Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio
The Cincinnati Children's Hospital Infectious Diseases Division seeks an MD or MD-PhD faculty member at the Assistant/Associate Professor or Professor level to fill the position of Medical Director of Infection Prevention and Control (IP&C). The successful candidate will lead a nationally recognized program specializing in infection prevention and clinical care focused on improving outcomes for children at Cincinnati Children's Hospital Medical Center (CCHMC). The ideal candidate will divide their effort between patient care and infection prevention activities, including leadership and scholarship in prevention of hospital acquired infections, engagement of internal and external partners including public health authorities, and representing IP&C and CCHMC in public forums. The current IP&C Program consists of a Director and Associate Director with a planned addition of a second Associate Director in the coming year. There are 13 Infection Preventionists covering 670 beds and specialty and primary care ambulatory facilities. The amount of clinical effort for this position is 35-40%, depending upon the individual strengths and career plans of the candidate. The successful candidate will have opportunities to mentor junior faculty and support for pursuing their individual career goals. Academic efforts at CCHMC are supported by outstanding infrastructure and a substantial research endowment administered through the Cincinnati Children's Research Foundation. Applicants must be board-certified or board-eligible in pediatric infectious diseases. CCHMC is a vibrant academic medical center and one of the top children's hospitals in the world, with 670 beds and operations of >$2.3 billion annually. CCHMC is a leading center for solid organ (heart, kidney, liver, lung and small intestine) and hematopoietic stem cell transplantation. Infectious Diseases Division has existing strengths in many areas of basic and clinical research; including in viral pathogenesis, host-microbe interactions, mechanisms of inflammation and tolerance, vaccine development and clinical trials, transplant/immunocompromised infectious diseases, infectious diseases epidemiology and surveillance, infection prevention, and antimicrobial stewardship. Interested candidates should send a letter of interest and curriculum vitae to: Lara Danziger-Isakov, MD, MPH, Professor, Division of Infectious Diseases, Department of Pediatrics c/o Nathan Gohlke, Senior Physician & Faculty Recruiter: . Required: MD or MD-PhD degree in a related scientific or research field Three years related experience in research field and/or lab experience assisting the preparation of data for presentation at scientific meetings (Fellowship in Pediatric Infectious Disease qualifies) American Board of Pediatrics eligibility/certification in Pediatric Infectious Disease Assistant Professor appointment or eligibility required
10/22/2025
Full time
The Cincinnati Children's Hospital Infectious Diseases Division seeks an MD or MD-PhD faculty member at the Assistant/Associate Professor or Professor level to fill the position of Medical Director of Infection Prevention and Control (IP&C). The successful candidate will lead a nationally recognized program specializing in infection prevention and clinical care focused on improving outcomes for children at Cincinnati Children's Hospital Medical Center (CCHMC). The ideal candidate will divide their effort between patient care and infection prevention activities, including leadership and scholarship in prevention of hospital acquired infections, engagement of internal and external partners including public health authorities, and representing IP&C and CCHMC in public forums. The current IP&C Program consists of a Director and Associate Director with a planned addition of a second Associate Director in the coming year. There are 13 Infection Preventionists covering 670 beds and specialty and primary care ambulatory facilities. The amount of clinical effort for this position is 35-40%, depending upon the individual strengths and career plans of the candidate. The successful candidate will have opportunities to mentor junior faculty and support for pursuing their individual career goals. Academic efforts at CCHMC are supported by outstanding infrastructure and a substantial research endowment administered through the Cincinnati Children's Research Foundation. Applicants must be board-certified or board-eligible in pediatric infectious diseases. CCHMC is a vibrant academic medical center and one of the top children's hospitals in the world, with 670 beds and operations of >$2.3 billion annually. CCHMC is a leading center for solid organ (heart, kidney, liver, lung and small intestine) and hematopoietic stem cell transplantation. Infectious Diseases Division has existing strengths in many areas of basic and clinical research; including in viral pathogenesis, host-microbe interactions, mechanisms of inflammation and tolerance, vaccine development and clinical trials, transplant/immunocompromised infectious diseases, infectious diseases epidemiology and surveillance, infection prevention, and antimicrobial stewardship. Interested candidates should send a letter of interest and curriculum vitae to: Lara Danziger-Isakov, MD, MPH, Professor, Division of Infectious Diseases, Department of Pediatrics c/o Nathan Gohlke, Senior Physician & Faculty Recruiter: . Required: MD or MD-PhD degree in a related scientific or research field Three years related experience in research field and/or lab experience assisting the preparation of data for presentation at scientific meetings (Fellowship in Pediatric Infectious Disease qualifies) American Board of Pediatrics eligibility/certification in Pediatric Infectious Disease Assistant Professor appointment or eligibility required
At Genmab, we are dedicated to building extra not ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us! Genmab is looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization. In this role, you will be primarily responsible for the development of global and US regulatory strategies to advance Genmab's portfolio of development pipeline candidate drugs. You will provide strategic input and ensure operational execution of global and US submission activities. You will be responsible for interfacing directly with the US FDA as the primary contact for the company for assigned programs. This position is based in our Princeton, NJ office which requires onsite presence 60% of the time per our hybrid policy. This position will report to the Regulatory Strategy Team Lead. Responsibilities: The key responsibilities of this role will include, but are not limited to: • Act as the US/Global Regulatory Leader (GRL) for assigned project(s) and be responsible for the development, implementation, and maintenance of US/global regulatory strategies at various stages of development (in line with Product Development Plan). • Represent GRA in Compound Development Teams (CDT) to successfully meet project deliverables while adhering to regulatory requirements for programs and products. Lead the Global Regulatory Team (GRT) and Submission Team(s). Participate in Clinical Trial Teams, as required for the assigned project(s). • For approved products, ensure that regulatory strategies throughout life-cycle management are in place and implemented including label improvement, health authority meetings, potential ROW submissions, supplemental BLA submissions, tracking of progress of PMRs and PMCs, etc. This responsibility may involve collaboration with a partner. • Evaluate regulatory risk and recommend mitigation strategies to the cross-functional teams and management. • Lead the strategic development of briefing materials and prepare teams for US/global health authority meetings. • Participate in the development and review of submission documentation to support successful INDs/CTAs as well as marketing applications (e.g., BLAs/MAAs). • Evaluate competitive landscape and various regulatory mechanisms that allow optimization of product development (e.g., orphan drug designation, breakthrough therapy designation, Fast Track, accelerated approval, pediatric plans) and present options and recommendations to expedite the path to market, as applicable. • Collaborate with the Labeling team to develop the Company Core Data Sheet and US Prescribing Information depending on the assigned project(s). • Consult with senior management to develop and communicate regulatory strategies and advice for products and programs. • Interact with the US FDA and global health agencies for assigned project(s). The US/GRL will lead and/or participate in meetings with FDA and other health authorities as appropriate. • Monitor and assess regulatory guidelines, regulations, and current regulatory environment/landscape, and their impact on the development of Genmab products. • Maintain an updated knowledge of regulatory topics and regulations and participate in maintaining and preparing regulatory processes and ways of working. • Build strong relationships with key external stakeholders including regulatory agencies, professional societies, and key opinion leaders, as relevant. • Participate in review of and comment on regulatory guidance as relevant. • As assigned by management, provide regulatory due diligence assessment of licensing/acquisition opportunities. Requirements: • BSc or MSc level degree preferably within the life sciences (PharmD, PhD preferred) • Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) • Prior experience of direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA) • A solid understanding and experience in drug development including early and late development is highly preferred. • A broad knowledge of life-cycle management is highly preferred. • Strong strategic skills including the ability to make complex decisions • Solid knowledge and understanding of global and US regulations and the US pharmaceutical market • Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance • Strong organizational, communication (both oral and written), and time management skills needed to manage multiple ongoing projects/tasks simultaneously. • Must have attention to detail and be able to solve problems with minimal supervision. • Be able to work independently with an ability to drive projects to successful outcomes. • Ability to influence others and resolve conflicts • Highly motivated and self-driven individual who enjoys being challenged. • Unquestionable ethics, professional integrity, and personal values consistent with the Genmab values About You • You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment • You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving • You are a generous collaborator who can work in teams with diverse backgrounds • You are determined to do and be your best and take pride in enabling the best work of others on the team • You are not afraid to grapple with the unknown and be innovative • You have experience working in a fast-growing, dynamic company (or a strong desire to) • You work hard and are not afraid to have a little fun while you do so Locations Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you're in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate. For US based candidates, the proposed salary band for this position is as follows: $190,720.00 $286,080.00 The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. When you join Genmab, you're joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for: 401(k) Plan: 100% match on the first 6% of contributions Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance Voluntary Plans: Critical illness, accident, and hospital indemnity insurance Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses About You You are genuinely passionate about our purpose You bring precision and excellence to all that you do You believe in our rooted-in-science approach to problem-solving You are a generous collaborator who can work in teams with a broad spectrum of backgrounds You take pride in enabling the best work of others on the team You can grapple with the unknown and be innovative You have experience working in a fast-growing, dynamic company (or a strong desire to) You work hard and are not afraid to have a little fun while you do so! Locations Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to innovate. About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences . click apply for full job details
10/01/2025
Full time
At Genmab, we are dedicated to building extra not ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us! Genmab is looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization. In this role, you will be primarily responsible for the development of global and US regulatory strategies to advance Genmab's portfolio of development pipeline candidate drugs. You will provide strategic input and ensure operational execution of global and US submission activities. You will be responsible for interfacing directly with the US FDA as the primary contact for the company for assigned programs. This position is based in our Princeton, NJ office which requires onsite presence 60% of the time per our hybrid policy. This position will report to the Regulatory Strategy Team Lead. Responsibilities: The key responsibilities of this role will include, but are not limited to: • Act as the US/Global Regulatory Leader (GRL) for assigned project(s) and be responsible for the development, implementation, and maintenance of US/global regulatory strategies at various stages of development (in line with Product Development Plan). • Represent GRA in Compound Development Teams (CDT) to successfully meet project deliverables while adhering to regulatory requirements for programs and products. Lead the Global Regulatory Team (GRT) and Submission Team(s). Participate in Clinical Trial Teams, as required for the assigned project(s). • For approved products, ensure that regulatory strategies throughout life-cycle management are in place and implemented including label improvement, health authority meetings, potential ROW submissions, supplemental BLA submissions, tracking of progress of PMRs and PMCs, etc. This responsibility may involve collaboration with a partner. • Evaluate regulatory risk and recommend mitigation strategies to the cross-functional teams and management. • Lead the strategic development of briefing materials and prepare teams for US/global health authority meetings. • Participate in the development and review of submission documentation to support successful INDs/CTAs as well as marketing applications (e.g., BLAs/MAAs). • Evaluate competitive landscape and various regulatory mechanisms that allow optimization of product development (e.g., orphan drug designation, breakthrough therapy designation, Fast Track, accelerated approval, pediatric plans) and present options and recommendations to expedite the path to market, as applicable. • Collaborate with the Labeling team to develop the Company Core Data Sheet and US Prescribing Information depending on the assigned project(s). • Consult with senior management to develop and communicate regulatory strategies and advice for products and programs. • Interact with the US FDA and global health agencies for assigned project(s). The US/GRL will lead and/or participate in meetings with FDA and other health authorities as appropriate. • Monitor and assess regulatory guidelines, regulations, and current regulatory environment/landscape, and their impact on the development of Genmab products. • Maintain an updated knowledge of regulatory topics and regulations and participate in maintaining and preparing regulatory processes and ways of working. • Build strong relationships with key external stakeholders including regulatory agencies, professional societies, and key opinion leaders, as relevant. • Participate in review of and comment on regulatory guidance as relevant. • As assigned by management, provide regulatory due diligence assessment of licensing/acquisition opportunities. Requirements: • BSc or MSc level degree preferably within the life sciences (PharmD, PhD preferred) • Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) • Prior experience of direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA) • A solid understanding and experience in drug development including early and late development is highly preferred. • A broad knowledge of life-cycle management is highly preferred. • Strong strategic skills including the ability to make complex decisions • Solid knowledge and understanding of global and US regulations and the US pharmaceutical market • Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance • Strong organizational, communication (both oral and written), and time management skills needed to manage multiple ongoing projects/tasks simultaneously. • Must have attention to detail and be able to solve problems with minimal supervision. • Be able to work independently with an ability to drive projects to successful outcomes. • Ability to influence others and resolve conflicts • Highly motivated and self-driven individual who enjoys being challenged. • Unquestionable ethics, professional integrity, and personal values consistent with the Genmab values About You • You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment • You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving • You are a generous collaborator who can work in teams with diverse backgrounds • You are determined to do and be your best and take pride in enabling the best work of others on the team • You are not afraid to grapple with the unknown and be innovative • You have experience working in a fast-growing, dynamic company (or a strong desire to) • You work hard and are not afraid to have a little fun while you do so Locations Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you're in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate. For US based candidates, the proposed salary band for this position is as follows: $190,720.00 $286,080.00 The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. When you join Genmab, you're joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for: 401(k) Plan: 100% match on the first 6% of contributions Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance Voluntary Plans: Critical illness, accident, and hospital indemnity insurance Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses About You You are genuinely passionate about our purpose You bring precision and excellence to all that you do You believe in our rooted-in-science approach to problem-solving You are a generous collaborator who can work in teams with a broad spectrum of backgrounds You take pride in enabling the best work of others on the team You can grapple with the unknown and be innovative You have experience working in a fast-growing, dynamic company (or a strong desire to) You work hard and are not afraid to have a little fun while you do so! Locations Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to innovate. About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences . click apply for full job details
Job Title: Clinical Research Director Location: Morristown, NJ Cambridge, MA About the Job Ready to push the limits of what's possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world. The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area is responsible for the creation of the clinical development plan in alignment with the project strategy, its endorsement by governance and its execution in close collaboration with clinical operations. The CRD is expected to advance scientific and clinical knowledge for immunology in Dermatology, incorporate new methodologies and pro-actively progress study execution. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: Create the clinical development strategy for one or more assets and document it in the clinical development plan in collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing. Advance the CDP through internal management review. Leads a clinical subteam to design clinical studies and to create an abbreviated and full clinical study protocol. Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations. Review documents supporting clinical development such as Investigator's brochure, regulatory documents for IND/CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval. Support drug registrations (contribution to submission dossiers label draft, regulatory response during the review process, Advisory Committee preparation). Contribute to data review, interpretation and publication of clinical study results. Represent Clinical Development at Health Authorities and incorporating advise into development strategy. Maintain or establish interaction with external scientific and clinical communities and to incorporate pertinent advice and learnings into the internal program. Align company position on clinical strategy with partner in alliance projects. translate biology into clinic in close collaboration with research and translational medicine. evaluate clinical aspects of business development opportunities as needed. apply high ethical standards and work with integrity. Scientific and Technical Expertise: This position requires a strong scientific and clinical foundation in dermatology. Advanced leadership skills and the ability to effectively collaborate with external partners, regulators, and diverse internal stakeholders and collaborators are essential prerequisites. Be experienced in advancing assets from discovery into clinical development. Have experience in novel approaches in translational medicine. Have and maintain deep scientific, technical and clinical knowledge in Dermatology. Demonstrated problem solving skills. Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area. Be able to translate current understanding of disease pathogenesis into functional consequences and clinical outcome. Have an understanding of novel biomarker and precision medicine approaches, novel clinical trial designs, endpoints and statistical methods. Understand the competitive environment. Have established connections within the medical field of their expertise. Have a credible publication record. About You Basic Qualifications: Medical Doctor. Should be board certified or equivalent in dermatology or allergy/immunology. Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME) or equivalent. More than 5 years of clinical or scientific and/or more than >10 years industry experience within the field of dermatology. Strong scientific and academic background within clinical research, pharmaceutical experience or experimental medicine experience in the respective therapeutic area preferred. Knowledge of drug development preferred. Strong interpersonal, communication, presentation, negotiation and networking skills in a cross-cultural global environment. Performance oriented with ability to work along agreed timelines and a focus on strategy and execution. Outstanding communicator. Excellent problem-solving, conflict-resolution and decision-making skills. Fluent in English (verbal and written communication). Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
10/01/2025
Full time
Job Title: Clinical Research Director Location: Morristown, NJ Cambridge, MA About the Job Ready to push the limits of what's possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world. The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area is responsible for the creation of the clinical development plan in alignment with the project strategy, its endorsement by governance and its execution in close collaboration with clinical operations. The CRD is expected to advance scientific and clinical knowledge for immunology in Dermatology, incorporate new methodologies and pro-actively progress study execution. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: Create the clinical development strategy for one or more assets and document it in the clinical development plan in collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing. Advance the CDP through internal management review. Leads a clinical subteam to design clinical studies and to create an abbreviated and full clinical study protocol. Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations. Review documents supporting clinical development such as Investigator's brochure, regulatory documents for IND/CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval. Support drug registrations (contribution to submission dossiers label draft, regulatory response during the review process, Advisory Committee preparation). Contribute to data review, interpretation and publication of clinical study results. Represent Clinical Development at Health Authorities and incorporating advise into development strategy. Maintain or establish interaction with external scientific and clinical communities and to incorporate pertinent advice and learnings into the internal program. Align company position on clinical strategy with partner in alliance projects. translate biology into clinic in close collaboration with research and translational medicine. evaluate clinical aspects of business development opportunities as needed. apply high ethical standards and work with integrity. Scientific and Technical Expertise: This position requires a strong scientific and clinical foundation in dermatology. Advanced leadership skills and the ability to effectively collaborate with external partners, regulators, and diverse internal stakeholders and collaborators are essential prerequisites. Be experienced in advancing assets from discovery into clinical development. Have experience in novel approaches in translational medicine. Have and maintain deep scientific, technical and clinical knowledge in Dermatology. Demonstrated problem solving skills. Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area. Be able to translate current understanding of disease pathogenesis into functional consequences and clinical outcome. Have an understanding of novel biomarker and precision medicine approaches, novel clinical trial designs, endpoints and statistical methods. Understand the competitive environment. Have established connections within the medical field of their expertise. Have a credible publication record. About You Basic Qualifications: Medical Doctor. Should be board certified or equivalent in dermatology or allergy/immunology. Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME) or equivalent. More than 5 years of clinical or scientific and/or more than >10 years industry experience within the field of dermatology. Strong scientific and academic background within clinical research, pharmaceutical experience or experimental medicine experience in the respective therapeutic area preferred. Knowledge of drug development preferred. Strong interpersonal, communication, presentation, negotiation and networking skills in a cross-cultural global environment. Performance oriented with ability to work along agreed timelines and a focus on strategy and execution. Outstanding communicator. Excellent problem-solving, conflict-resolution and decision-making skills. Fluent in English (verbal and written communication). Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Job Title: Clinical Research Director Location: Morristown, NJ Cambridge, MA About the Job Ready to push the limits of what's possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world. The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area is responsible for the creation of the clinical development plan in alignment with the project strategy, its endorsement by governance and its execution in close collaboration with clinical operations. The CRD is expected to advance scientific and clinical knowledge for immunology in Dermatology, incorporate new methodologies and pro-actively progress study execution. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: Create the clinical development strategy for one or more assets and document it in the clinical development plan in collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing. Advance the CDP through internal management review. Leads a clinical subteam to design clinical studies and to create an abbreviated and full clinical study protocol. Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations. Review documents supporting clinical development such as Investigator's brochure, regulatory documents for IND/CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval. Support drug registrations (contribution to submission dossiers label draft, regulatory response during the review process, Advisory Committee preparation). Contribute to data review, interpretation and publication of clinical study results. Represent Clinical Development at Health Authorities and incorporating advise into development strategy. Maintain or establish interaction with external scientific and clinical communities and to incorporate pertinent advice and learnings into the internal program. Align company position on clinical strategy with partner in alliance projects. translate biology into clinic in close collaboration with research and translational medicine. evaluate clinical aspects of business development opportunities as needed. apply high ethical standards and work with integrity. Scientific and Technical Expertise: This position requires a strong scientific and clinical foundation in dermatology. Advanced leadership skills and the ability to effectively collaborate with external partners, regulators, and diverse internal stakeholders and collaborators are essential prerequisites. Be experienced in advancing assets from discovery into clinical development. Have experience in novel approaches in translational medicine. Have and maintain deep scientific, technical and clinical knowledge in Dermatology. Demonstrated problem solving skills. Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area. Be able to translate current understanding of disease pathogenesis into functional consequences and clinical outcome. Have an understanding of novel biomarker and precision medicine approaches, novel clinical trial designs, endpoints and statistical methods. Understand the competitive environment. Have established connections within the medical field of their expertise. Have a credible publication record. About You Basic Qualifications: Medical Doctor. Should be board certified or equivalent in dermatology or allergy/immunology. Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME) or equivalent. More than 5 years of clinical or scientific and/or more than >10 years industry experience within the field of dermatology. Strong scientific and academic background within clinical research, pharmaceutical experience or experimental medicine experience in the respective therapeutic area preferred. Knowledge of drug development preferred. Strong interpersonal, communication, presentation, negotiation and networking skills in a cross-cultural global environment. Performance oriented with ability to work along agreed timelines and a focus on strategy and execution. Outstanding communicator. Excellent problem-solving, conflict-resolution and decision-making skills. Fluent in English (verbal and written communication). Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
10/01/2025
Full time
Job Title: Clinical Research Director Location: Morristown, NJ Cambridge, MA About the Job Ready to push the limits of what's possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world. The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area is responsible for the creation of the clinical development plan in alignment with the project strategy, its endorsement by governance and its execution in close collaboration with clinical operations. The CRD is expected to advance scientific and clinical knowledge for immunology in Dermatology, incorporate new methodologies and pro-actively progress study execution. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: Create the clinical development strategy for one or more assets and document it in the clinical development plan in collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing. Advance the CDP through internal management review. Leads a clinical subteam to design clinical studies and to create an abbreviated and full clinical study protocol. Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations. Review documents supporting clinical development such as Investigator's brochure, regulatory documents for IND/CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval. Support drug registrations (contribution to submission dossiers label draft, regulatory response during the review process, Advisory Committee preparation). Contribute to data review, interpretation and publication of clinical study results. Represent Clinical Development at Health Authorities and incorporating advise into development strategy. Maintain or establish interaction with external scientific and clinical communities and to incorporate pertinent advice and learnings into the internal program. Align company position on clinical strategy with partner in alliance projects. translate biology into clinic in close collaboration with research and translational medicine. evaluate clinical aspects of business development opportunities as needed. apply high ethical standards and work with integrity. Scientific and Technical Expertise: This position requires a strong scientific and clinical foundation in dermatology. Advanced leadership skills and the ability to effectively collaborate with external partners, regulators, and diverse internal stakeholders and collaborators are essential prerequisites. Be experienced in advancing assets from discovery into clinical development. Have experience in novel approaches in translational medicine. Have and maintain deep scientific, technical and clinical knowledge in Dermatology. Demonstrated problem solving skills. Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area. Be able to translate current understanding of disease pathogenesis into functional consequences and clinical outcome. Have an understanding of novel biomarker and precision medicine approaches, novel clinical trial designs, endpoints and statistical methods. Understand the competitive environment. Have established connections within the medical field of their expertise. Have a credible publication record. About You Basic Qualifications: Medical Doctor. Should be board certified or equivalent in dermatology or allergy/immunology. Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME) or equivalent. More than 5 years of clinical or scientific and/or more than >10 years industry experience within the field of dermatology. Strong scientific and academic background within clinical research, pharmaceutical experience or experimental medicine experience in the respective therapeutic area preferred. Knowledge of drug development preferred. Strong interpersonal, communication, presentation, negotiation and networking skills in a cross-cultural global environment. Performance oriented with ability to work along agreed timelines and a focus on strategy and execution. Outstanding communicator. Excellent problem-solving, conflict-resolution and decision-making skills. Fluent in English (verbal and written communication). Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Job Title: Clinical Research Director Location: Morristown, NJ Cambridge, MA About the Job Ready to push the limits of what's possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world. The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area is responsible for the creation of the clinical development plan in alignment with the project strategy, its endorsement by governance and its execution in close collaboration with clinical operations. The CRD is expected to advance scientific and clinical knowledge for immunology in Dermatology, incorporate new methodologies and pro-actively progress study execution. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: Create the clinical development strategy for one or more assets and document it in the clinical development plan in collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing. Advance the CDP through internal management review. Leads a clinical subteam to design clinical studies and to create an abbreviated and full clinical study protocol. Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations. Review documents supporting clinical development such as Investigator's brochure, regulatory documents for IND/CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval. Support drug registrations (contribution to submission dossiers label draft, regulatory response during the review process, Advisory Committee preparation). Contribute to data review, interpretation and publication of clinical study results. Represent Clinical Development at Health Authorities and incorporating advise into development strategy. Maintain or establish interaction with external scientific and clinical communities and to incorporate pertinent advice and learnings into the internal program. Align company position on clinical strategy with partner in alliance projects. translate biology into clinic in close collaboration with research and translational medicine. evaluate clinical aspects of business development opportunities as needed. apply high ethical standards and work with integrity. Scientific and Technical Expertise: This position requires a strong scientific and clinical foundation in dermatology. Advanced leadership skills and the ability to effectively collaborate with external partners, regulators, and diverse internal stakeholders and collaborators are essential prerequisites. Be experienced in advancing assets from discovery into clinical development. Have experience in novel approaches in translational medicine. Have and maintain deep scientific, technical and clinical knowledge in Dermatology. Demonstrated problem solving skills. Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area. Be able to translate current understanding of disease pathogenesis into functional consequences and clinical outcome. Have an understanding of novel biomarker and precision medicine approaches, novel clinical trial designs, endpoints and statistical methods. Understand the competitive environment. Have established connections within the medical field of their expertise. Have a credible publication record. About You Basic Qualifications: Medical Doctor. Should be board certified or equivalent in dermatology or allergy/immunology. Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME) or equivalent. More than 5 years of clinical or scientific and/or more than >10 years industry experience within the field of dermatology. Strong scientific and academic background within clinical research, pharmaceutical experience or experimental medicine experience in the respective therapeutic area preferred. Knowledge of drug development preferred. Strong interpersonal, communication, presentation, negotiation and networking skills in a cross-cultural global environment. Performance oriented with ability to work along agreed timelines and a focus on strategy and execution. Outstanding communicator. Excellent problem-solving, conflict-resolution and decision-making skills. Fluent in English (verbal and written communication). Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
10/01/2025
Full time
Job Title: Clinical Research Director Location: Morristown, NJ Cambridge, MA About the Job Ready to push the limits of what's possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world. The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area is responsible for the creation of the clinical development plan in alignment with the project strategy, its endorsement by governance and its execution in close collaboration with clinical operations. The CRD is expected to advance scientific and clinical knowledge for immunology in Dermatology, incorporate new methodologies and pro-actively progress study execution. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: Create the clinical development strategy for one or more assets and document it in the clinical development plan in collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing. Advance the CDP through internal management review. Leads a clinical subteam to design clinical studies and to create an abbreviated and full clinical study protocol. Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations. Review documents supporting clinical development such as Investigator's brochure, regulatory documents for IND/CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval. Support drug registrations (contribution to submission dossiers label draft, regulatory response during the review process, Advisory Committee preparation). Contribute to data review, interpretation and publication of clinical study results. Represent Clinical Development at Health Authorities and incorporating advise into development strategy. Maintain or establish interaction with external scientific and clinical communities and to incorporate pertinent advice and learnings into the internal program. Align company position on clinical strategy with partner in alliance projects. translate biology into clinic in close collaboration with research and translational medicine. evaluate clinical aspects of business development opportunities as needed. apply high ethical standards and work with integrity. Scientific and Technical Expertise: This position requires a strong scientific and clinical foundation in dermatology. Advanced leadership skills and the ability to effectively collaborate with external partners, regulators, and diverse internal stakeholders and collaborators are essential prerequisites. Be experienced in advancing assets from discovery into clinical development. Have experience in novel approaches in translational medicine. Have and maintain deep scientific, technical and clinical knowledge in Dermatology. Demonstrated problem solving skills. Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area. Be able to translate current understanding of disease pathogenesis into functional consequences and clinical outcome. Have an understanding of novel biomarker and precision medicine approaches, novel clinical trial designs, endpoints and statistical methods. Understand the competitive environment. Have established connections within the medical field of their expertise. Have a credible publication record. About You Basic Qualifications: Medical Doctor. Should be board certified or equivalent in dermatology or allergy/immunology. Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME) or equivalent. More than 5 years of clinical or scientific and/or more than >10 years industry experience within the field of dermatology. Strong scientific and academic background within clinical research, pharmaceutical experience or experimental medicine experience in the respective therapeutic area preferred. Knowledge of drug development preferred. Strong interpersonal, communication, presentation, negotiation and networking skills in a cross-cultural global environment. Performance oriented with ability to work along agreed timelines and a focus on strategy and execution. Outstanding communicator. Excellent problem-solving, conflict-resolution and decision-making skills. Fluent in English (verbal and written communication). Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Job Title: Clinical Research Director Location: Morristown, NJ Cambridge, MA About the Job Ready to push the limits of what's possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world. The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area is responsible for the creation of the clinical development plan in alignment with the project strategy, its endorsement by governance and its execution in close collaboration with clinical operations. The CRD is expected to advance scientific and clinical knowledge for immunology in Dermatology, incorporate new methodologies and pro-actively progress study execution. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: Create the clinical development strategy for one or more assets and document it in the clinical development plan in collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing. Advance the CDP through internal management review. Leads a clinical subteam to design clinical studies and to create an abbreviated and full clinical study protocol. Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations. Review documents supporting clinical development such as Investigator's brochure, regulatory documents for IND/CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval. Support drug registrations (contribution to submission dossiers label draft, regulatory response during the review process, Advisory Committee preparation). Contribute to data review, interpretation and publication of clinical study results. Represent Clinical Development at Health Authorities and incorporating advise into development strategy. Maintain or establish interaction with external scientific and clinical communities and to incorporate pertinent advice and learnings into the internal program. Align company position on clinical strategy with partner in alliance projects. translate biology into clinic in close collaboration with research and translational medicine. evaluate clinical aspects of business development opportunities as needed. apply high ethical standards and work with integrity. Scientific and Technical Expertise: This position requires a strong scientific and clinical foundation in dermatology. Advanced leadership skills and the ability to effectively collaborate with external partners, regulators, and diverse internal stakeholders and collaborators are essential prerequisites. Be experienced in advancing assets from discovery into clinical development. Have experience in novel approaches in translational medicine. Have and maintain deep scientific, technical and clinical knowledge in Dermatology. Demonstrated problem solving skills. Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area. Be able to translate current understanding of disease pathogenesis into functional consequences and clinical outcome. Have an understanding of novel biomarker and precision medicine approaches, novel clinical trial designs, endpoints and statistical methods. Understand the competitive environment. Have established connections within the medical field of their expertise. Have a credible publication record. About You Basic Qualifications: Medical Doctor. Should be board certified or equivalent in dermatology or allergy/immunology. Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME) or equivalent. More than 5 years of clinical or scientific and/or more than >10 years industry experience within the field of dermatology. Strong scientific and academic background within clinical research, pharmaceutical experience or experimental medicine experience in the respective therapeutic area preferred. Knowledge of drug development preferred. Strong interpersonal, communication, presentation, negotiation and networking skills in a cross-cultural global environment. Performance oriented with ability to work along agreed timelines and a focus on strategy and execution. Outstanding communicator. Excellent problem-solving, conflict-resolution and decision-making skills. Fluent in English (verbal and written communication). Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
10/01/2025
Full time
Job Title: Clinical Research Director Location: Morristown, NJ Cambridge, MA About the Job Ready to push the limits of what's possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world. The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area is responsible for the creation of the clinical development plan in alignment with the project strategy, its endorsement by governance and its execution in close collaboration with clinical operations. The CRD is expected to advance scientific and clinical knowledge for immunology in Dermatology, incorporate new methodologies and pro-actively progress study execution. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: Create the clinical development strategy for one or more assets and document it in the clinical development plan in collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing. Advance the CDP through internal management review. Leads a clinical subteam to design clinical studies and to create an abbreviated and full clinical study protocol. Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations. Review documents supporting clinical development such as Investigator's brochure, regulatory documents for IND/CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval. Support drug registrations (contribution to submission dossiers label draft, regulatory response during the review process, Advisory Committee preparation). Contribute to data review, interpretation and publication of clinical study results. Represent Clinical Development at Health Authorities and incorporating advise into development strategy. Maintain or establish interaction with external scientific and clinical communities and to incorporate pertinent advice and learnings into the internal program. Align company position on clinical strategy with partner in alliance projects. translate biology into clinic in close collaboration with research and translational medicine. evaluate clinical aspects of business development opportunities as needed. apply high ethical standards and work with integrity. Scientific and Technical Expertise: This position requires a strong scientific and clinical foundation in dermatology. Advanced leadership skills and the ability to effectively collaborate with external partners, regulators, and diverse internal stakeholders and collaborators are essential prerequisites. Be experienced in advancing assets from discovery into clinical development. Have experience in novel approaches in translational medicine. Have and maintain deep scientific, technical and clinical knowledge in Dermatology. Demonstrated problem solving skills. Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area. Be able to translate current understanding of disease pathogenesis into functional consequences and clinical outcome. Have an understanding of novel biomarker and precision medicine approaches, novel clinical trial designs, endpoints and statistical methods. Understand the competitive environment. Have established connections within the medical field of their expertise. Have a credible publication record. About You Basic Qualifications: Medical Doctor. Should be board certified or equivalent in dermatology or allergy/immunology. Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME) or equivalent. More than 5 years of clinical or scientific and/or more than >10 years industry experience within the field of dermatology. Strong scientific and academic background within clinical research, pharmaceutical experience or experimental medicine experience in the respective therapeutic area preferred. Knowledge of drug development preferred. Strong interpersonal, communication, presentation, negotiation and networking skills in a cross-cultural global environment. Performance oriented with ability to work along agreed timelines and a focus on strategy and execution. Outstanding communicator. Excellent problem-solving, conflict-resolution and decision-making skills. Fluent in English (verbal and written communication). Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Cygnal, a new biology platform company, was founded by Flagship Pioneering to pioneer the field of exoneural biology - the impact of the peripheral nervous system on cancer, the immune system, metabolism, and regeneration. The company is applying cutting-edge neuroscience to elucidate novel therapies to treat cancer progression and metastasis, autoimmune conditions, inflammation, and other diseases. Flagship Pioneering conceives, creates, resources, and develops first-in-category life sciences companies to transform human health and sustainability. Since its launch in 2000, the firm has applied a unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in over $30 billion in aggregate value. To date, Flagship is backed by >$3 billion of aggregate capital commitments, of which over $1.4 billion has been deployed toward the founding and growth of its pioneering companies alongside >$10 billion of follow-on investments from other institutions. The current Flagship ecosystem includes Denali Therapeutics (NASDAQ: DNLI ), Evelo Biosciences (NASDAQ: EVLO ), Moderna Therapeutics (NASDAQ: MRNA ), Rubius Therapeutics (NASDAQ: RUBY ), Seres Therapeutics (NASDAQ: MCRB ), and Syros Pharmaceuticals (NASDAQ: SYRS ). The Position Cygnal Therapeutics is seeking a highly experienced, motivated Head of Program Management to join an innovative, scientifically driven, and fast paced team focused on developing therapies for cancer and inflammatory diseases. The successful candidate will report to the Chief Medical Officer and be a self-starter who thrives in a highly collaborative and fast paced environment. The successful candidate will be a highly credible thought partner with senior stakeholders because this will be a high visibility role, both internally and externally. Key Responsibilities Define our project management approach at Cygnal, with a focus on development programs, but also inclusion of discovery activities. Build Cygnal's Project Management infrastructure and capabilities. Operationalize and lead Cygnal Project Management activities, including timelines, Gantt charts, budgets, resourcing, prioritization, risk and issue management, governance, reporting, and decision support. Work closely and collaboratively in a multi-disciplinary team. Operate at both a strategic and high level with internal and external stakeholders, as well as roll sleeves up and be hands on with deliverables. Proactively identify sources of inefficiency and propose novel technologies and collaborations. Minimum Qualifications A. or B.S. in a relevant scientific field 15+ years Project Management, including timelines, Gantt charts, budgets, resourcing, , prioritization, risk and issue management., governance, reporting, and decision support Experience with multiple pre-clinical and clinical programs in parallel Proven ability to manage timelines and resources to drive projects toward key decision point Track record of strong leadership: Open-minded, curious, candid, trust-oriented leadership style Fast learner, flexible and adaptable, internally driven self-starter, self-aware and seeks input/ help when needed, solution focused Keen attention to detail, a strong sense of urgency and ability to work in a multi-disciplinary and team-focused environment Excellent communication and presentation skills, capable of conveying technical information and strategy in a clear and thorough manner Preferred Qualifications Advanced degree (e.g., Ph.D. in a relevant scientific field), P.M.D certification a plus. Oncology experience is desirable Wide experience spanning early and late discovery, early and late development and secondarily commercialization Business Development project management or Alliance Management experience is helpful People Management experience is a plus Recruiting and Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, "FSP") do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto. Contact Information To learn more about this exciting career opportunity please submit your resume and cover letter to .
09/14/2021
Full time
Cygnal, a new biology platform company, was founded by Flagship Pioneering to pioneer the field of exoneural biology - the impact of the peripheral nervous system on cancer, the immune system, metabolism, and regeneration. The company is applying cutting-edge neuroscience to elucidate novel therapies to treat cancer progression and metastasis, autoimmune conditions, inflammation, and other diseases. Flagship Pioneering conceives, creates, resources, and develops first-in-category life sciences companies to transform human health and sustainability. Since its launch in 2000, the firm has applied a unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in over $30 billion in aggregate value. To date, Flagship is backed by >$3 billion of aggregate capital commitments, of which over $1.4 billion has been deployed toward the founding and growth of its pioneering companies alongside >$10 billion of follow-on investments from other institutions. The current Flagship ecosystem includes Denali Therapeutics (NASDAQ: DNLI ), Evelo Biosciences (NASDAQ: EVLO ), Moderna Therapeutics (NASDAQ: MRNA ), Rubius Therapeutics (NASDAQ: RUBY ), Seres Therapeutics (NASDAQ: MCRB ), and Syros Pharmaceuticals (NASDAQ: SYRS ). The Position Cygnal Therapeutics is seeking a highly experienced, motivated Head of Program Management to join an innovative, scientifically driven, and fast paced team focused on developing therapies for cancer and inflammatory diseases. The successful candidate will report to the Chief Medical Officer and be a self-starter who thrives in a highly collaborative and fast paced environment. The successful candidate will be a highly credible thought partner with senior stakeholders because this will be a high visibility role, both internally and externally. Key Responsibilities Define our project management approach at Cygnal, with a focus on development programs, but also inclusion of discovery activities. Build Cygnal's Project Management infrastructure and capabilities. Operationalize and lead Cygnal Project Management activities, including timelines, Gantt charts, budgets, resourcing, prioritization, risk and issue management, governance, reporting, and decision support. Work closely and collaboratively in a multi-disciplinary team. Operate at both a strategic and high level with internal and external stakeholders, as well as roll sleeves up and be hands on with deliverables. Proactively identify sources of inefficiency and propose novel technologies and collaborations. Minimum Qualifications A. or B.S. in a relevant scientific field 15+ years Project Management, including timelines, Gantt charts, budgets, resourcing, , prioritization, risk and issue management., governance, reporting, and decision support Experience with multiple pre-clinical and clinical programs in parallel Proven ability to manage timelines and resources to drive projects toward key decision point Track record of strong leadership: Open-minded, curious, candid, trust-oriented leadership style Fast learner, flexible and adaptable, internally driven self-starter, self-aware and seeks input/ help when needed, solution focused Keen attention to detail, a strong sense of urgency and ability to work in a multi-disciplinary and team-focused environment Excellent communication and presentation skills, capable of conveying technical information and strategy in a clear and thorough manner Preferred Qualifications Advanced degree (e.g., Ph.D. in a relevant scientific field), P.M.D certification a plus. Oncology experience is desirable Wide experience spanning early and late discovery, early and late development and secondarily commercialization Business Development project management or Alliance Management experience is helpful People Management experience is a plus Recruiting and Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, "FSP") do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto. Contact Information To learn more about this exciting career opportunity please submit your resume and cover letter to .
Minimum Required Skills: biologics drug development, Preclinical Program Management, Phase II Program Management, Phase III Program Management, Oncology or Immunology, Implementing / Enhancing PM Processes, Budget Management, Alliance Management, Timeline Oversight, Resource Allocation Ready to drive program management for multiple pharmaceutical programs spanning early discovery and preclinical through late stage clinical trials? Check out this new, direct-hire position for a Senior Director or Director of Program Management. Top Reasons to Work with Us - Pre-IPO with recent (summer 2020) Series B funding of over $95MM - - Immuno-oncology platform with potential to impact neurodegeneration, inflammation, and more - Scientific advisory board includes world renowned scientists - Expected to enter clinic by 2021 What You Will Be Doing This is a pivotal role for our growing organization and our first internal PM hire. Reporting directly to Executive-level, you will lead program management for all 5+ of our programs that currently span from early discovery through IND-enabling studies. We expect to enter the clinic by 2021, and you will continue to drive these programs through clinical phase I and beyond. As our first internal PM hire, you will enhance and build on the PM processes and systems set in place by our current project management consultant. For the foreseeable future, you will not have any direct reports. Responsibilities include: - Drive program success through project management - Timeline creation and management - Budget development and maintenance - Risk assessment - Resource allocation - Facilitation of meetings - Development of agendas - Creation of meeting minutes - Tracking of action items - Provide updates to functional leaders and senior management - Assist in preparing presentations for executives and board leaders - Potential alliance management What You Need for this Position REQUIRED - Bachelor's degree minimum. Advanced degree in life sciences preferred. - 8+ years of total industry / non-academic experience - 3+ years' experience in project or program management within the biotech / pharma industry - Biologics drug development - Extensive understanding of all aspects of drug development, including clinical, nonclinical, regulatory, CMC, ideally from early discovery through clinical phase III or even through launch PREFERRED - IND filing experience - Experience in immuno-oncology, oncology, or immunology - Alliance management What's In It for You Our employees are the most important part of our business. We offer competitive compensation (base, bonus, stock option potential) along with generous benefits including medical, dental, life, 401K, PTO, holidays, and more!So, if you are a Director / Sr. Director of Program Management with experience, please apply today. The hiring manager is already interviewing, so don't hesitate! Applicants must be authorized to work in the U.S.Please apply directly to by clicking 'Click Here to Apply' with your Word resume! Looking forward to receiving your resume and going over the position in more detail with you. - Not a fit for this position? Click the link at the bottom of this email to search all of our open positions. Looking forward to receiving your resume! CyberCoders CyberCoders, Inc is proud to be an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law. Your Right to Work - In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire. Copyright 1999 - 2020 . CyberCoders, Inc. All rights reserved. - provided by Dice
09/29/2020
Full time
Minimum Required Skills: biologics drug development, Preclinical Program Management, Phase II Program Management, Phase III Program Management, Oncology or Immunology, Implementing / Enhancing PM Processes, Budget Management, Alliance Management, Timeline Oversight, Resource Allocation Ready to drive program management for multiple pharmaceutical programs spanning early discovery and preclinical through late stage clinical trials? Check out this new, direct-hire position for a Senior Director or Director of Program Management. Top Reasons to Work with Us - Pre-IPO with recent (summer 2020) Series B funding of over $95MM - - Immuno-oncology platform with potential to impact neurodegeneration, inflammation, and more - Scientific advisory board includes world renowned scientists - Expected to enter clinic by 2021 What You Will Be Doing This is a pivotal role for our growing organization and our first internal PM hire. Reporting directly to Executive-level, you will lead program management for all 5+ of our programs that currently span from early discovery through IND-enabling studies. We expect to enter the clinic by 2021, and you will continue to drive these programs through clinical phase I and beyond. As our first internal PM hire, you will enhance and build on the PM processes and systems set in place by our current project management consultant. For the foreseeable future, you will not have any direct reports. Responsibilities include: - Drive program success through project management - Timeline creation and management - Budget development and maintenance - Risk assessment - Resource allocation - Facilitation of meetings - Development of agendas - Creation of meeting minutes - Tracking of action items - Provide updates to functional leaders and senior management - Assist in preparing presentations for executives and board leaders - Potential alliance management What You Need for this Position REQUIRED - Bachelor's degree minimum. Advanced degree in life sciences preferred. - 8+ years of total industry / non-academic experience - 3+ years' experience in project or program management within the biotech / pharma industry - Biologics drug development - Extensive understanding of all aspects of drug development, including clinical, nonclinical, regulatory, CMC, ideally from early discovery through clinical phase III or even through launch PREFERRED - IND filing experience - Experience in immuno-oncology, oncology, or immunology - Alliance management What's In It for You Our employees are the most important part of our business. We offer competitive compensation (base, bonus, stock option potential) along with generous benefits including medical, dental, life, 401K, PTO, holidays, and more!So, if you are a Director / Sr. Director of Program Management with experience, please apply today. The hiring manager is already interviewing, so don't hesitate! Applicants must be authorized to work in the U.S.Please apply directly to by clicking 'Click Here to Apply' with your Word resume! Looking forward to receiving your resume and going over the position in more detail with you. - Not a fit for this position? Click the link at the bottom of this email to search all of our open positions. Looking forward to receiving your resume! CyberCoders CyberCoders, Inc is proud to be an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law. Your Right to Work - In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire. Copyright 1999 - 2020 . CyberCoders, Inc. All rights reserved. - provided by Dice