advanced scientific degree (PhD, PharmD, MS, etc.) preferred Experience developing strategic scientific communications and other scientific content to support scientific exchange, including the use of tools and programs to meet the needs of HCPs. Have a strong understanding of Medical Affairs, including medical strategies, disease areas, and objectives. Ability to quickly build rapport and credibility with key internal and key external stakeholders through strong interpersonal skills; strong matrix leadership Demonstrated ability to translate complex scientific concepts and data into meaningful and digestible communications and foundational tools that can be utilized via multiple channels including at scientific conferences click apply for full job details
ROLE SUMMARY Today, Pfizer Oncology has an industry-leading portfolio of 25 approved innovative cancer medicines, including major therapies for metastatic breast cancer, prostate cancer, urothelial carcinoma, and hematologic malignancies. Pfizer's in-line portfolio is focused on four broad, key areas: breast cancer, genitourinary cancer, hematology, and precision medicine, complemented by an extensive pipeline of over 50 programs in clinical development. The Oncology Scientific Communications Director will report to the Team Lead within Pfizer Oncology Medical Strategy Management The Oncology Scientific Communications Director will lead the development and execution of impactful scientific communication strategies for assigned Pfizer medicines and across their tumor area, with a focus on achieving a singular scientific voice anchored to the evidence. The Director will ensure that overall scientific communication and content strategies reflect TA priorities and that tactical execution of medical and scientific communication activities, specifically focused on optimizing the engagement and reach of emerging scientific information within the oncology community, occurs successfully and according to strategy. This role will focus on achieving a singular scientific voice anchored to the evidence, optimizing the engagement, consistency and reach of emerging scientific information within the oncology community. They will be a subject matter expert in one of the three below chosen capabilities: Therapeutic Area (TA) Scientific Communications: ensure asset strategies and messaging are seamlessly integrated into TA-specific plans and materials. The TA Sci Comms lead will also focus on the delivery of foundational resources such as Scientific Communications Platforms (SCPs), Narratives, and FAQs. Data Disclosure (Publications): Collaborate with TA teams and Sci Comms colleagues to drive the publication planning, writing, and dissemination of scientific data from clinical trials and research activities, ensuring a cohesive and impactful publication strategy across the portfolio. Medical Content: Create a wide range of engaging and informative scientific content for diverse channels and audiences, including medical to medical resources, congress and digital platform content. ROLES AND RESPONSIBILITIES The Director will be responsible for the following, with specific responsibilities varying based on the chosen Sci Comms functional focus area (TA, Data Disclosures, or Content). This role may require working across two functional areas for one product/program. General Responsibilities (applicable to all focus areas): Responsible for ensuring strategic input from a broad range of stakeholders (internal and external) is integrated into scientific communications strategic planning to meet the needs of these stakeholders and especially the Oncology Medical TA teams Support Global Product Teams, Global Medical franchises, and other Pfizer Oncology stakeholders in engaging with the external medical community on activities related to key clinical trial data readouts. Ensure alignment of each product's overall scientific content/communications strategy with relevant Pfizer Oncology stakeholders (e.g., partnering with cross-functional Medical Teams, Channel Excellence, Data Analytics, and other key stakeholders to ensure alignment of communication plans with medical priorities and optimize opportunities for broader data dissemination) Act as a strategic thought partner to the TA medical team, providing sci comms functional guidance and subject matter expertise in their designated focus area Leads financial projections and budget management for functional deliverables in addition to managing agencies and off-shore teams (if applicable) Collaborate with International Medical Channel Content team to ensure sci comms deliverables are shared with country medical colleagues for adaptation Have a thorough understanding of therapeutic area assigned, including policy related issues, and the individual inline and pipeline assets across the specific TAs with an ability either to serve as a primary point of contact for accurate, current medical and scientific knowledge or to identify the appropriate Subject Matter Expert within therapeutic area, for internal and external stakeholders and customers. Responsible for building collaborative relationships with relevant partners in and outside of Medical to ensure optimal creation and execution of channel-specific TA medical communications strategies. Stay abreast of US regulations and guidance that impact digital delivery of scientific information to external HCPs TA Communications: Accountable for strategic oversight of TA scientific communication activities and the overarching scientific communications objectives/strategy/narrative, ensuring alignment and excellence in delivery As a core member of the Global Medical Affairs Team (GMAT), responsible for identifying the need for and establishing the Scientific Communications Platform (SCP) for TA products early in development based on target profile, clinical evidence, disease state/landscape, and aspirational label. For later life-cycle assets, determine the need for and enrich the SCP (based on wide cross-functional input) with evolving evidence from clinical studies, insights, the Clinical Development Plan and regulatory strategy to ensure teams use accurate, consistent language Ensure the product-level SCP is aligned to the broader Therapeutic Area, tumor and/or modality scientific narrative and that information is pulled through to all scientific communication deliverables Establish and maintain the Scientific Communication Platform (SCP) for products in their TA, including overarching scientific communication objectives. In addition to Therapeutic Area and Asset-specific SCPs, the TA Sci Comms lead is responsible for developing global medical narratives and FAQs around key data disclosures Work closely with clinical/medical teams during data readouts to determine key messages (aligned to the SCP) Collaborate with non-Medical stakeholders (e.g. Scientific Affairs, Corporate Communication, etc.) to ensure consistency of scientific communications for non-medical audiences. Orchestrate OLT (Oncology Leadership Team) informs/reviews of key disclosures. Co-chair medical/sci-comms sub-committee(s) of the GMAT Data Disclosure (Publications): Focus: Drive and deliver on data disclosure plans, including Plain Language Summaries (PLS) and Enhanced Publication Content (EPC) Manage author reviews and preparedness Chair Scientific Publications Committees (SPCs) Work closely with clinical study teams during data readouts to determine publication content Ensure updates to global publication plans occur as needed on a regular basis Support GPTs, Global Medical franchises, and other Pfizer Oncology stakeholders by engaging with the external medical community on publication activities. Serve as a core member of medical/sci-comms sub-committee(s) of the GMAT. Content Focus: Lead above or specific-therapeutic area content strategies, projects, digital initiatives and broad enterprise-wide initiatives to advance content impact throughout the organization across all medical content on externally- and internally-facing medical channels Define and deliver external Global and US medical-to-medical content for Field/HQ/Congresses; congress content, digital medical platforms, and content for newly prioritized medical channels. Ensure updates to global congress content occurs as needed on a regular basis in coordination with key cross-functional stakeholders, including commercial, development and Medical TA teams and platforms. Responsible for ensuring the creation of field medical content is aligned with the needs of the Pfizer Oncology Global Medical TA team and regional/local Medical Affairs. Proactively resolve issues around content creation, combining medical affairs expertise with an understanding of the patient, healthcare professional, legal, regulatory, and organized customer points of view. Define and deliver TA training content with support from Platform training teams when applicable. Serve as a core member of medical/sci-comms sub-committee(s) of the GMAT. Note: while colleagues will typically focus on one of these areas, there is an expectation that if a business need arises, the team member can adapt and support other functional focus areas. QUALIFICATIONS Bachelor's degree with a minimum of 10 years of relevant biopharmaceutical/biotech or agency experience (such as Medical Communications, Medical Affairs or scientific communications within Clinical Development roles). Advanced scientific degree (PhD, PharmD, MS, etc.) preferred Experience developing strategic scientific communications and other scientific content to support scientific exchange, including the use of tools and programs to meet the needs of HCPs. Have a strong understanding of Medical Affairs, including medical strategies, disease areas, and objectives. Ability to quickly build rapport and credibility with key internal and key external stakeholders through strong interpersonal skills; strong matrix leadership Demonstrated ability to translate complex scientific concepts and data into meaningful and digestible communications and foundational tools that can be utilized via multiple channels including at scientific conferences click apply for full job details
12/13/2025
Full time
ROLE SUMMARY Today, Pfizer Oncology has an industry-leading portfolio of 25 approved innovative cancer medicines, including major therapies for metastatic breast cancer, prostate cancer, urothelial carcinoma, and hematologic malignancies. Pfizer's in-line portfolio is focused on four broad, key areas: breast cancer, genitourinary cancer, hematology, and precision medicine, complemented by an extensive pipeline of over 50 programs in clinical development. The Oncology Scientific Communications Director will report to the Team Lead within Pfizer Oncology Medical Strategy Management The Oncology Scientific Communications Director will lead the development and execution of impactful scientific communication strategies for assigned Pfizer medicines and across their tumor area, with a focus on achieving a singular scientific voice anchored to the evidence. The Director will ensure that overall scientific communication and content strategies reflect TA priorities and that tactical execution of medical and scientific communication activities, specifically focused on optimizing the engagement and reach of emerging scientific information within the oncology community, occurs successfully and according to strategy. This role will focus on achieving a singular scientific voice anchored to the evidence, optimizing the engagement, consistency and reach of emerging scientific information within the oncology community. They will be a subject matter expert in one of the three below chosen capabilities: Therapeutic Area (TA) Scientific Communications: ensure asset strategies and messaging are seamlessly integrated into TA-specific plans and materials. The TA Sci Comms lead will also focus on the delivery of foundational resources such as Scientific Communications Platforms (SCPs), Narratives, and FAQs. Data Disclosure (Publications): Collaborate with TA teams and Sci Comms colleagues to drive the publication planning, writing, and dissemination of scientific data from clinical trials and research activities, ensuring a cohesive and impactful publication strategy across the portfolio. Medical Content: Create a wide range of engaging and informative scientific content for diverse channels and audiences, including medical to medical resources, congress and digital platform content. ROLES AND RESPONSIBILITIES The Director will be responsible for the following, with specific responsibilities varying based on the chosen Sci Comms functional focus area (TA, Data Disclosures, or Content). This role may require working across two functional areas for one product/program. General Responsibilities (applicable to all focus areas): Responsible for ensuring strategic input from a broad range of stakeholders (internal and external) is integrated into scientific communications strategic planning to meet the needs of these stakeholders and especially the Oncology Medical TA teams Support Global Product Teams, Global Medical franchises, and other Pfizer Oncology stakeholders in engaging with the external medical community on activities related to key clinical trial data readouts. Ensure alignment of each product's overall scientific content/communications strategy with relevant Pfizer Oncology stakeholders (e.g., partnering with cross-functional Medical Teams, Channel Excellence, Data Analytics, and other key stakeholders to ensure alignment of communication plans with medical priorities and optimize opportunities for broader data dissemination) Act as a strategic thought partner to the TA medical team, providing sci comms functional guidance and subject matter expertise in their designated focus area Leads financial projections and budget management for functional deliverables in addition to managing agencies and off-shore teams (if applicable) Collaborate with International Medical Channel Content team to ensure sci comms deliverables are shared with country medical colleagues for adaptation Have a thorough understanding of therapeutic area assigned, including policy related issues, and the individual inline and pipeline assets across the specific TAs with an ability either to serve as a primary point of contact for accurate, current medical and scientific knowledge or to identify the appropriate Subject Matter Expert within therapeutic area, for internal and external stakeholders and customers. Responsible for building collaborative relationships with relevant partners in and outside of Medical to ensure optimal creation and execution of channel-specific TA medical communications strategies. Stay abreast of US regulations and guidance that impact digital delivery of scientific information to external HCPs TA Communications: Accountable for strategic oversight of TA scientific communication activities and the overarching scientific communications objectives/strategy/narrative, ensuring alignment and excellence in delivery As a core member of the Global Medical Affairs Team (GMAT), responsible for identifying the need for and establishing the Scientific Communications Platform (SCP) for TA products early in development based on target profile, clinical evidence, disease state/landscape, and aspirational label. For later life-cycle assets, determine the need for and enrich the SCP (based on wide cross-functional input) with evolving evidence from clinical studies, insights, the Clinical Development Plan and regulatory strategy to ensure teams use accurate, consistent language Ensure the product-level SCP is aligned to the broader Therapeutic Area, tumor and/or modality scientific narrative and that information is pulled through to all scientific communication deliverables Establish and maintain the Scientific Communication Platform (SCP) for products in their TA, including overarching scientific communication objectives. In addition to Therapeutic Area and Asset-specific SCPs, the TA Sci Comms lead is responsible for developing global medical narratives and FAQs around key data disclosures Work closely with clinical/medical teams during data readouts to determine key messages (aligned to the SCP) Collaborate with non-Medical stakeholders (e.g. Scientific Affairs, Corporate Communication, etc.) to ensure consistency of scientific communications for non-medical audiences. Orchestrate OLT (Oncology Leadership Team) informs/reviews of key disclosures. Co-chair medical/sci-comms sub-committee(s) of the GMAT Data Disclosure (Publications): Focus: Drive and deliver on data disclosure plans, including Plain Language Summaries (PLS) and Enhanced Publication Content (EPC) Manage author reviews and preparedness Chair Scientific Publications Committees (SPCs) Work closely with clinical study teams during data readouts to determine publication content Ensure updates to global publication plans occur as needed on a regular basis Support GPTs, Global Medical franchises, and other Pfizer Oncology stakeholders by engaging with the external medical community on publication activities. Serve as a core member of medical/sci-comms sub-committee(s) of the GMAT. Content Focus: Lead above or specific-therapeutic area content strategies, projects, digital initiatives and broad enterprise-wide initiatives to advance content impact throughout the organization across all medical content on externally- and internally-facing medical channels Define and deliver external Global and US medical-to-medical content for Field/HQ/Congresses; congress content, digital medical platforms, and content for newly prioritized medical channels. Ensure updates to global congress content occurs as needed on a regular basis in coordination with key cross-functional stakeholders, including commercial, development and Medical TA teams and platforms. Responsible for ensuring the creation of field medical content is aligned with the needs of the Pfizer Oncology Global Medical TA team and regional/local Medical Affairs. Proactively resolve issues around content creation, combining medical affairs expertise with an understanding of the patient, healthcare professional, legal, regulatory, and organized customer points of view. Define and deliver TA training content with support from Platform training teams when applicable. Serve as a core member of medical/sci-comms sub-committee(s) of the GMAT. Note: while colleagues will typically focus on one of these areas, there is an expectation that if a business need arises, the team member can adapt and support other functional focus areas. QUALIFICATIONS Bachelor's degree with a minimum of 10 years of relevant biopharmaceutical/biotech or agency experience (such as Medical Communications, Medical Affairs or scientific communications within Clinical Development roles). Advanced scientific degree (PhD, PharmD, MS, etc.) preferred Experience developing strategic scientific communications and other scientific content to support scientific exchange, including the use of tools and programs to meet the needs of HCPs. Have a strong understanding of Medical Affairs, including medical strategies, disease areas, and objectives. Ability to quickly build rapport and credibility with key internal and key external stakeholders through strong interpersonal skills; strong matrix leadership Demonstrated ability to translate complex scientific concepts and data into meaningful and digestible communications and foundational tools that can be utilized via multiple channels including at scientific conferences click apply for full job details
ROLE SUMMARY Today, Pfizer Oncology has an industry-leading portfolio of 25 approved innovative cancer medicines, including major therapies for metastatic breast cancer, prostate cancer, urothelial carcinoma, and hematologic malignancies. Pfizer's in-line portfolio is focused on four broad, key areas: breast cancer, genitourinary cancer, hematology, and precision medicine, complemented by an extensive pipeline of over 50 programs in clinical development. The Oncology Scientific Communications Director will report to the Team Lead within Pfizer Oncology Medical Strategy Management The Oncology Scientific Communications Director will lead the development and execution of impactful scientific communication strategies for assigned Pfizer medicines and across their tumor area, with a focus on achieving a singular scientific voice anchored to the evidence. The Director will ensure that overall scientific communication and content strategies reflect TA priorities and that tactical execution of medical and scientific communication activities, specifically focused on optimizing the engagement and reach of emerging scientific information within the oncology community, occurs successfully and according to strategy. This role will focus on achieving a singular scientific voice anchored to the evidence, optimizing the engagement, consistency and reach of emerging scientific information within the oncology community. They will be a subject matter expert in one of the three below chosen capabilities: Therapeutic Area (TA) Scientific Communications: ensure asset strategies and messaging are seamlessly integrated into TA-specific plans and materials. The TA Sci Comms lead will also focus on the delivery of foundational resources such as Scientific Communications Platforms (SCPs), Narratives, and FAQs. Data Disclosure (Publications): Collaborate with TA teams and Sci Comms colleagues to drive the publication planning, writing, and dissemination of scientific data from clinical trials and research activities, ensuring a cohesive and impactful publication strategy across the portfolio. Medical Content: Create a wide range of engaging and informative scientific content for diverse channels and audiences, including medical to medical resources, congress and digital platform content. ROLES AND RESPONSIBILITIES The Director will be responsible for the following, with specific responsibilities varying based on the chosen Sci Comms functional focus area (TA, Data Disclosures, or Content). This role may require working across two functional areas for one product/program. General Responsibilities (applicable to all focus areas): Responsible for ensuring strategic input from a broad range of stakeholders (internal and external) is integrated into scientific communications strategic planning to meet the needs of these stakeholders and especially the Oncology Medical TA teams Support Global Product Teams, Global Medical franchises, and other Pfizer Oncology stakeholders in engaging with the external medical community on activities related to key clinical trial data readouts. Ensure alignment of each product's overall scientific content/communications strategy with relevant Pfizer Oncology stakeholders (e.g., partnering with cross-functional Medical Teams, Channel Excellence, Data Analytics, and other key stakeholders to ensure alignment of communication plans with medical priorities and optimize opportunities for broader data dissemination) Act as a strategic thought partner to the TA medical team, providing sci comms functional guidance and subject matter expertise in their designated focus area Leads financial projections and budget management for functional deliverables in addition to managing agencies and off-shore teams (if applicable) Collaborate with International Medical Channel Content team to ensure sci comms deliverables are shared with country medical colleagues for adaptation Have a thorough understanding of therapeutic area assigned, including policy related issues, and the individual inline and pipeline assets across the specific TAs with an ability either to serve as a primary point of contact for accurate, current medical and scientific knowledge or to identify the appropriate Subject Matter Expert within therapeutic area, for internal and external stakeholders and customers. Responsible for building collaborative relationships with relevant partners in and outside of Medical to ensure optimal creation and execution of channel-specific TA medical communications strategies. Stay abreast of US regulations and guidance that impact digital delivery of scientific information to external HCPs TA Communications: Accountable for strategic oversight of TA scientific communication activities and the overarching scientific communications objectives/strategy/narrative, ensuring alignment and excellence in delivery As a core member of the Global Medical Affairs Team (GMAT), responsible for identifying the need for and establishing the Scientific Communications Platform (SCP) for TA products early in development based on target profile, clinical evidence, disease state/landscape, and aspirational label. For later life-cycle assets, determine the need for and enrich the SCP (based on wide cross-functional input) with evolving evidence from clinical studies, insights, the Clinical Development Plan and regulatory strategy to ensure teams use accurate, consistent language Ensure the product-level SCP is aligned to the broader Therapeutic Area, tumor and/or modality scientific narrative and that information is pulled through to all scientific communication deliverables Establish and maintain the Scientific Communication Platform (SCP) for products in their TA, including overarching scientific communication objectives. In addition to Therapeutic Area and Asset-specific SCPs, the TA Sci Comms lead is responsible for developing global medical narratives and FAQs around key data disclosures Work closely with clinical/medical teams during data readouts to determine key messages (aligned to the SCP) Collaborate with non-Medical stakeholders (e.g. Scientific Affairs, Corporate Communication, etc.) to ensure consistency of scientific communications for non-medical audiences. Orchestrate OLT (Oncology Leadership Team) informs/reviews of key disclosures. Co-chair medical/sci-comms sub-committee(s) of the GMAT Data Disclosure (Publications): Focus: Drive and deliver on data disclosure plans, including Plain Language Summaries (PLS) and Enhanced Publication Content (EPC) Manage author reviews and preparedness Chair Scientific Publications Committees (SPCs) Work closely with clinical study teams during data readouts to determine publication content Ensure updates to global publication plans occur as needed on a regular basis Support GPTs, Global Medical franchises, and other Pfizer Oncology stakeholders by engaging with the external medical community on publication activities. Serve as a core member of medical/sci-comms sub-committee(s) of the GMAT. Content Focus: Lead above or specific-therapeutic area content strategies, projects, digital initiatives and broad enterprise-wide initiatives to advance content impact throughout the organization across all medical content on externally- and internally-facing medical channels Define and deliver external Global and US medical-to-medical content for Field/HQ/Congresses; congress content, digital medical platforms, and content for newly prioritized medical channels. Ensure updates to global congress content occurs as needed on a regular basis in coordination with key cross-functional stakeholders, including commercial, development and Medical TA teams and platforms. Responsible for ensuring the creation of field medical content is aligned with the needs of the Pfizer Oncology Global Medical TA team and regional/local Medical Affairs. Proactively resolve issues around content creation, combining medical affairs expertise with an understanding of the patient, healthcare professional, legal, regulatory, and organized customer points of view. Define and deliver TA training content with support from Platform training teams when applicable. Serve as a core member of medical/sci-comms sub-committee(s) of the GMAT. Note: while colleagues will typically focus on one of these areas, there is an expectation that if a business need arises, the team member can adapt and support other functional focus areas. QUALIFICATIONS Bachelor's degree with a minimum of 10 years of relevant biopharmaceutical/biotech or agency experience (such as Medical Communications, Medical Affairs or scientific communications within Clinical Development roles). Advanced scientific degree (PhD, PharmD, MS, etc.) preferred Experience developing strategic scientific communications and other scientific content to support scientific exchange, including the use of tools and programs to meet the needs of HCPs. Have a strong understanding of Medical Affairs, including medical strategies, disease areas, and objectives. Ability to quickly build rapport and credibility with key internal and key external stakeholders through strong interpersonal skills; strong matrix leadership Demonstrated ability to translate complex scientific concepts and data into meaningful and digestible communications and foundational tools that can be utilized via multiple channels including at scientific conferences click apply for full job details
12/13/2025
Full time
ROLE SUMMARY Today, Pfizer Oncology has an industry-leading portfolio of 25 approved innovative cancer medicines, including major therapies for metastatic breast cancer, prostate cancer, urothelial carcinoma, and hematologic malignancies. Pfizer's in-line portfolio is focused on four broad, key areas: breast cancer, genitourinary cancer, hematology, and precision medicine, complemented by an extensive pipeline of over 50 programs in clinical development. The Oncology Scientific Communications Director will report to the Team Lead within Pfizer Oncology Medical Strategy Management The Oncology Scientific Communications Director will lead the development and execution of impactful scientific communication strategies for assigned Pfizer medicines and across their tumor area, with a focus on achieving a singular scientific voice anchored to the evidence. The Director will ensure that overall scientific communication and content strategies reflect TA priorities and that tactical execution of medical and scientific communication activities, specifically focused on optimizing the engagement and reach of emerging scientific information within the oncology community, occurs successfully and according to strategy. This role will focus on achieving a singular scientific voice anchored to the evidence, optimizing the engagement, consistency and reach of emerging scientific information within the oncology community. They will be a subject matter expert in one of the three below chosen capabilities: Therapeutic Area (TA) Scientific Communications: ensure asset strategies and messaging are seamlessly integrated into TA-specific plans and materials. The TA Sci Comms lead will also focus on the delivery of foundational resources such as Scientific Communications Platforms (SCPs), Narratives, and FAQs. Data Disclosure (Publications): Collaborate with TA teams and Sci Comms colleagues to drive the publication planning, writing, and dissemination of scientific data from clinical trials and research activities, ensuring a cohesive and impactful publication strategy across the portfolio. Medical Content: Create a wide range of engaging and informative scientific content for diverse channels and audiences, including medical to medical resources, congress and digital platform content. ROLES AND RESPONSIBILITIES The Director will be responsible for the following, with specific responsibilities varying based on the chosen Sci Comms functional focus area (TA, Data Disclosures, or Content). This role may require working across two functional areas for one product/program. General Responsibilities (applicable to all focus areas): Responsible for ensuring strategic input from a broad range of stakeholders (internal and external) is integrated into scientific communications strategic planning to meet the needs of these stakeholders and especially the Oncology Medical TA teams Support Global Product Teams, Global Medical franchises, and other Pfizer Oncology stakeholders in engaging with the external medical community on activities related to key clinical trial data readouts. Ensure alignment of each product's overall scientific content/communications strategy with relevant Pfizer Oncology stakeholders (e.g., partnering with cross-functional Medical Teams, Channel Excellence, Data Analytics, and other key stakeholders to ensure alignment of communication plans with medical priorities and optimize opportunities for broader data dissemination) Act as a strategic thought partner to the TA medical team, providing sci comms functional guidance and subject matter expertise in their designated focus area Leads financial projections and budget management for functional deliverables in addition to managing agencies and off-shore teams (if applicable) Collaborate with International Medical Channel Content team to ensure sci comms deliverables are shared with country medical colleagues for adaptation Have a thorough understanding of therapeutic area assigned, including policy related issues, and the individual inline and pipeline assets across the specific TAs with an ability either to serve as a primary point of contact for accurate, current medical and scientific knowledge or to identify the appropriate Subject Matter Expert within therapeutic area, for internal and external stakeholders and customers. Responsible for building collaborative relationships with relevant partners in and outside of Medical to ensure optimal creation and execution of channel-specific TA medical communications strategies. Stay abreast of US regulations and guidance that impact digital delivery of scientific information to external HCPs TA Communications: Accountable for strategic oversight of TA scientific communication activities and the overarching scientific communications objectives/strategy/narrative, ensuring alignment and excellence in delivery As a core member of the Global Medical Affairs Team (GMAT), responsible for identifying the need for and establishing the Scientific Communications Platform (SCP) for TA products early in development based on target profile, clinical evidence, disease state/landscape, and aspirational label. For later life-cycle assets, determine the need for and enrich the SCP (based on wide cross-functional input) with evolving evidence from clinical studies, insights, the Clinical Development Plan and regulatory strategy to ensure teams use accurate, consistent language Ensure the product-level SCP is aligned to the broader Therapeutic Area, tumor and/or modality scientific narrative and that information is pulled through to all scientific communication deliverables Establish and maintain the Scientific Communication Platform (SCP) for products in their TA, including overarching scientific communication objectives. In addition to Therapeutic Area and Asset-specific SCPs, the TA Sci Comms lead is responsible for developing global medical narratives and FAQs around key data disclosures Work closely with clinical/medical teams during data readouts to determine key messages (aligned to the SCP) Collaborate with non-Medical stakeholders (e.g. Scientific Affairs, Corporate Communication, etc.) to ensure consistency of scientific communications for non-medical audiences. Orchestrate OLT (Oncology Leadership Team) informs/reviews of key disclosures. Co-chair medical/sci-comms sub-committee(s) of the GMAT Data Disclosure (Publications): Focus: Drive and deliver on data disclosure plans, including Plain Language Summaries (PLS) and Enhanced Publication Content (EPC) Manage author reviews and preparedness Chair Scientific Publications Committees (SPCs) Work closely with clinical study teams during data readouts to determine publication content Ensure updates to global publication plans occur as needed on a regular basis Support GPTs, Global Medical franchises, and other Pfizer Oncology stakeholders by engaging with the external medical community on publication activities. Serve as a core member of medical/sci-comms sub-committee(s) of the GMAT. Content Focus: Lead above or specific-therapeutic area content strategies, projects, digital initiatives and broad enterprise-wide initiatives to advance content impact throughout the organization across all medical content on externally- and internally-facing medical channels Define and deliver external Global and US medical-to-medical content for Field/HQ/Congresses; congress content, digital medical platforms, and content for newly prioritized medical channels. Ensure updates to global congress content occurs as needed on a regular basis in coordination with key cross-functional stakeholders, including commercial, development and Medical TA teams and platforms. Responsible for ensuring the creation of field medical content is aligned with the needs of the Pfizer Oncology Global Medical TA team and regional/local Medical Affairs. Proactively resolve issues around content creation, combining medical affairs expertise with an understanding of the patient, healthcare professional, legal, regulatory, and organized customer points of view. Define and deliver TA training content with support from Platform training teams when applicable. Serve as a core member of medical/sci-comms sub-committee(s) of the GMAT. Note: while colleagues will typically focus on one of these areas, there is an expectation that if a business need arises, the team member can adapt and support other functional focus areas. QUALIFICATIONS Bachelor's degree with a minimum of 10 years of relevant biopharmaceutical/biotech or agency experience (such as Medical Communications, Medical Affairs or scientific communications within Clinical Development roles). Advanced scientific degree (PhD, PharmD, MS, etc.) preferred Experience developing strategic scientific communications and other scientific content to support scientific exchange, including the use of tools and programs to meet the needs of HCPs. Have a strong understanding of Medical Affairs, including medical strategies, disease areas, and objectives. Ability to quickly build rapport and credibility with key internal and key external stakeholders through strong interpersonal skills; strong matrix leadership Demonstrated ability to translate complex scientific concepts and data into meaningful and digestible communications and foundational tools that can be utilized via multiple channels including at scientific conferences click apply for full job details
ROLE SUMMARY Today, Pfizer Oncology has an industry-leading portfolio of 25 approved innovative cancer medicines, including major therapies for metastatic breast cancer, prostate cancer, urothelial carcinoma, and hematologic malignancies. Pfizer's in-line portfolio is focused on four broad, key areas: breast cancer, genitourinary cancer, hematology, and precision medicine, complemented by an extensive pipeline of over 50 programs in clinical development. The Oncology Scientific Communications Director will report to the Team Lead within Pfizer Oncology Medical Strategy Management The Oncology Scientific Communications Director will lead the development and execution of impactful scientific communication strategies for assigned Pfizer medicines and across their tumor area, with a focus on achieving a singular scientific voice anchored to the evidence. The Director will ensure that overall scientific communication and content strategies reflect TA priorities and that tactical execution of medical and scientific communication activities, specifically focused on optimizing the engagement and reach of emerging scientific information within the oncology community, occurs successfully and according to strategy. This role will focus on achieving a singular scientific voice anchored to the evidence, optimizing the engagement, consistency and reach of emerging scientific information within the oncology community. They will be a subject matter expert in one of the three below chosen capabilities: Therapeutic Area (TA) Scientific Communications: ensure asset strategies and messaging are seamlessly integrated into TA-specific plans and materials. The TA Sci Comms lead will also focus on the delivery of foundational resources such as Scientific Communications Platforms (SCPs), Narratives, and FAQs. Data Disclosure (Publications): Collaborate with TA teams and Sci Comms colleagues to drive the publication planning, writing, and dissemination of scientific data from clinical trials and research activities, ensuring a cohesive and impactful publication strategy across the portfolio. Medical Content: Create a wide range of engaging and informative scientific content for diverse channels and audiences, including medical to medical resources, congress and digital platform content. ROLES AND RESPONSIBILITIES The Director will be responsible for the following, with specific responsibilities varying based on the chosen Sci Comms functional focus area (TA, Data Disclosures, or Content). This role may require working across two functional areas for one product/program. General Responsibilities (applicable to all focus areas): Responsible for ensuring strategic input from a broad range of stakeholders (internal and external) is integrated into scientific communications strategic planning to meet the needs of these stakeholders and especially the Oncology Medical TA teams Support Global Product Teams, Global Medical franchises, and other Pfizer Oncology stakeholders in engaging with the external medical community on activities related to key clinical trial data readouts. Ensure alignment of each product's overall scientific content/communications strategy with relevant Pfizer Oncology stakeholders (e.g., partnering with cross-functional Medical Teams, Channel Excellence, Data Analytics, and other key stakeholders to ensure alignment of communication plans with medical priorities and optimize opportunities for broader data dissemination) Act as a strategic thought partner to the TA medical team, providing sci comms functional guidance and subject matter expertise in their designated focus area Leads financial projections and budget management for functional deliverables in addition to managing agencies and off-shore teams (if applicable) Collaborate with International Medical Channel Content team to ensure sci comms deliverables are shared with country medical colleagues for adaptation Have a thorough understanding of therapeutic area assigned, including policy related issues, and the individual inline and pipeline assets across the specific TAs with an ability either to serve as a primary point of contact for accurate, current medical and scientific knowledge or to identify the appropriate Subject Matter Expert within therapeutic area, for internal and external stakeholders and customers. Responsible for building collaborative relationships with relevant partners in and outside of Medical to ensure optimal creation and execution of channel-specific TA medical communications strategies. Stay abreast of US regulations and guidance that impact digital delivery of scientific information to external HCPs TA Communications: Accountable for strategic oversight of TA scientific communication activities and the overarching scientific communications objectives/strategy/narrative, ensuring alignment and excellence in delivery As a core member of the Global Medical Affairs Team (GMAT), responsible for identifying the need for and establishing the Scientific Communications Platform (SCP) for TA products early in development based on target profile, clinical evidence, disease state/landscape, and aspirational label. For later life-cycle assets, determine the need for and enrich the SCP (based on wide cross-functional input) with evolving evidence from clinical studies, insights, the Clinical Development Plan and regulatory strategy to ensure teams use accurate, consistent language Ensure the product-level SCP is aligned to the broader Therapeutic Area, tumor and/or modality scientific narrative and that information is pulled through to all scientific communication deliverables Establish and maintain the Scientific Communication Platform (SCP) for products in their TA, including overarching scientific communication objectives. In addition to Therapeutic Area and Asset-specific SCPs, the TA Sci Comms lead is responsible for developing global medical narratives and FAQs around key data disclosures Work closely with clinical/medical teams during data readouts to determine key messages (aligned to the SCP) Collaborate with non-Medical stakeholders (e.g. Scientific Affairs, Corporate Communication, etc.) to ensure consistency of scientific communications for non-medical audiences. Orchestrate OLT (Oncology Leadership Team) informs/reviews of key disclosures. Co-chair medical/sci-comms sub-committee(s) of the GMAT Data Disclosure (Publications): Focus: Drive and deliver on data disclosure plans, including Plain Language Summaries (PLS) and Enhanced Publication Content (EPC) Manage author reviews and preparedness Chair Scientific Publications Committees (SPCs) Work closely with clinical study teams during data readouts to determine publication content Ensure updates to global publication plans occur as needed on a regular basis Support GPTs, Global Medical franchises, and other Pfizer Oncology stakeholders by engaging with the external medical community on publication activities. Serve as a core member of medical/sci-comms sub-committee(s) of the GMAT. Content Focus: Lead above or specific-therapeutic area content strategies, projects, digital initiatives and broad enterprise-wide initiatives to advance content impact throughout the organization across all medical content on externally- and internally-facing medical channels Define and deliver external Global and US medical-to-medical content for Field/HQ/Congresses; congress content, digital medical platforms, and content for newly prioritized medical channels. Ensure updates to global congress content occurs as needed on a regular basis in coordination with key cross-functional stakeholders, including commercial, development and Medical TA teams and platforms. Responsible for ensuring the creation of field medical content is aligned with the needs of the Pfizer Oncology Global Medical TA team and regional/local Medical Affairs. Proactively resolve issues around content creation, combining medical affairs expertise with an understanding of the patient, healthcare professional, legal, regulatory, and organized customer points of view. Define and deliver TA training content with support from Platform training teams when applicable. Serve as a core member of medical/sci-comms sub-committee(s) of the GMAT. Note: while colleagues will typically focus on one of these areas, there is an expectation that if a business need arises, the team member can adapt and support other functional focus areas. QUALIFICATIONS Bachelor's degree with a minimum of 10 years of relevant biopharmaceutical/biotech or agency experience (such as Medical Communications, Medical Affairs or scientific communications within Clinical Development roles). Advanced scientific degree (PhD, PharmD, MS, etc.) preferred Experience developing strategic scientific communications and other scientific content to support scientific exchange, including the use of tools and programs to meet the needs of HCPs. Have a strong understanding of Medical Affairs, including medical strategies, disease areas, and objectives. Ability to quickly build rapport and credibility with key internal and key external stakeholders through strong interpersonal skills; strong matrix leadership Demonstrated ability to translate complex scientific concepts and data into meaningful and digestible communications and foundational tools that can be utilized via multiple channels including at scientific conferences click apply for full job details
12/13/2025
Full time
ROLE SUMMARY Today, Pfizer Oncology has an industry-leading portfolio of 25 approved innovative cancer medicines, including major therapies for metastatic breast cancer, prostate cancer, urothelial carcinoma, and hematologic malignancies. Pfizer's in-line portfolio is focused on four broad, key areas: breast cancer, genitourinary cancer, hematology, and precision medicine, complemented by an extensive pipeline of over 50 programs in clinical development. The Oncology Scientific Communications Director will report to the Team Lead within Pfizer Oncology Medical Strategy Management The Oncology Scientific Communications Director will lead the development and execution of impactful scientific communication strategies for assigned Pfizer medicines and across their tumor area, with a focus on achieving a singular scientific voice anchored to the evidence. The Director will ensure that overall scientific communication and content strategies reflect TA priorities and that tactical execution of medical and scientific communication activities, specifically focused on optimizing the engagement and reach of emerging scientific information within the oncology community, occurs successfully and according to strategy. This role will focus on achieving a singular scientific voice anchored to the evidence, optimizing the engagement, consistency and reach of emerging scientific information within the oncology community. They will be a subject matter expert in one of the three below chosen capabilities: Therapeutic Area (TA) Scientific Communications: ensure asset strategies and messaging are seamlessly integrated into TA-specific plans and materials. The TA Sci Comms lead will also focus on the delivery of foundational resources such as Scientific Communications Platforms (SCPs), Narratives, and FAQs. Data Disclosure (Publications): Collaborate with TA teams and Sci Comms colleagues to drive the publication planning, writing, and dissemination of scientific data from clinical trials and research activities, ensuring a cohesive and impactful publication strategy across the portfolio. Medical Content: Create a wide range of engaging and informative scientific content for diverse channels and audiences, including medical to medical resources, congress and digital platform content. ROLES AND RESPONSIBILITIES The Director will be responsible for the following, with specific responsibilities varying based on the chosen Sci Comms functional focus area (TA, Data Disclosures, or Content). This role may require working across two functional areas for one product/program. General Responsibilities (applicable to all focus areas): Responsible for ensuring strategic input from a broad range of stakeholders (internal and external) is integrated into scientific communications strategic planning to meet the needs of these stakeholders and especially the Oncology Medical TA teams Support Global Product Teams, Global Medical franchises, and other Pfizer Oncology stakeholders in engaging with the external medical community on activities related to key clinical trial data readouts. Ensure alignment of each product's overall scientific content/communications strategy with relevant Pfizer Oncology stakeholders (e.g., partnering with cross-functional Medical Teams, Channel Excellence, Data Analytics, and other key stakeholders to ensure alignment of communication plans with medical priorities and optimize opportunities for broader data dissemination) Act as a strategic thought partner to the TA medical team, providing sci comms functional guidance and subject matter expertise in their designated focus area Leads financial projections and budget management for functional deliverables in addition to managing agencies and off-shore teams (if applicable) Collaborate with International Medical Channel Content team to ensure sci comms deliverables are shared with country medical colleagues for adaptation Have a thorough understanding of therapeutic area assigned, including policy related issues, and the individual inline and pipeline assets across the specific TAs with an ability either to serve as a primary point of contact for accurate, current medical and scientific knowledge or to identify the appropriate Subject Matter Expert within therapeutic area, for internal and external stakeholders and customers. Responsible for building collaborative relationships with relevant partners in and outside of Medical to ensure optimal creation and execution of channel-specific TA medical communications strategies. Stay abreast of US regulations and guidance that impact digital delivery of scientific information to external HCPs TA Communications: Accountable for strategic oversight of TA scientific communication activities and the overarching scientific communications objectives/strategy/narrative, ensuring alignment and excellence in delivery As a core member of the Global Medical Affairs Team (GMAT), responsible for identifying the need for and establishing the Scientific Communications Platform (SCP) for TA products early in development based on target profile, clinical evidence, disease state/landscape, and aspirational label. For later life-cycle assets, determine the need for and enrich the SCP (based on wide cross-functional input) with evolving evidence from clinical studies, insights, the Clinical Development Plan and regulatory strategy to ensure teams use accurate, consistent language Ensure the product-level SCP is aligned to the broader Therapeutic Area, tumor and/or modality scientific narrative and that information is pulled through to all scientific communication deliverables Establish and maintain the Scientific Communication Platform (SCP) for products in their TA, including overarching scientific communication objectives. In addition to Therapeutic Area and Asset-specific SCPs, the TA Sci Comms lead is responsible for developing global medical narratives and FAQs around key data disclosures Work closely with clinical/medical teams during data readouts to determine key messages (aligned to the SCP) Collaborate with non-Medical stakeholders (e.g. Scientific Affairs, Corporate Communication, etc.) to ensure consistency of scientific communications for non-medical audiences. Orchestrate OLT (Oncology Leadership Team) informs/reviews of key disclosures. Co-chair medical/sci-comms sub-committee(s) of the GMAT Data Disclosure (Publications): Focus: Drive and deliver on data disclosure plans, including Plain Language Summaries (PLS) and Enhanced Publication Content (EPC) Manage author reviews and preparedness Chair Scientific Publications Committees (SPCs) Work closely with clinical study teams during data readouts to determine publication content Ensure updates to global publication plans occur as needed on a regular basis Support GPTs, Global Medical franchises, and other Pfizer Oncology stakeholders by engaging with the external medical community on publication activities. Serve as a core member of medical/sci-comms sub-committee(s) of the GMAT. Content Focus: Lead above or specific-therapeutic area content strategies, projects, digital initiatives and broad enterprise-wide initiatives to advance content impact throughout the organization across all medical content on externally- and internally-facing medical channels Define and deliver external Global and US medical-to-medical content for Field/HQ/Congresses; congress content, digital medical platforms, and content for newly prioritized medical channels. Ensure updates to global congress content occurs as needed on a regular basis in coordination with key cross-functional stakeholders, including commercial, development and Medical TA teams and platforms. Responsible for ensuring the creation of field medical content is aligned with the needs of the Pfizer Oncology Global Medical TA team and regional/local Medical Affairs. Proactively resolve issues around content creation, combining medical affairs expertise with an understanding of the patient, healthcare professional, legal, regulatory, and organized customer points of view. Define and deliver TA training content with support from Platform training teams when applicable. Serve as a core member of medical/sci-comms sub-committee(s) of the GMAT. Note: while colleagues will typically focus on one of these areas, there is an expectation that if a business need arises, the team member can adapt and support other functional focus areas. QUALIFICATIONS Bachelor's degree with a minimum of 10 years of relevant biopharmaceutical/biotech or agency experience (such as Medical Communications, Medical Affairs or scientific communications within Clinical Development roles). Advanced scientific degree (PhD, PharmD, MS, etc.) preferred Experience developing strategic scientific communications and other scientific content to support scientific exchange, including the use of tools and programs to meet the needs of HCPs. Have a strong understanding of Medical Affairs, including medical strategies, disease areas, and objectives. Ability to quickly build rapport and credibility with key internal and key external stakeholders through strong interpersonal skills; strong matrix leadership Demonstrated ability to translate complex scientific concepts and data into meaningful and digestible communications and foundational tools that can be utilized via multiple channels including at scientific conferences click apply for full job details
ROLE SUMMARY Today, Pfizer Oncology has an industry-leading portfolio of 25 approved innovative cancer medicines, including major therapies for metastatic breast cancer, prostate cancer, urothelial carcinoma, and hematologic malignancies. Pfizer's in-line portfolio is focused on four broad, key areas: breast cancer, genitourinary cancer, hematology, and precision medicine, complemented by an extensive pipeline of over 50 programs in clinical development. The Oncology Scientific Communications Director will report to the Team Lead within Pfizer Oncology Medical Strategy Management The Oncology Scientific Communications Director will lead the development and execution of impactful scientific communication strategies for assigned Pfizer medicines and across their tumor area, with a focus on achieving a singular scientific voice anchored to the evidence. The Director will ensure that overall scientific communication and content strategies reflect TA priorities and that tactical execution of medical and scientific communication activities, specifically focused on optimizing the engagement and reach of emerging scientific information within the oncology community, occurs successfully and according to strategy. This role will focus on achieving a singular scientific voice anchored to the evidence, optimizing the engagement, consistency and reach of emerging scientific information within the oncology community. They will be a subject matter expert in one of the three below chosen capabilities: Therapeutic Area (TA) Scientific Communications: ensure asset strategies and messaging are seamlessly integrated into TA-specific plans and materials. The TA Sci Comms lead will also focus on the delivery of foundational resources such as Scientific Communications Platforms (SCPs), Narratives, and FAQs. Data Disclosure (Publications): Collaborate with TA teams and Sci Comms colleagues to drive the publication planning, writing, and dissemination of scientific data from clinical trials and research activities, ensuring a cohesive and impactful publication strategy across the portfolio. Medical Content: Create a wide range of engaging and informative scientific content for diverse channels and audiences, including medical to medical resources, congress and digital platform content. ROLES AND RESPONSIBILITIES The Director will be responsible for the following, with specific responsibilities varying based on the chosen Sci Comms functional focus area (TA, Data Disclosures, or Content). This role may require working across two functional areas for one product/program. General Responsibilities (applicable to all focus areas): Responsible for ensuring strategic input from a broad range of stakeholders (internal and external) is integrated into scientific communications strategic planning to meet the needs of these stakeholders and especially the Oncology Medical TA teams Support Global Product Teams, Global Medical franchises, and other Pfizer Oncology stakeholders in engaging with the external medical community on activities related to key clinical trial data readouts. Ensure alignment of each product's overall scientific content/communications strategy with relevant Pfizer Oncology stakeholders (e.g., partnering with cross-functional Medical Teams, Channel Excellence, Data Analytics, and other key stakeholders to ensure alignment of communication plans with medical priorities and optimize opportunities for broader data dissemination) Act as a strategic thought partner to the TA medical team, providing sci comms functional guidance and subject matter expertise in their designated focus area Leads financial projections and budget management for functional deliverables in addition to managing agencies and off-shore teams (if applicable) Collaborate with International Medical Channel Content team to ensure sci comms deliverables are shared with country medical colleagues for adaptation Have a thorough understanding of therapeutic area assigned, including policy related issues, and the individual inline and pipeline assets across the specific TAs with an ability either to serve as a primary point of contact for accurate, current medical and scientific knowledge or to identify the appropriate Subject Matter Expert within therapeutic area, for internal and external stakeholders and customers. Responsible for building collaborative relationships with relevant partners in and outside of Medical to ensure optimal creation and execution of channel-specific TA medical communications strategies. Stay abreast of US regulations and guidance that impact digital delivery of scientific information to external HCPs TA Communications: Accountable for strategic oversight of TA scientific communication activities and the overarching scientific communications objectives/strategy/narrative, ensuring alignment and excellence in delivery As a core member of the Global Medical Affairs Team (GMAT), responsible for identifying the need for and establishing the Scientific Communications Platform (SCP) for TA products early in development based on target profile, clinical evidence, disease state/landscape, and aspirational label. For later life-cycle assets, determine the need for and enrich the SCP (based on wide cross-functional input) with evolving evidence from clinical studies, insights, the Clinical Development Plan and regulatory strategy to ensure teams use accurate, consistent language Ensure the product-level SCP is aligned to the broader Therapeutic Area, tumor and/or modality scientific narrative and that information is pulled through to all scientific communication deliverables Establish and maintain the Scientific Communication Platform (SCP) for products in their TA, including overarching scientific communication objectives. In addition to Therapeutic Area and Asset-specific SCPs, the TA Sci Comms lead is responsible for developing global medical narratives and FAQs around key data disclosures Work closely with clinical/medical teams during data readouts to determine key messages (aligned to the SCP) Collaborate with non-Medical stakeholders (e.g. Scientific Affairs, Corporate Communication, etc.) to ensure consistency of scientific communications for non-medical audiences. Orchestrate OLT (Oncology Leadership Team) informs/reviews of key disclosures. Co-chair medical/sci-comms sub-committee(s) of the GMAT Data Disclosure (Publications): Focus: Drive and deliver on data disclosure plans, including Plain Language Summaries (PLS) and Enhanced Publication Content (EPC) Manage author reviews and preparedness Chair Scientific Publications Committees (SPCs) Work closely with clinical study teams during data readouts to determine publication content Ensure updates to global publication plans occur as needed on a regular basis Support GPTs, Global Medical franchises, and other Pfizer Oncology stakeholders by engaging with the external medical community on publication activities. Serve as a core member of medical/sci-comms sub-committee(s) of the GMAT. Content Focus: Lead above or specific-therapeutic area content strategies, projects, digital initiatives and broad enterprise-wide initiatives to advance content impact throughout the organization across all medical content on externally- and internally-facing medical channels Define and deliver external Global and US medical-to-medical content for Field/HQ/Congresses; congress content, digital medical platforms, and content for newly prioritized medical channels. Ensure updates to global congress content occurs as needed on a regular basis in coordination with key cross-functional stakeholders, including commercial, development and Medical TA teams and platforms. Responsible for ensuring the creation of field medical content is aligned with the needs of the Pfizer Oncology Global Medical TA team and regional/local Medical Affairs. Proactively resolve issues around content creation, combining medical affairs expertise with an understanding of the patient, healthcare professional, legal, regulatory, and organized customer points of view. Define and deliver TA training content with support from Platform training teams when applicable. Serve as a core member of medical/sci-comms sub-committee(s) of the GMAT. Note: while colleagues will typically focus on one of these areas, there is an expectation that if a business need arises, the team member can adapt and support other functional focus areas. QUALIFICATIONS Bachelor's degree with a minimum of 10 years of relevant biopharmaceutical/biotech or agency experience (such as Medical Communications, Medical Affairs or scientific communications within Clinical Development roles). Advanced scientific degree (PhD, PharmD, MS, etc.) preferred Experience developing strategic scientific communications and other scientific content to support scientific exchange, including the use of tools and programs to meet the needs of HCPs. Have a strong understanding of Medical Affairs, including medical strategies, disease areas, and objectives. Ability to quickly build rapport and credibility with key internal and key external stakeholders through strong interpersonal skills; strong matrix leadership Demonstrated ability to translate complex scientific concepts and data into meaningful and digestible communications and foundational tools that can be utilized via multiple channels including at scientific conferences click apply for full job details
12/13/2025
Full time
ROLE SUMMARY Today, Pfizer Oncology has an industry-leading portfolio of 25 approved innovative cancer medicines, including major therapies for metastatic breast cancer, prostate cancer, urothelial carcinoma, and hematologic malignancies. Pfizer's in-line portfolio is focused on four broad, key areas: breast cancer, genitourinary cancer, hematology, and precision medicine, complemented by an extensive pipeline of over 50 programs in clinical development. The Oncology Scientific Communications Director will report to the Team Lead within Pfizer Oncology Medical Strategy Management The Oncology Scientific Communications Director will lead the development and execution of impactful scientific communication strategies for assigned Pfizer medicines and across their tumor area, with a focus on achieving a singular scientific voice anchored to the evidence. The Director will ensure that overall scientific communication and content strategies reflect TA priorities and that tactical execution of medical and scientific communication activities, specifically focused on optimizing the engagement and reach of emerging scientific information within the oncology community, occurs successfully and according to strategy. This role will focus on achieving a singular scientific voice anchored to the evidence, optimizing the engagement, consistency and reach of emerging scientific information within the oncology community. They will be a subject matter expert in one of the three below chosen capabilities: Therapeutic Area (TA) Scientific Communications: ensure asset strategies and messaging are seamlessly integrated into TA-specific plans and materials. The TA Sci Comms lead will also focus on the delivery of foundational resources such as Scientific Communications Platforms (SCPs), Narratives, and FAQs. Data Disclosure (Publications): Collaborate with TA teams and Sci Comms colleagues to drive the publication planning, writing, and dissemination of scientific data from clinical trials and research activities, ensuring a cohesive and impactful publication strategy across the portfolio. Medical Content: Create a wide range of engaging and informative scientific content for diverse channels and audiences, including medical to medical resources, congress and digital platform content. ROLES AND RESPONSIBILITIES The Director will be responsible for the following, with specific responsibilities varying based on the chosen Sci Comms functional focus area (TA, Data Disclosures, or Content). This role may require working across two functional areas for one product/program. General Responsibilities (applicable to all focus areas): Responsible for ensuring strategic input from a broad range of stakeholders (internal and external) is integrated into scientific communications strategic planning to meet the needs of these stakeholders and especially the Oncology Medical TA teams Support Global Product Teams, Global Medical franchises, and other Pfizer Oncology stakeholders in engaging with the external medical community on activities related to key clinical trial data readouts. Ensure alignment of each product's overall scientific content/communications strategy with relevant Pfizer Oncology stakeholders (e.g., partnering with cross-functional Medical Teams, Channel Excellence, Data Analytics, and other key stakeholders to ensure alignment of communication plans with medical priorities and optimize opportunities for broader data dissemination) Act as a strategic thought partner to the TA medical team, providing sci comms functional guidance and subject matter expertise in their designated focus area Leads financial projections and budget management for functional deliverables in addition to managing agencies and off-shore teams (if applicable) Collaborate with International Medical Channel Content team to ensure sci comms deliverables are shared with country medical colleagues for adaptation Have a thorough understanding of therapeutic area assigned, including policy related issues, and the individual inline and pipeline assets across the specific TAs with an ability either to serve as a primary point of contact for accurate, current medical and scientific knowledge or to identify the appropriate Subject Matter Expert within therapeutic area, for internal and external stakeholders and customers. Responsible for building collaborative relationships with relevant partners in and outside of Medical to ensure optimal creation and execution of channel-specific TA medical communications strategies. Stay abreast of US regulations and guidance that impact digital delivery of scientific information to external HCPs TA Communications: Accountable for strategic oversight of TA scientific communication activities and the overarching scientific communications objectives/strategy/narrative, ensuring alignment and excellence in delivery As a core member of the Global Medical Affairs Team (GMAT), responsible for identifying the need for and establishing the Scientific Communications Platform (SCP) for TA products early in development based on target profile, clinical evidence, disease state/landscape, and aspirational label. For later life-cycle assets, determine the need for and enrich the SCP (based on wide cross-functional input) with evolving evidence from clinical studies, insights, the Clinical Development Plan and regulatory strategy to ensure teams use accurate, consistent language Ensure the product-level SCP is aligned to the broader Therapeutic Area, tumor and/or modality scientific narrative and that information is pulled through to all scientific communication deliverables Establish and maintain the Scientific Communication Platform (SCP) for products in their TA, including overarching scientific communication objectives. In addition to Therapeutic Area and Asset-specific SCPs, the TA Sci Comms lead is responsible for developing global medical narratives and FAQs around key data disclosures Work closely with clinical/medical teams during data readouts to determine key messages (aligned to the SCP) Collaborate with non-Medical stakeholders (e.g. Scientific Affairs, Corporate Communication, etc.) to ensure consistency of scientific communications for non-medical audiences. Orchestrate OLT (Oncology Leadership Team) informs/reviews of key disclosures. Co-chair medical/sci-comms sub-committee(s) of the GMAT Data Disclosure (Publications): Focus: Drive and deliver on data disclosure plans, including Plain Language Summaries (PLS) and Enhanced Publication Content (EPC) Manage author reviews and preparedness Chair Scientific Publications Committees (SPCs) Work closely with clinical study teams during data readouts to determine publication content Ensure updates to global publication plans occur as needed on a regular basis Support GPTs, Global Medical franchises, and other Pfizer Oncology stakeholders by engaging with the external medical community on publication activities. Serve as a core member of medical/sci-comms sub-committee(s) of the GMAT. Content Focus: Lead above or specific-therapeutic area content strategies, projects, digital initiatives and broad enterprise-wide initiatives to advance content impact throughout the organization across all medical content on externally- and internally-facing medical channels Define and deliver external Global and US medical-to-medical content for Field/HQ/Congresses; congress content, digital medical platforms, and content for newly prioritized medical channels. Ensure updates to global congress content occurs as needed on a regular basis in coordination with key cross-functional stakeholders, including commercial, development and Medical TA teams and platforms. Responsible for ensuring the creation of field medical content is aligned with the needs of the Pfizer Oncology Global Medical TA team and regional/local Medical Affairs. Proactively resolve issues around content creation, combining medical affairs expertise with an understanding of the patient, healthcare professional, legal, regulatory, and organized customer points of view. Define and deliver TA training content with support from Platform training teams when applicable. Serve as a core member of medical/sci-comms sub-committee(s) of the GMAT. Note: while colleagues will typically focus on one of these areas, there is an expectation that if a business need arises, the team member can adapt and support other functional focus areas. QUALIFICATIONS Bachelor's degree with a minimum of 10 years of relevant biopharmaceutical/biotech or agency experience (such as Medical Communications, Medical Affairs or scientific communications within Clinical Development roles). Advanced scientific degree (PhD, PharmD, MS, etc.) preferred Experience developing strategic scientific communications and other scientific content to support scientific exchange, including the use of tools and programs to meet the needs of HCPs. Have a strong understanding of Medical Affairs, including medical strategies, disease areas, and objectives. Ability to quickly build rapport and credibility with key internal and key external stakeholders through strong interpersonal skills; strong matrix leadership Demonstrated ability to translate complex scientific concepts and data into meaningful and digestible communications and foundational tools that can be utilized via multiple channels including at scientific conferences click apply for full job details
Why USAA? At USAA, our mission is to empower our members to achieve financial security through highly competitive products, exceptional service and trusted advice. We seek to be the choice for the military community and their families. Embrace a fulfilling career at USAA, where our core values - honesty, integrity, loyalty and service - define how we treat each other and our members. Be part of what truly makes us special and impactful. The Opportunity We're building something new-and we're looking for bold, creative, and strategic talent to help shape it. USAA's Corporate Affairs team is growing as part of an exciting transformation to strengthen how we engage with our members and each other in service of our mission. Whether you're a strategic business partner or a creative storyteller, join us to forge smarter connections, deeper partnerships, and stronger outcomes. Together, we're enhancing how we serve the military community and their families-making every interaction more meaningful. As a strategic Account Manager supporting USAA - you'll lead the development and delivery of integrated communications strategies that inform, engage and inspire. With a strong understanding of the financial services landscape, your part strategist, part storyteller and part project manager - deeply attuned to the business, its people, and the channels that matter. You'll collaborate across Corporate Affairs and act as a connector-bringing strategic thinking, content savvy and rigor to every engagement. You'll bring the ability to quickly understand business goals, navigate functional priorities and translate complex strategies into clear, actionable communications. We offer a flexible work environment that requires an individual to be in the office 4 days per week. This position can be based in one of the following locations: San Antonio, TX or Plano, TX. Relocation assistance is not available for this position. What you'll do: Provides regular counsel and insight to senior management, company leaders, subject-matter experts, and unit staff to develop highly complex effective communication strategies and tactics in support of enterprise strategic initiatives. Prioritizes highly complex communication projects and ensures they support enterprise plans for employee, member, and public initiatives. Serves as a key influencer and integrator of strategic objectives across the enterprise. Creates strategies that employ communications tactics such as press outreach, online advocacy, social networking internal and external social channels, leadership, and other internal and external communication channels, and publications. Measures the effectiveness of communications strategies to ensure objectives are met. Develops and implements highly complex communications plans in support of business objectives and collaborates with colleagues to support positive business outcomes, protect and enhance USAA's reputation, and engage the company's workforce. Develops, manages and executes effective messaging, collateral, processes and strategies in support of business initiatives, craft key messaging for use with federal and local regulators. Partners with various teams within the Marketing & Communications Organization (e.g. Social Business, Content Strategy & Development) and with key enterprise partners in the development of collateral to be used across all mediums, including print, web, email, video, and social media to help deliver the messages on the identified channels. Maintains a command of USAA strategies and possesses in-depth knowledge of financial services industry issues and trends, and actively seeking to link those issues to ongoing or emerging employee, member and/or public communications opportunities. In support of public affairs, leads and/or partners in the development and implementation of all communications to include crisis management, legislative, regulatory and litigation communications. Manages message development and builds relationships with third-party groups. Develops and manages grassroots communications with influential groups. Develops relationships with the news media to leverage USAA's reputation. In support of social media, partners with the Social Business team to plans, directs, and executes USAA's social media strategy to protect, sustain, and enhance USAA's reputation. Develops and mentors junior team members. Ensures risks associated with business activities are effectively identified, measured, monitored, and controlled in accordance with risk and compliance policies and procedures. What you have: Bachelor's Degree in Communications, Journalism, Marketing, or a related degree required OR 4 additional years of related experience beyond the minimum required may be substituted in lieu of a degree. 8 or more years of progressively responsible experience in internal and/or external communications (including employee communications), preferably within the financial services industry to include media relations experience working with media outlets at national, regional or local levels. Subject Matter Expert writing and editing skills and excellent verbal communication skills. Subject-matter-expert knowledge of the function/discipline and demonstrated application of knowledge, skills and abilities towards work products required. Subject-matter-expert level in communication industry practices and emerging trends required. Experience in translating business objectives into integrated communication strategies and tactics that drive business performance. Project management and collaboration experience including managing cross-functional projects from inception to completion. What sets you apart: Experience in Financial Service communications and/or working within an agency model in an account management or producer role Strong Project Management skills and experience in PM Tools such as Workfront and/or Asana Enjoys collaborating cross-functionally to enhance business outcomes. Experience in video, radio & photography production. Experience shaping creative communications that are pointed at solving a business challenge. US military experience through military service or a military spouse/domestic partner Compensation range: The salary range for this position is: $127,310 - $243,340. USAA does not provide visa sponsorship for this role. Please do not apply for this role if at any time (now or in the future) you will need immigration support (i.e., H-1B, TN, STEM OPT Training Plans, etc.). Compensation: USAA has an effective process for assessing market data and establishing ranges to ensure we remain competitive. You are paid within the salary range based on your experience and market data of the position. The actual salary for this role may vary by location. Employees may be eligible for pay incentives based on overall corporate and individual performance and at the discretion of the USAA Board of Directors. The above description reflects the details considered necessary to describe the principal functions of the job and should not be construed as a detailed description of all the work requirements that may be performed in the job. Benefits: At USAA our employees enjoy best-in-class benefits to support their physical, financial, and emotional wellness. These benefits include comprehensive medical, dental and vision plans, 401(k), pension, life insurance, parental benefits, adoption assistance, paid time off program with paid holidays plus 16 paid volunteer hours, and various wellness programs. Additionally, our career path planning and continuing education assists employees with their professional goals. For more details on our outstanding benefits, visit our benefits page on Applications for this position are accepted on an ongoing basis, this posting will remain open until the position is filled. Thus, interested candidates are encouraged to apply the same day they view this posting. USAA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
12/10/2025
Full time
Why USAA? At USAA, our mission is to empower our members to achieve financial security through highly competitive products, exceptional service and trusted advice. We seek to be the choice for the military community and their families. Embrace a fulfilling career at USAA, where our core values - honesty, integrity, loyalty and service - define how we treat each other and our members. Be part of what truly makes us special and impactful. The Opportunity We're building something new-and we're looking for bold, creative, and strategic talent to help shape it. USAA's Corporate Affairs team is growing as part of an exciting transformation to strengthen how we engage with our members and each other in service of our mission. Whether you're a strategic business partner or a creative storyteller, join us to forge smarter connections, deeper partnerships, and stronger outcomes. Together, we're enhancing how we serve the military community and their families-making every interaction more meaningful. As a strategic Account Manager supporting USAA - you'll lead the development and delivery of integrated communications strategies that inform, engage and inspire. With a strong understanding of the financial services landscape, your part strategist, part storyteller and part project manager - deeply attuned to the business, its people, and the channels that matter. You'll collaborate across Corporate Affairs and act as a connector-bringing strategic thinking, content savvy and rigor to every engagement. You'll bring the ability to quickly understand business goals, navigate functional priorities and translate complex strategies into clear, actionable communications. We offer a flexible work environment that requires an individual to be in the office 4 days per week. This position can be based in one of the following locations: San Antonio, TX or Plano, TX. Relocation assistance is not available for this position. What you'll do: Provides regular counsel and insight to senior management, company leaders, subject-matter experts, and unit staff to develop highly complex effective communication strategies and tactics in support of enterprise strategic initiatives. Prioritizes highly complex communication projects and ensures they support enterprise plans for employee, member, and public initiatives. Serves as a key influencer and integrator of strategic objectives across the enterprise. Creates strategies that employ communications tactics such as press outreach, online advocacy, social networking internal and external social channels, leadership, and other internal and external communication channels, and publications. Measures the effectiveness of communications strategies to ensure objectives are met. Develops and implements highly complex communications plans in support of business objectives and collaborates with colleagues to support positive business outcomes, protect and enhance USAA's reputation, and engage the company's workforce. Develops, manages and executes effective messaging, collateral, processes and strategies in support of business initiatives, craft key messaging for use with federal and local regulators. Partners with various teams within the Marketing & Communications Organization (e.g. Social Business, Content Strategy & Development) and with key enterprise partners in the development of collateral to be used across all mediums, including print, web, email, video, and social media to help deliver the messages on the identified channels. Maintains a command of USAA strategies and possesses in-depth knowledge of financial services industry issues and trends, and actively seeking to link those issues to ongoing or emerging employee, member and/or public communications opportunities. In support of public affairs, leads and/or partners in the development and implementation of all communications to include crisis management, legislative, regulatory and litigation communications. Manages message development and builds relationships with third-party groups. Develops and manages grassroots communications with influential groups. Develops relationships with the news media to leverage USAA's reputation. In support of social media, partners with the Social Business team to plans, directs, and executes USAA's social media strategy to protect, sustain, and enhance USAA's reputation. Develops and mentors junior team members. Ensures risks associated with business activities are effectively identified, measured, monitored, and controlled in accordance with risk and compliance policies and procedures. What you have: Bachelor's Degree in Communications, Journalism, Marketing, or a related degree required OR 4 additional years of related experience beyond the minimum required may be substituted in lieu of a degree. 8 or more years of progressively responsible experience in internal and/or external communications (including employee communications), preferably within the financial services industry to include media relations experience working with media outlets at national, regional or local levels. Subject Matter Expert writing and editing skills and excellent verbal communication skills. Subject-matter-expert knowledge of the function/discipline and demonstrated application of knowledge, skills and abilities towards work products required. Subject-matter-expert level in communication industry practices and emerging trends required. Experience in translating business objectives into integrated communication strategies and tactics that drive business performance. Project management and collaboration experience including managing cross-functional projects from inception to completion. What sets you apart: Experience in Financial Service communications and/or working within an agency model in an account management or producer role Strong Project Management skills and experience in PM Tools such as Workfront and/or Asana Enjoys collaborating cross-functionally to enhance business outcomes. Experience in video, radio & photography production. Experience shaping creative communications that are pointed at solving a business challenge. US military experience through military service or a military spouse/domestic partner Compensation range: The salary range for this position is: $127,310 - $243,340. USAA does not provide visa sponsorship for this role. Please do not apply for this role if at any time (now or in the future) you will need immigration support (i.e., H-1B, TN, STEM OPT Training Plans, etc.). Compensation: USAA has an effective process for assessing market data and establishing ranges to ensure we remain competitive. You are paid within the salary range based on your experience and market data of the position. The actual salary for this role may vary by location. Employees may be eligible for pay incentives based on overall corporate and individual performance and at the discretion of the USAA Board of Directors. The above description reflects the details considered necessary to describe the principal functions of the job and should not be construed as a detailed description of all the work requirements that may be performed in the job. Benefits: At USAA our employees enjoy best-in-class benefits to support their physical, financial, and emotional wellness. These benefits include comprehensive medical, dental and vision plans, 401(k), pension, life insurance, parental benefits, adoption assistance, paid time off program with paid holidays plus 16 paid volunteer hours, and various wellness programs. Additionally, our career path planning and continuing education assists employees with their professional goals. For more details on our outstanding benefits, visit our benefits page on Applications for this position are accepted on an ongoing basis, this posting will remain open until the position is filled. Thus, interested candidates are encouraged to apply the same day they view this posting. USAA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Why USAA? At USAA, our mission is to empower our members to achieve financial security through highly competitive products, exceptional service and trusted advice. We seek to be the choice for the military community and their families. Embrace a fulfilling career at USAA, where our core values - honesty, integrity, loyalty and service - define how we treat each other and our members. Be part of what truly makes us special and impactful. The Opportunity We're building something new-and we're looking for bold, creative, and strategic talent to help shape it. USAA's Corporate Affairs team is growing as part of an exciting transformation to strengthen how we engage with our members and each other in service of our mission. Whether you're a strategic business partner or a creative storyteller, join us to forge smarter connections, deeper partnerships, and stronger outcomes. Together, we're enhancing how we serve the military community and their families-making every interaction more meaningful. As a dedicated Corporate Affairs Business Partner at the Lead level, you will serve as a strategic advisor, bridging Corporate Affairs with the Property & Casualty and Life Insurance business lines at USAA. You will counsel internal clients on effective stakeholder engagement strategies to help them achieve their goals. You will also be responsible for developing and executing corporate impact strategies that advance enterprise priorities, protect and elevate the company's reputation, and connect employees and stakeholders to USAA's mission We offer a flexible work environment that requires an individual to be in the office 4 days per week. This position will be based in the San Antonio, TX office. Relocation assistance is not available for this position. What you'll do: Advises business leadership on communications, reputation management, corporate impact, and stakeholder engagement strategies, ensuring Corporate Affairs enables enterprise strategy, drives growth, and mitigates risk. Develops and executes comprehensive corporate affairs plans aligned with enterprise strategic plans and business objectives. Leads the development and implementation of corporate affairs strategies that align with overall enterprise strategy and business objectives for both internal and external audiences. This includes proactively identifying and managing crises, potential reputation risks, and opportunities. Employs data-driven analysis to develop and implement proactive strategies for mitigating potential business challenges and external risks. Maintains an in-depth understanding of the external market, business strategy, and corporate affairs function. Cultivates strong relationships with internal partners, highlighting the contributions and measurable results of corporate affairs efforts. Uses this data to adapt and improve strategic plans to better support business objectives. Partners with content studio team members to deliver high quality communications for collective execution in support of corporate strategy and business goals. Provides mentorship and training to team members, supporting their development. Ensures risks associated with business activities are effectively identified, measured, monitored, and controlled in accordance with risk and compliance policies and procedures. What you have: Bachelor's Degree required; OR 4 years of related experience (in addition to the minimum years of experience required) may be substituted in lieu of degree. 8 years of experience in corporate communications, public affairs, general business consulting, or related work experience Demonstrated success advising senior leaders and navigating complex organizations. Deep understanding of business drivers and the ability to align communications and social impact efforts to enterprise strategy. Comprehensive knowledge of the financial services and insurance industries and regulatory landscape. Experience developing and implementing communications strategies that align with overall business objectives and drive measurable results. Demonstrated ability to assess and make decisions of a complex nature that align to enterprise and/or business objectives and the ability to identify and resolve issues effectively. Demonstrates an advanced understanding of target audiences, uses strong skills in editing and writing style to impact significant change through written communication. Adapts communications style across diverse audiences and channels. Experience leading cross-functional teams or projects. What sets you apart: Experience supporting P&C or Life Insurance businesses, preferably both Business acumen, particularly around corporate financials Communications agency or management consulting experience Executive presence, a persuasive style and sound judgement US military experience through military service or a military spouse/domestic partner Compensation range: The salary range for this position is: $127,310 - $229,160. USAA does not provide visa sponsorship for this role. Please do not apply for this role if at any time (now or in the future) you will need immigration support (i.e., H-1B, TN, STEM OPT Training Plans, etc.). Compensation: USAA has an effective process for assessing market data and establishing ranges to ensure we remain competitive. You are paid within the salary range based on your experience and market data of the position. The actual salary for this role may vary by location. Employees may be eligible for pay incentives based on overall corporate and individual performance and at the discretion of the USAA Board of Directors. The above description reflects the details considered necessary to describe the principal functions of the job and should not be construed as a detailed description of all the work requirements that may be performed in the job. Benefits: At USAA our employees enjoy best-in-class benefits to support their physical, financial, and emotional wellness. These benefits include comprehensive medical, dental and vision plans, 401(k), pension, life insurance, parental benefits, adoption assistance, paid time off program with paid holidays plus 16 paid volunteer hours, and various wellness programs. Additionally, our career path planning and continuing education assists employees with their professional goals. For more details on our outstanding benefits, visit our benefits page on Applications for this position are accepted on an ongoing basis, this posting will remain open until the position is filled. Thus, interested candidates are encouraged to apply the same day they view this posting. USAA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
12/08/2025
Full time
Why USAA? At USAA, our mission is to empower our members to achieve financial security through highly competitive products, exceptional service and trusted advice. We seek to be the choice for the military community and their families. Embrace a fulfilling career at USAA, where our core values - honesty, integrity, loyalty and service - define how we treat each other and our members. Be part of what truly makes us special and impactful. The Opportunity We're building something new-and we're looking for bold, creative, and strategic talent to help shape it. USAA's Corporate Affairs team is growing as part of an exciting transformation to strengthen how we engage with our members and each other in service of our mission. Whether you're a strategic business partner or a creative storyteller, join us to forge smarter connections, deeper partnerships, and stronger outcomes. Together, we're enhancing how we serve the military community and their families-making every interaction more meaningful. As a dedicated Corporate Affairs Business Partner at the Lead level, you will serve as a strategic advisor, bridging Corporate Affairs with the Property & Casualty and Life Insurance business lines at USAA. You will counsel internal clients on effective stakeholder engagement strategies to help them achieve their goals. You will also be responsible for developing and executing corporate impact strategies that advance enterprise priorities, protect and elevate the company's reputation, and connect employees and stakeholders to USAA's mission We offer a flexible work environment that requires an individual to be in the office 4 days per week. This position will be based in the San Antonio, TX office. Relocation assistance is not available for this position. What you'll do: Advises business leadership on communications, reputation management, corporate impact, and stakeholder engagement strategies, ensuring Corporate Affairs enables enterprise strategy, drives growth, and mitigates risk. Develops and executes comprehensive corporate affairs plans aligned with enterprise strategic plans and business objectives. Leads the development and implementation of corporate affairs strategies that align with overall enterprise strategy and business objectives for both internal and external audiences. This includes proactively identifying and managing crises, potential reputation risks, and opportunities. Employs data-driven analysis to develop and implement proactive strategies for mitigating potential business challenges and external risks. Maintains an in-depth understanding of the external market, business strategy, and corporate affairs function. Cultivates strong relationships with internal partners, highlighting the contributions and measurable results of corporate affairs efforts. Uses this data to adapt and improve strategic plans to better support business objectives. Partners with content studio team members to deliver high quality communications for collective execution in support of corporate strategy and business goals. Provides mentorship and training to team members, supporting their development. Ensures risks associated with business activities are effectively identified, measured, monitored, and controlled in accordance with risk and compliance policies and procedures. What you have: Bachelor's Degree required; OR 4 years of related experience (in addition to the minimum years of experience required) may be substituted in lieu of degree. 8 years of experience in corporate communications, public affairs, general business consulting, or related work experience Demonstrated success advising senior leaders and navigating complex organizations. Deep understanding of business drivers and the ability to align communications and social impact efforts to enterprise strategy. Comprehensive knowledge of the financial services and insurance industries and regulatory landscape. Experience developing and implementing communications strategies that align with overall business objectives and drive measurable results. Demonstrated ability to assess and make decisions of a complex nature that align to enterprise and/or business objectives and the ability to identify and resolve issues effectively. Demonstrates an advanced understanding of target audiences, uses strong skills in editing and writing style to impact significant change through written communication. Adapts communications style across diverse audiences and channels. Experience leading cross-functional teams or projects. What sets you apart: Experience supporting P&C or Life Insurance businesses, preferably both Business acumen, particularly around corporate financials Communications agency or management consulting experience Executive presence, a persuasive style and sound judgement US military experience through military service or a military spouse/domestic partner Compensation range: The salary range for this position is: $127,310 - $229,160. USAA does not provide visa sponsorship for this role. Please do not apply for this role if at any time (now or in the future) you will need immigration support (i.e., H-1B, TN, STEM OPT Training Plans, etc.). Compensation: USAA has an effective process for assessing market data and establishing ranges to ensure we remain competitive. You are paid within the salary range based on your experience and market data of the position. The actual salary for this role may vary by location. Employees may be eligible for pay incentives based on overall corporate and individual performance and at the discretion of the USAA Board of Directors. The above description reflects the details considered necessary to describe the principal functions of the job and should not be construed as a detailed description of all the work requirements that may be performed in the job. Benefits: At USAA our employees enjoy best-in-class benefits to support their physical, financial, and emotional wellness. These benefits include comprehensive medical, dental and vision plans, 401(k), pension, life insurance, parental benefits, adoption assistance, paid time off program with paid holidays plus 16 paid volunteer hours, and various wellness programs. Additionally, our career path planning and continuing education assists employees with their professional goals. For more details on our outstanding benefits, visit our benefits page on Applications for this position are accepted on an ongoing basis, this posting will remain open until the position is filled. Thus, interested candidates are encouraged to apply the same day they view this posting. USAA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Why USAA? At USAA, our mission is to empower our members to achieve financial security through highly competitive products, exceptional service and trusted advice. We seek to be the choice for the military community and their families. Embrace a fulfilling career at USAA, where our core values - honesty, integrity, loyalty and service - define how we treat each other and our members. Be part of what truly makes us special and impactful. The Opportunity We're building something new-and we're looking for bold, creative, and strategic talent to help shape it. USAA's Corporate Affairs team is growing as part of an exciting transformation to strengthen how we engage with our members and each other in service of our mission. Whether you're a strategic business partner or a creative storyteller, join us to forge smarter connections, deeper partnerships, and stronger outcomes. Together, we're enhancing how we serve the military community and their families-making every interaction more meaningful. As a strategic Account Manager supporting USAA - you'll lead the development and delivery of integrated communications strategies that inform, engage and inspire. With a strong understanding of the financial services landscape, your part strategist, part storyteller and part project manager - deeply attuned to the business, its people, and the channels that matter. You'll collaborate across Corporate Affairs and act as a connector-bringing strategic thinking, content savvy and rigor to every engagement. You'll bring the ability to quickly understand business goals, navigate functional priorities and translate complex strategies into clear, actionable communications. We offer a flexible work environment that requires an individual to be in the office 4 days per week. This position can be based in one of the following locations: San Antonio, TX or Plano, TX. Relocation assistance is not available for this position. What you'll do: Provides regular counsel and insight to senior management, company leaders, subject-matter experts, and unit staff to develop highly complex effective communication strategies and tactics in support of enterprise strategic initiatives. Prioritizes highly complex communication projects and ensures they support enterprise plans for employee, member, and public initiatives. Serves as a key influencer and integrator of strategic objectives across the enterprise. Creates strategies that employ communications tactics such as press outreach, online advocacy, social networking internal and external social channels, leadership, and other internal and external communication channels, and publications. Measures the effectiveness of communications strategies to ensure objectives are met. Develops and implements highly complex communications plans in support of business objectives and collaborates with colleagues to support positive business outcomes, protect and enhance USAA's reputation, and engage the company's workforce. Develops, manages and executes effective messaging, collateral, processes and strategies in support of business initiatives, craft key messaging for use with federal and local regulators. Partners with various teams within the Marketing & Communications Organization (e.g. Social Business, Content Strategy & Development) and with key enterprise partners in the development of collateral to be used across all mediums, including print, web, email, video, and social media to help deliver the messages on the identified channels. Maintains a command of USAA strategies and possesses in-depth knowledge of financial services industry issues and trends, and actively seeking to link those issues to ongoing or emerging employee, member and/or public communications opportunities. In support of public affairs, leads and/or partners in the development and implementation of all communications to include crisis management, legislative, regulatory and litigation communications. Manages message development and builds relationships with third-party groups. Develops and manages grassroots communications with influential groups. Develops relationships with the news media to leverage USAA's reputation. In support of social media, partners with the Social Business team to plans, directs, and executes USAA's social media strategy to protect, sustain, and enhance USAA's reputation. Develops and mentors junior team members. Ensures risks associated with business activities are effectively identified, measured, monitored, and controlled in accordance with risk and compliance policies and procedures. What you have: Bachelor's Degree in Communications, Journalism, Marketing, or a related degree required OR 4 additional years of related experience beyond the minimum required may be substituted in lieu of a degree. 8 or more years of progressively responsible experience in internal and/or external communications (including employee communications), preferably within the financial services industry to include media relations experience working with media outlets at national, regional or local levels. Subject Matter Expert writing and editing skills and excellent verbal communication skills. Subject-matter-expert knowledge of the function/discipline and demonstrated application of knowledge, skills and abilities towards work products required. Subject-matter-expert level in communication industry practices and emerging trends required. Experience in translating business objectives into integrated communication strategies and tactics that drive business performance. Project management and collaboration experience including managing cross-functional projects from inception to completion. What sets you apart: Experience in Financial Service communications and/or working within an agency model in an account management or producer role Strong Project Management skills and experience in PM Tools such as Workfront and/or Asana Enjoys collaborating cross-functionally to enhance business outcomes. Experience in video, radio & photography production. Experience shaping creative communications that are pointed at solving a business challenge. US military experience through military service or a military spouse/domestic partner Compensation range: The salary range for this position is: $127,310 - $243,340. USAA does not provide visa sponsorship for this role. Please do not apply for this role if at any time (now or in the future) you will need immigration support (i.e., H-1B, TN, STEM OPT Training Plans, etc.). Compensation: USAA has an effective process for assessing market data and establishing ranges to ensure we remain competitive. You are paid within the salary range based on your experience and market data of the position. The actual salary for this role may vary by location. Employees may be eligible for pay incentives based on overall corporate and individual performance and at the discretion of the USAA Board of Directors. The above description reflects the details considered necessary to describe the principal functions of the job and should not be construed as a detailed description of all the work requirements that may be performed in the job. Benefits: At USAA our employees enjoy best-in-class benefits to support their physical, financial, and emotional wellness. These benefits include comprehensive medical, dental and vision plans, 401(k), pension, life insurance, parental benefits, adoption assistance, paid time off program with paid holidays plus 16 paid volunteer hours, and various wellness programs. Additionally, our career path planning and continuing education assists employees with their professional goals. For more details on our outstanding benefits, visit our benefits page on Applications for this position are accepted on an ongoing basis, this posting will remain open until the position is filled. Thus, interested candidates are encouraged to apply the same day they view this posting. USAA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
12/04/2025
Full time
Why USAA? At USAA, our mission is to empower our members to achieve financial security through highly competitive products, exceptional service and trusted advice. We seek to be the choice for the military community and their families. Embrace a fulfilling career at USAA, where our core values - honesty, integrity, loyalty and service - define how we treat each other and our members. Be part of what truly makes us special and impactful. The Opportunity We're building something new-and we're looking for bold, creative, and strategic talent to help shape it. USAA's Corporate Affairs team is growing as part of an exciting transformation to strengthen how we engage with our members and each other in service of our mission. Whether you're a strategic business partner or a creative storyteller, join us to forge smarter connections, deeper partnerships, and stronger outcomes. Together, we're enhancing how we serve the military community and their families-making every interaction more meaningful. As a strategic Account Manager supporting USAA - you'll lead the development and delivery of integrated communications strategies that inform, engage and inspire. With a strong understanding of the financial services landscape, your part strategist, part storyteller and part project manager - deeply attuned to the business, its people, and the channels that matter. You'll collaborate across Corporate Affairs and act as a connector-bringing strategic thinking, content savvy and rigor to every engagement. You'll bring the ability to quickly understand business goals, navigate functional priorities and translate complex strategies into clear, actionable communications. We offer a flexible work environment that requires an individual to be in the office 4 days per week. This position can be based in one of the following locations: San Antonio, TX or Plano, TX. Relocation assistance is not available for this position. What you'll do: Provides regular counsel and insight to senior management, company leaders, subject-matter experts, and unit staff to develop highly complex effective communication strategies and tactics in support of enterprise strategic initiatives. Prioritizes highly complex communication projects and ensures they support enterprise plans for employee, member, and public initiatives. Serves as a key influencer and integrator of strategic objectives across the enterprise. Creates strategies that employ communications tactics such as press outreach, online advocacy, social networking internal and external social channels, leadership, and other internal and external communication channels, and publications. Measures the effectiveness of communications strategies to ensure objectives are met. Develops and implements highly complex communications plans in support of business objectives and collaborates with colleagues to support positive business outcomes, protect and enhance USAA's reputation, and engage the company's workforce. Develops, manages and executes effective messaging, collateral, processes and strategies in support of business initiatives, craft key messaging for use with federal and local regulators. Partners with various teams within the Marketing & Communications Organization (e.g. Social Business, Content Strategy & Development) and with key enterprise partners in the development of collateral to be used across all mediums, including print, web, email, video, and social media to help deliver the messages on the identified channels. Maintains a command of USAA strategies and possesses in-depth knowledge of financial services industry issues and trends, and actively seeking to link those issues to ongoing or emerging employee, member and/or public communications opportunities. In support of public affairs, leads and/or partners in the development and implementation of all communications to include crisis management, legislative, regulatory and litigation communications. Manages message development and builds relationships with third-party groups. Develops and manages grassroots communications with influential groups. Develops relationships with the news media to leverage USAA's reputation. In support of social media, partners with the Social Business team to plans, directs, and executes USAA's social media strategy to protect, sustain, and enhance USAA's reputation. Develops and mentors junior team members. Ensures risks associated with business activities are effectively identified, measured, monitored, and controlled in accordance with risk and compliance policies and procedures. What you have: Bachelor's Degree in Communications, Journalism, Marketing, or a related degree required OR 4 additional years of related experience beyond the minimum required may be substituted in lieu of a degree. 8 or more years of progressively responsible experience in internal and/or external communications (including employee communications), preferably within the financial services industry to include media relations experience working with media outlets at national, regional or local levels. Subject Matter Expert writing and editing skills and excellent verbal communication skills. Subject-matter-expert knowledge of the function/discipline and demonstrated application of knowledge, skills and abilities towards work products required. Subject-matter-expert level in communication industry practices and emerging trends required. Experience in translating business objectives into integrated communication strategies and tactics that drive business performance. Project management and collaboration experience including managing cross-functional projects from inception to completion. What sets you apart: Experience in Financial Service communications and/or working within an agency model in an account management or producer role Strong Project Management skills and experience in PM Tools such as Workfront and/or Asana Enjoys collaborating cross-functionally to enhance business outcomes. Experience in video, radio & photography production. Experience shaping creative communications that are pointed at solving a business challenge. US military experience through military service or a military spouse/domestic partner Compensation range: The salary range for this position is: $127,310 - $243,340. USAA does not provide visa sponsorship for this role. Please do not apply for this role if at any time (now or in the future) you will need immigration support (i.e., H-1B, TN, STEM OPT Training Plans, etc.). Compensation: USAA has an effective process for assessing market data and establishing ranges to ensure we remain competitive. You are paid within the salary range based on your experience and market data of the position. The actual salary for this role may vary by location. Employees may be eligible for pay incentives based on overall corporate and individual performance and at the discretion of the USAA Board of Directors. The above description reflects the details considered necessary to describe the principal functions of the job and should not be construed as a detailed description of all the work requirements that may be performed in the job. Benefits: At USAA our employees enjoy best-in-class benefits to support their physical, financial, and emotional wellness. These benefits include comprehensive medical, dental and vision plans, 401(k), pension, life insurance, parental benefits, adoption assistance, paid time off program with paid holidays plus 16 paid volunteer hours, and various wellness programs. Additionally, our career path planning and continuing education assists employees with their professional goals. For more details on our outstanding benefits, visit our benefits page on Applications for this position are accepted on an ongoing basis, this posting will remain open until the position is filled. Thus, interested candidates are encouraged to apply the same day they view this posting. USAA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Description: The Company: Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (CTI-1601), is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich's ataxia. Friedreich's ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality. We have assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience. Our management team, employees, and consultants have significant expertise in discovery, non-clinical and clinical development, regulatory affairs, manufacturing and CMC. Our company's strategy is to become a leader in the treatment of rare diseases by leveraging our cell-penetrating technology platform and applying our team's know-how to the development of Nomlabofusp and our pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success. Position Summary We are seeking an experienced and detail-oriented Director to lead all aspects of Trial Master File (TMF) management across all studies. This role will be fully accountable for the completeness, accuracy, quality, and regulatory compliance of the TMF, ensuring it remains inspection-ready throughout the study lifecycle. This is a hands-on leadership role that requires deep expertise in TMF operations, global regulatory standards, and cross-functional collaboration. The successful candidate will be a strong leader with excellent communication and collaboration skills, preferably with 10-15 years' experience in managing clinical TMFs across the US and EU, and significant vendor management and inspection experience. This role will require a minimum of 2 days a week of onsite presence (or more as business needs require) in our Bala Cynwyd, PA corporate office. Job Responsibilities Trial Master File (TMF) Management Accountable for the company's TMF processes and systems, serving as the business process owner and the system owner for the eTMF. Develop and implement global standards, standard operating procedures, and corresponding controlled documents that are in line with ICH-GCP and all relevant regulatory requirements (e.g., EMA, FDA, MHRA) and industry best practices (e.g., CDISC), including the maintenance and update of the TMF index as changes occur to Larimar and/or vendor SOPs. Develop and implement TMF strategy within Larimar and identify, hire, oversee resources and/or vendors supporting the TMF/eTMF and TMF-related initiatives. Management of the company's eTMF system and support the implementation and integration of any systems or processes that would interface with the eTMF (e.g., Regulatory Information Management (RIM), Quality Management System (QMS), etc.), including data mapping between systems, configuring standard processes and workflows across systems, and managing integrations on an ongoing basis as business needs evolve Establishing governance structure and leading governance meetings with vendors including those supporting clinical studies (e.g., clinical CRO, data management provider) and any vendors supporting the TMF/eTMF including technology providers. Responsible for ensuring that the eTMF system remains in a validated state, and complies with all computer systems validations (CSV) regulations including Annex 11/Part 11 and GAMP. Creating, managing, and executing/approving validation documentation related to eTMF change and release management including IT change control documentation, user acceptance testing (UAT)/performance qualification (PQ) testing documents such as plans and test scripts. Providing study support to cross-functional teams on TMF regulations, processes, and best practices, and supporting document management needs on studies including the development and review of study plans and documents. Supporting internal and external audits and inspections, may include but is not limited to: developing training materials and administering training to inspectors, managing inspector access, supporting teams with document retrieval during audit/inspection, providing system-related support, answering questions around the eTMF system and/or eTMF system procedures, and providing demos or guided-support for the eTMF system, as requested. Clinical/GCP Inspection Readiness As a core member of the inspection readiness team, lead inspection readiness (IR) efforts across clinical study teams and work with cross-functional stakeholders to identify and ensure completion of inspection readiness activities and deliverables within associated project timelines. Contribute to the inspection readiness project deliverables, timelines, and resources. Organize inspection readiness meetings with the relevant study team members, the extended inspection team, and function-specific team IR meetings Contribute to the Development and implementation of tools and templates for the management of inspection readiness activities, including for example, FDA BIMO checklists, project plans, timelines, training materials, study-specific tracking tools (e.g., issue management logs, study document and plan tracking, vendor lists, IT computer systems lists, etc.) Supporting study teams with the execution of IR tasks, as needed. Assist with identifying study issues and working with the clinical study team and Quality to develop CAPAs and strategies to mitigate risks. Supporting study team members with the creation and management of storyboards, NTFs, and project-related documentation, as needed. Supporting gap assessments of clinical procedures and participating in the development and review of clinical SOPs Support the clinical team on all inspection commitments, responses, post-inspection activities and the implementation of corrective and preventative actions. Working with quality and the inspection readiness lead in the development of Laminar onsite and remote inspection management procedures and logistics. Hiring, management, and/or oversight of resources including employees, contractors, consultants, vendors Leading and conducting other projects/tasks as needed to support Larimar inspection readiness activities. Perform related duties as necessary or as assigned Requirements: Qualifications Minimum of 15+ years of relevant industry experience with a Bachelor/MS degree, or 10+ years with a postgraduate degree. Experience managing TMF for global clinical trials including direct vendor oversight Proven, hands-on experience with electronic TMF (eTMF) systems (e.g., Veeva Vault) and related clinical documentation platforms. Deep expertise in global regulatory requirements (e.g., ICH-GCP, FDA, EMA) and well-versed in industry best practices for Trial Master File (TMF) operations. Experience with health authority inspections at the Sponsor level in both front and backroom Strong, practical knowledge of the CDISC TMF Reference Model and its application within operational settings. Broad understanding of end-to-end clinical trial operations and processes, with direct involvement in inspection readiness and compliance activities. Exceptional communication skills-able to clearly convey complex information to diverse stakeholders and foster collaboration across cross-functional teams. Experience managing direct reports Highly skilled in project management, with the ability to oversee multiple concurrent initiatives, establish priorities, and consistently meet critical deadlines. Recognized for strategic problem-solving, organizational acumen, and meticulous attention to detail in a fast-paced environment. Ability and willingness to work onsite at least two days per week, while maintaining strong collaboration in a hybrid work model. Benefits: Larimar Therapeutics offers all employees a competitive salary with frequent market benchmarking, incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy. We are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner. We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live. Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and business needs. The decisions and criteria governing the relationship with all candidates and employees are made in a non-discriminatory manner-without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes. PI94415ea9884f-1581
12/01/2025
Full time
Description: The Company: Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (CTI-1601), is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich's ataxia. Friedreich's ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality. We have assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience. Our management team, employees, and consultants have significant expertise in discovery, non-clinical and clinical development, regulatory affairs, manufacturing and CMC. Our company's strategy is to become a leader in the treatment of rare diseases by leveraging our cell-penetrating technology platform and applying our team's know-how to the development of Nomlabofusp and our pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success. Position Summary We are seeking an experienced and detail-oriented Director to lead all aspects of Trial Master File (TMF) management across all studies. This role will be fully accountable for the completeness, accuracy, quality, and regulatory compliance of the TMF, ensuring it remains inspection-ready throughout the study lifecycle. This is a hands-on leadership role that requires deep expertise in TMF operations, global regulatory standards, and cross-functional collaboration. The successful candidate will be a strong leader with excellent communication and collaboration skills, preferably with 10-15 years' experience in managing clinical TMFs across the US and EU, and significant vendor management and inspection experience. This role will require a minimum of 2 days a week of onsite presence (or more as business needs require) in our Bala Cynwyd, PA corporate office. Job Responsibilities Trial Master File (TMF) Management Accountable for the company's TMF processes and systems, serving as the business process owner and the system owner for the eTMF. Develop and implement global standards, standard operating procedures, and corresponding controlled documents that are in line with ICH-GCP and all relevant regulatory requirements (e.g., EMA, FDA, MHRA) and industry best practices (e.g., CDISC), including the maintenance and update of the TMF index as changes occur to Larimar and/or vendor SOPs. Develop and implement TMF strategy within Larimar and identify, hire, oversee resources and/or vendors supporting the TMF/eTMF and TMF-related initiatives. Management of the company's eTMF system and support the implementation and integration of any systems or processes that would interface with the eTMF (e.g., Regulatory Information Management (RIM), Quality Management System (QMS), etc.), including data mapping between systems, configuring standard processes and workflows across systems, and managing integrations on an ongoing basis as business needs evolve Establishing governance structure and leading governance meetings with vendors including those supporting clinical studies (e.g., clinical CRO, data management provider) and any vendors supporting the TMF/eTMF including technology providers. Responsible for ensuring that the eTMF system remains in a validated state, and complies with all computer systems validations (CSV) regulations including Annex 11/Part 11 and GAMP. Creating, managing, and executing/approving validation documentation related to eTMF change and release management including IT change control documentation, user acceptance testing (UAT)/performance qualification (PQ) testing documents such as plans and test scripts. Providing study support to cross-functional teams on TMF regulations, processes, and best practices, and supporting document management needs on studies including the development and review of study plans and documents. Supporting internal and external audits and inspections, may include but is not limited to: developing training materials and administering training to inspectors, managing inspector access, supporting teams with document retrieval during audit/inspection, providing system-related support, answering questions around the eTMF system and/or eTMF system procedures, and providing demos or guided-support for the eTMF system, as requested. Clinical/GCP Inspection Readiness As a core member of the inspection readiness team, lead inspection readiness (IR) efforts across clinical study teams and work with cross-functional stakeholders to identify and ensure completion of inspection readiness activities and deliverables within associated project timelines. Contribute to the inspection readiness project deliverables, timelines, and resources. Organize inspection readiness meetings with the relevant study team members, the extended inspection team, and function-specific team IR meetings Contribute to the Development and implementation of tools and templates for the management of inspection readiness activities, including for example, FDA BIMO checklists, project plans, timelines, training materials, study-specific tracking tools (e.g., issue management logs, study document and plan tracking, vendor lists, IT computer systems lists, etc.) Supporting study teams with the execution of IR tasks, as needed. Assist with identifying study issues and working with the clinical study team and Quality to develop CAPAs and strategies to mitigate risks. Supporting study team members with the creation and management of storyboards, NTFs, and project-related documentation, as needed. Supporting gap assessments of clinical procedures and participating in the development and review of clinical SOPs Support the clinical team on all inspection commitments, responses, post-inspection activities and the implementation of corrective and preventative actions. Working with quality and the inspection readiness lead in the development of Laminar onsite and remote inspection management procedures and logistics. Hiring, management, and/or oversight of resources including employees, contractors, consultants, vendors Leading and conducting other projects/tasks as needed to support Larimar inspection readiness activities. Perform related duties as necessary or as assigned Requirements: Qualifications Minimum of 15+ years of relevant industry experience with a Bachelor/MS degree, or 10+ years with a postgraduate degree. Experience managing TMF for global clinical trials including direct vendor oversight Proven, hands-on experience with electronic TMF (eTMF) systems (e.g., Veeva Vault) and related clinical documentation platforms. Deep expertise in global regulatory requirements (e.g., ICH-GCP, FDA, EMA) and well-versed in industry best practices for Trial Master File (TMF) operations. Experience with health authority inspections at the Sponsor level in both front and backroom Strong, practical knowledge of the CDISC TMF Reference Model and its application within operational settings. Broad understanding of end-to-end clinical trial operations and processes, with direct involvement in inspection readiness and compliance activities. Exceptional communication skills-able to clearly convey complex information to diverse stakeholders and foster collaboration across cross-functional teams. Experience managing direct reports Highly skilled in project management, with the ability to oversee multiple concurrent initiatives, establish priorities, and consistently meet critical deadlines. Recognized for strategic problem-solving, organizational acumen, and meticulous attention to detail in a fast-paced environment. Ability and willingness to work onsite at least two days per week, while maintaining strong collaboration in a hybrid work model. Benefits: Larimar Therapeutics offers all employees a competitive salary with frequent market benchmarking, incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy. We are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner. We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live. Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and business needs. The decisions and criteria governing the relationship with all candidates and employees are made in a non-discriminatory manner-without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes. PI94415ea9884f-1581
