54 jobs found

The Associate Dean for Portfolio Planning & Evaluation provides strategic, data-informed leadership for the planning, evaluation, and continuous improvement of academic programs within an assigned portfolio. Reporting to the Senior Associate Dean, this role serves as the portfolio's chief architect of programmatic relevance, quality assurance, and long-term sustainability, guiding the lifecycle of academic programs. The Associate Dean ensures academic offerings are aligned with institutional strategy, workforce demand, and learner success metrics through the oversight of strategic planning, program review, resource allocation, and performance evaluation. The role also provides direction and supervision to Assistant Deans, Portfolio Directors, Portfolio Managers, and Teaching & Learning Faculty to ensure forward-looking, high-functioning operations and consistent academic standards. Success in this position is measured by the ability to drive programmatic excellence, lead effective planning cycles, cultivate high-performing teams and ensure the ongoing relevance and quality of learning experiences across the portfolio, while remaining responsive to an evolving educational and workforce landscape. Key Duties and Responsibilities: Lead the strategic planning and evaluation of assigned academic programs, in the Marketing, Management, and Health Care Administration department, ensuring alignment with institutional priorities and evolving market needs. Use data, labor market intelligence, and institutional strategy to identify growth opportunities and enhancements for long-term impact. Direct the academic program review process, use data and stakeholder input to conduct evidence-based assessment of program viability, identify improvement opportunities, and ensure compliance with accreditation and learner success standards. Make informed recommendations on program lifecycle decisions (e.g., launch, revision, suspension, or sunset) to the Senior Associate Dean based on strategic fit and performance metrics. Oversee the implementation of quality assurance processes, including curriculum reviews, faculty evaluations, and learner experience assessments. Collaborate with the Senior Associate Dean to elevate quality standards and inform operational priorities. Allocate full-time faculty and staff resources strategically across the portfolio to meet academic needs, balance workloads, and support institutional growth. Supervise and mentor Assistant Deans, Portfolio Directors, Teaching & Learning Faculty, and Portfolio Managers to ensure coordinated execution and continuous leadership development in the design and delivery of programs. Interpret and act upon student success data (e.g., persistence, retention, graduation rates) to implement academic interventions and drive improvements in learner outcomes. Collaborate with curriculum and academic operations units to guide program design, course development, and delivery innovations that enhance teaching and learning. Advocate for innovations that improve engagement and learner outcomes. Support accreditation, compliance, and institutional effectiveness initiatives by ensuring data integrity and adherence to internal and external standards. Perform other duties as assigned by the Senior Associate Dean, including supporting the Senior Associate Dean on cross-portfolio initiatives and special academic projects that strengthen program performance or stakeholder engagement. Competencies: Strategic academic planning and evaluation Program lifecycle management. Leadership and staff supervision Academic quality assurance and improvement Data-driven decision making Faculty development and mentorship Stakeholder engagement and collaboration Skills: Academic program review and analysis Data interpretation and visualization Supervisory and team development skills Strategic resource planning and allocation Curriculum and instructional planning Communication and report writing Change management and systems thinking. Key Collaborators: Senior Associate Dean: To align strategic planning and resource allocation decisions with broader academic operations and institutional priorities. Assistant Deans and Portfolio Directors: To guide implementation of planning and evaluation efforts and ensure coordinated execution across academic units. Portfolio Managers and Teaching & Learning Faculty: To provide oversight, coaching, and clarity around academic expectations, evaluation standards, and learner experience goals. Curriculum Governance Committees: To review and approve program revisions, new program proposals, and sunset recommendations. Center for Institutional Effectiveness and Analytics: To interpret student success metrics and translate insights into actionable academic improvements. Faculty Affairs & Scheduling Team (FAST) and Human Resources: To support full-time faculty staffing plans, development needs, and performance improvement strategies. External Stakeholders (e.g., accreditation bodies, industry advisory boards): To ensure programs meet workforce needs and maintain compliance with professional and regulatory expectations. Minimum Education & Experience Requirements: Education: Doctorate in Business, Business Administration, or Management from a Business School or College at an accredited institution; in a portfolio-related discipline is highly preferred. Experience: Demonstrated ability to get things done. Minimum of 5 years of academic leadership experience in higher education, including program management and faculty leadership. Preferred Education & Experience Requirements: Education: Same as required Experience: Demonstrated experience collaborating with external partners such as industry, professional associations, or community organizations. Work environment and physical demands: Work is typically performed in an office or a hybrid academic setting. Must be able to analyze large sets of data, manage competing academic priorities, and collaborate across a distributed leadership structure. Residence in or relocation to the Maryland/Washington, D.C./Northern Virginia metro area is required. All submissions should include a cover letter and resume. The University of Maryland Global Campus (UMGC) is an equal opportunity employer and complies with all applicable federal and state laws regarding nondiscrimination. UMGC is committed to a policy of equal opportunity for all persons and does not discriminate on the basis of race, color, national origin, age, marital status, sex, sexual orientation, gender identity, gender expression, disability, religion, ancestry, political affiliation or veteran status in employment, educational programs and activities, and admissions. Workplace Accommodations: The University of Maryland Global Campus Global Campus (UMGC) is committed to creating and maintaining a welcoming and inclusive working environment for people of all abilities. UMGC is dedicated to the principle that no qualified individual with a disability shall, based on disability, be excluded from participation in or be denied the benefits of the services, programs, or activities of the University, or be subjected to discrimination. For information about UMGC's Reasonable Workplace Accommodation Policy or to request an accommodation, applicants/candidates can contact Employee Accommodations via email at . Benefits Package Highlights: Generous Time Off: Enjoy 22 days of paid vacation, 15 days of sick leave, 3 personal days, and 15 paid holidays (16 during general election years). For part-time employees, time off rates will be prorated based on the number of hours worked. Comprehensive Health Coverage: Access to health care, medical with vision, dental, and prescription plans for both individuals and families, effective from the 1st of the month following your hire date. Insurance Options: Term Life Insurance, Accidental Death and Dismemberment Insurance, and Long-Term Disability (LTD) Insurance. Part-time employees working less than 0.5 FTE are not eligible for LTD. Flexible Spending Accounts: Available for medical and dependent care expenses. Retirement Plans: Choose between the Optional Retirement Program (ORP) or the Maryland State Retirement and Pension System (MSRPS). Supplemental Retirement Plans: include 401(k), 403(b), 457(b), and various Roth options. The university does not provide matching funds. Tuition Remission: Immediate availability for Regular Exempt Staff. Spouses and dependent children are eligible for undergraduate tuition remission after two years of service. NOTE: For part-time employees (at least 50 percent of the time), tuition remission benefits are prorated.

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: The primary responsibilities of this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support of multiple projects within Daiichi Sankyo's Oncology Late-Stage Development Portfolio. The individual will play a key role in making Precision Medicine a reality for patients who are likely to benefit from our therapeutics. Responsibilities: Acts as CDx representative to the Global Project Team (GPT) for any projects that definitively require a CDx for drug registration or for any project with CDPs containing multiple registrational clinical trials and are extensively exploring the predictive nature of potential CDx assays.Leads CDx project teams for the diagnostic, in full alignment with Global Project Teams (GPT) covering all areas from CDx assay development through CDx approval and launch. Creates the CDx development strategy, including partner evaluation and selection for a registrational phase project.Manages CDx development activities and deliverables in collaboration with diagnostic partner across all clinical trials within the project, including the timely deployment of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to develop CDx submission strategies.May represent DS in various Health Authority interactions for the drug trials or for approval of CDx.Keeps abreast of regulatory and policy updates in the external environment and understands the competitive landscape.Proactively shifts CDx strategy to account for external shifts. Partners with Medical Affairs and Commercial to support scientific collaborations with KEEs, and in support of pre-launch, launch and LCM activities as necessary. Direct line management responsibility including developing and mentoring of Managers, Associate Directors and Directors. May serve on CDx department extended leadership team. Qualifications: (What are the minimum requirements for the position?) Education: PhD, MD or PharmD - minimum of 12 years' experience or MS - minimum of 15 years of experience or BS/BA - minimum of 19 years of experience required Experience: Demonstrated track record of success working on multidisciplinary, international pharmaceutical development teams Experience with CDx regulatory submissions to the FDA and other health authorities globally. At least 4 years of companion diagnostic development experience within a pharmaceutical company. At least 2 years of experience managing direct reports. Competencies: Ability to lead in a highly collaborative global environment with stakeholders from multiple functional areas Strong strategic leadership skills with an ability to define, prioritize and balance team responsibilities in accordance with business and team needs Strong interpersonal and verbal and written communication skills with the ability to effectively communicate within project teams, both internal teams and alliance partner teams, and with all levels of management, including senior management, across various functions and locations Broad knowledge and understanding of established and new assay technologies.Ability to strategically think about how to incorporate new technologies into the drug development process. Knowledge of drug development process and an understanding of how diagnostic development can shape drug development and commercialization. Ability to navigate evolving CDx-relevant regulatory guidelines and provide guidance and mentorship to junior CDx members. Ability to influence without authority within the organization. Ability to inspire and to lead direct reports. Travel: Domestic and international may be required: 15% Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $230,175.00 - $383,625.00Download Our Benefits Summary PDF

Category:: Full-time Staff Subscribe:: Department:: Academic Affairs - Health Locations:: Lowell, MA Posted:: Oct 23, 2024 Closes:: Nov 6, 2025 - 11:59 PM EST Type:: Full-time Position ID:: 182380 About Middlesex Community College: Middlesex Community College (MCC), established in 1970, provides access to affordable education to prepare individuals for success and lifelong learning. We promote academic excellence, provide workforce development opportunities, and empower all learners to become productive and socially responsible members of our local and global communities. The College provides a broad range of services that are essential to attract, reward, and retain talented faculty and staff. The MCC community promotes a work environment where our employees feel supported and empowered to best serve our student population. We are proud to offer our classes on both the Bedford and Lowell campuses, as well as a robust online course offering. MCC is committed to transforming lives as we educate, challenge, and support all students as evident in our strategic plan . Job Description: Title: Director of Practical Nurse Education Unit: Non-Unit Professional ( NUP ) Department: Nursing Reports to: Senior Director of Nurse Education Date: October 28, 2024 (Reopened September 25, 2025) General Summary: The Director of Practical Nurse Education is a 12-month position, responsible for serving as administrator of record for the Practical Nursing program. The Director of Practical Nurse Education collaborates with the Senior Director of Nurse Education in establishing, maintaining, and monitoring current and sound educational practices. The Director or Practical Nurse Education provides strategic leadership for the Practical Nursing Program and serves as the administrative representative to state and federal regulatory authorities, accrediting bodies, and to pertinent professional nursing associations. The Director is responsible to students, faculty, and college administration for the safe and lawful operations of the Practical Nursing program. This includes management of the Practical Nursing Program budget, related grant budgets, maintenance and development of the Program Advisory Board meetings, and maintenance of program accreditations. This essential role encompasses collaborating with all nursing program faculty, support staff, the Senior Director of Nursing Education, and the Dean of Health to ensure continuous Practical Nursing Program improvement and alignment with the ADN program. The position requires an equity-minded, creative, and knowledgeable individual with a positive approach to program management, and a with a mindset that supports the college's strategic initiatives. The Director of Practical Nurse Education is expected to exhibit initiative, enthusiasm, and teamwork in accomplishing the responsibilities of the position. The individual who serves in this position must be committed to equity, diversity, excellence, student engagement, and success. Duties and Responsibilities: Provide academic leadership and administrative direction to the Practical Nursing Program by: Serving as the Nurse Administrator/Administrator of Record in accordance with the Massachusetts Board of Registration in Nursing and accreditation requirements for Practical Nursing Program. Overseeing planning, implementation, and evaluation of all aspects of the educational programs, including curriculum development and the nursing program systematic evaluation plan. Coordinating searches for full-time faculty and staff positions for the Practical Nursing Programs. Orienting, mentor and evaluate full-time and part-time faculty in their areas of responsibility according to the MCCC contract for Practical Nursing Program. Recruiting, interview and hire full-time and part-time faculty for Practical Nursing Programs. Preparing schedules and payroll for adjunct faculty for submission to the Dean of Health for the Practical Nursing Program. Planning and managing the budget to ensure the acquisition of necessary equipment and supplies for classrooms, laboratories and other instructional settings. Determine priorities for budgetary expenditures based on department needs; monitor budget. Developing schedules for all classes offered in the Practical Nursing Program. Preparing reports as needed for regulatory agencies, the College, and to support Nursing program initiatives and to assess the effectiveness of initiatives. Ensuring compliance with all required state regulations and accreditation criteria. Promoting and maintain responsive community relations, including a Nursing Department Advisory Board that meets at least 2 times per year. Resolving student issues as they relate to the Practical Nursing Program. Developing and renew articulation agreements with area high schools, ADN programs, and four-year institutions as appropriate. Encouraging and structure innovative professional development activities. Providing leadership and direction to faculty in development of initiatives and activities that promote positive program outcomes. Providing guidance and leadership to faculty on the use of alternative pedagogy to enhance student learning. This includes the promotion of instructional applications of technology, web-based enhancements, and e-learning. Developing and implement grants and support faculty in developing and implementing grants. Working in collaboration with relevant areas of the college to ensure that all students in the Nursing program receive appropriate academic advising. Working in collaboration with coordinators of the Nursing Program options. Participating in relevant committees of the College. Collaborate with the Senior Director of Nurse Education and Dean of Health to: Develop, implement, and assess Practical Nursing Department goals. Ensure that goals align with the institution's mission and values and support the college's strategic directions including student success initiatives. Provide leadership in grant activities for the Nursing Department. Assist with data collection, analysis and reporting. Assess programmatic needs through the program review process and oversee the assessment of institutional, departmental and course student learning outcomes. Develop and improve departmental curriculum which includes the development, revision, implementation and/or removal of courses. Maintain current knowledge of trends and practices in the field through peer association, attendance at seminars, study, and review of literature. Other duties as needed or assigned. Requirements: Maintains compliance with of Massachusetts Board of Regulations in Nursing 244 CMR 6.04(2)(a); Holds a Massachusetts Registered Nurse license in good standing Possesses an earned graduate degree in nursing Possesses a minimum of five years full-time nursing experience with at least three years full-time experience, or its equivalent, in nursing education in either: a nursing education program designed to prepare a graduate to practice as a Licensed Practical Nurse or a Registered Nurse; or a post-licensure graduate nursing education program Develops and maintains competence appropriate to administrative responsibilities including, but not limited to: orientation and mentoring to the administrator role; knowledge of M.G.L. c. 112, 74 through 81C and 244 CMR Participates in professional development in nursing education such as certification, continuing education Develops knowledge of nursing and college administration Experience working as a Practical Nurse and/or clear understanding of Practical Nursing scope of practice Maintains a commitment to the mission and philosophy of the college with an understanding and respect for the goals of college activities. Leadership, planning, management, and supervisory skills. Strong organizational skills. Ability to recognize college-wide priorities and work cooperatively and collaboratively to support their accomplishment. Financial management skills. Ability to market programs and ideas; to communicate effectively both verbally and in writing; to establish positive public relations, and to work collaboratively with people to set and achieve common goals. Knowledge of curriculum development, including theory and practice. Knowledge of nursing education and program assessment. Understanding of the need to incorporate technology into the many aspects of the college. Experience with equity-minded work and/or understanding of individuals of diverse identities such as race, ethnicity, socioeconomic level, sexual orientation, veterans, and individuals with different academic preparation levels and varying physical and learning abilities. Preferred Qualifications: Understanding of and commitment to the role of the community college in higher education. Knowledge of cultural competency skills framework. Bilingual skills a plus. Additional Information: Salary Range: $105,000 - $115,000; actual salary commensurate with academic background and experience. Employees of Middlesex Community College are considered employees of the Commonwealth of Massachusetts and receive benefits, which include: . click apply for full job details

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: This role is an integral member of the Daiichi Sankyo (DS) Global Regulatory Intelligence & Policy, Center of Excellence (GRIP CoE), and is responsible for leading US regulatory intelligence acquisition, analysis, communication, and knowledge management, as well as leading US regulatory advocacy and policy activities for assigned issue sets. The role will work closely with the Vice President, Head of North America Regulatory Affairs, other regional Regulatory Intelligence & Policy (RIP) Leads, and cross functional stakeholders, and will conduct analyses and targeted advocacy via a global lens that ensures US intelligence and policy activities are globally coordinated and globally aligned to achieve maximum impact for patients and Daiichi Sankyo business. Additionally, this role will be responsible for the management and continuous improvement of the GRIP CoE Hub designed to provide global access to critical RIP information and resources. Intelligence: The US RIP lead will: 1) Lead the acquisition, analysis, communication, and knowledge management of US regulatory intelligence (RI); 2) Interpret, analyze, and apply US regulatory intelligence to inform strategic decisions of asset teams and leadership, as well as to inform the development of DS policy positions; 3) Lead the strategic development and implementation of an assigned project portfolio (including the development of technology enabled systems, tools, processes, and key performance indicators) for identifying, analysing, and leveraging changes, trends, and other developments in the regulatory landscape, through a global lens, across all key markets where DS operates. The US RIP lead will leverage a wide variety of diverse internal and external sources, databases and networks, to interpret regulatory information into actionable insights that relate to DS's portfolio of development and marketed assets, and synthesize and communicate these findings to relevant cross-functional stakeholders, to help inform future DS regulatory/development strategies, activities and ways of working. Policy/Advocacy: The US RPI Lead will lead DS regulatory policy and advocacy activities for an assigned portfolio of policy topics. For assigned US issue sets, this role will be responsible for maintaining and efficiently and effectively communicating the current pulse of the issue, developing the DS US position, contributing to the development of Global Regulatory Affairs positions (and potentially serving as both the US and Global GRIP Lead on assigned topics), leading public commenting and other advocacy on assigned topics to ensure that DS has a voice in defining and shaping new or proposed FDA regulatory opportunities/changes/requirements (policy, regulations, guidance, pilots, workshops, etc.), and for preparing DS teams to efficiently navigate these changes to seize opportunities and to mitigate risk. Policy/advocacy activities will include but are not limited to partnering with regulators, interacting and influencing trade associations and other key external stakeholders, securing and executing opportunities to present and publish externally, briefing senior leaders, regulatory affairs teams, and other relevant functions, as well as contributing to the development and execution of assigned global regulatory policy activities. US Focus but with Global Lens/Mindset: While the core responsibilities are US focused, the US Lead will routinely engage with other regional leads and global subject matter experts in regulatory and other DS partner functions to ensure intelligence is analyzed via a global lens and that DS policy development considers the global environment and implications to maximize the impact of intelligence analysis and policy shaping activities. The US Lead may also serve as the global policy lead for specific assigned issues and will contribute to the GRIP CoE's global deliverables. The US Lead will also have a key role in cross-region mentoring and development activities. Stakeholder Engagement: The role will engage internal/external stakeholders from across functions on key regulatory topics, particularly related to biologics/oncology, including coordinating GRIP CoE activities with RA-CMC, R&D & corporate affairs as needed. Responsibilities: Regulatory Intelligence (RI) - Lead the monitoring, collection, synthesis, analysis, communication, archiving, and retrieval of key regulatory intelligence in a systematic manner for the US region, (and for a limited number of global issue sets driven by US FDA regulatory policy). - Transform regulatory information into actionable insights specific to Daiichi Sankyo, that will facilitate the rapid and efficient development and approval of Daiichi Sankyo medicines. - Contribute US regulatory intelligence content and perspective into deliverables (e.g., Quarterly GRIP Insight Reports, Ad Hoc GRIP CoE Alerts Notes; Quarterly Global SOP Committee Updates; and other fora as assigned). - Deliver insightful, proactive (e.g., from routine monitoring of priority issues) and responsive RI and analysis (e.g., in response to internal asset team and GRA Leadership queries), both through a global lens. - Leverage RI analyses to inform strategic decisions at both asset and above asset levels (e.g., using external/internal precedence, case studies, statements from regulators, etc.). - Leverage regulatory intelligence to inform the development and successful execution of Daiichi Sankyo regulatory policy goals. - Develop and maintain strong collaborative networks/relationships with cross-functional subject matter experts (SMEs) and Daiichi Sankyo partner functions that generate, analyze, and consume intelligence. - Leverage and maintain expert proficiency in the use of internal and commercial third-party RI tools, and mentor others to use. - Lead the development, implementation, maintenance, and continuous improvement of assigned elements of GRIP infrastructure (e.g., systems, tools, and processes) that enhance the efficiency and impact of the GRIP deliverables and team. - Contribute to the efficient global operation and continuous improvement of the GRIP CoE (e.g., key performance indicators, team meetings, mentoring, representing the GRIP CoE on cross-functional GRA and intel projects, vendor interactions). - Regulatory Policy Prioritization: - Identify and establish a focused set of US Regulatory Policy priorities for external engagement that are aligned with DS functions and leadership, and will have maximum positive impact on patients and accelerating the delivery of the DS portfolio. Horizon scan for emerging US regulatory policy topics; adjust priorities as needed. - Lead DS regulatory policy and advocacy activities for assigned portfolio of policy topics. For assigned issue sets: - Monitoring Communication: Efficiently and effectively monitor communicate the current pulse of priority issues to Daiichi Sankyo stakeholders via a global lens that includes global context and implications (e.g., briefings to senior leaders, including in advance of trade association interactions). Prepare Daiichi Sankyo teams to efficiently navigate policy/regulatory changes to seize opportunities and to mitigate risk. - Position Development: Develop US regulatory policy/position papers, in partnership with Daiichi Sankyo subject matter experts, ensuring alignment with key stakeholders internally to ensure a unified voice for subsequent Daiichi Sankyo advocacy. Lead or contribute to development and finalization of DS Global Positions. Potentially serve as both US Global GRIP policy lead on assigned topics. - Advocacy: Develop and execute strategic advocacy plans to achieve policy-shaping objectives for key policy topics, and grow the positive reputation of DS. Position paper messaging to drive policy shaping initiatives across multiple channels. Leverage and partner with Daiichi Sankyo cross-functional leaders and subject matter experts (e.g., from across RD, Safety, Tech/Supply and Commercial) to engage externally and increase the impact of DS advocacy. Engage with key external stakeholders including regulators and trade associations to advance and secure the adoption of the Daiichi Sankyo perspective on priority issues. Lead public commenting and other advocacy to ensure that Daiichi Sankyo has a voice in defining and shaping new or proposed FDA regulatory opportunities / changes /requirements (policy, regulations, guidance, pilots, workshops, etc.). Secure and execute opportunities for GRIP as well as other Daiichi Sankyo GRA and cross-functional leaders and subject matter experts to present and publish externally with regulators and/or other influential organizations. Reports back key insights to the GRA Leadership Team and other relevant stakeholders to inform strategic decisions. Tracks impact of advocacy efforts and applies learnings to continuously refine policy messaging and tactics to increase the impact and likelihood of success . click apply for full job details

Description: Job Title: Associate Director / Director, Study Trial Master File (TMF) Location: Bala Cynwyd, PA Travel: Approximately 10% (domestic/international) Reports to: Chief Development Officer (initially) The Company: Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (CTI-1601), is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich's ataxia. Friedreich's ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality. We have assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience. Our management team, employees, and consultants have significant expertise in discovery, non-clinical and clinical development, regulatory affairs, manufacturing and CMC. Our company's strategy is to become a leader in the treatment of rare diseases by leveraging our cell-penetrating technology platform and applying our team's know-how to the development of Nomlabofusp and our pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success. Position Summary We are seeking an experienced and detail-oriented Associate Director or Director to lead all aspects of Trial Master File (TMF) management for a single, global clinical trial. This TMF Owner will be fully accountable for the completeness, accuracy, quality, and regulatory compliance of the TMF for a global study, ensuring it remains inspection-ready throughout the study lifecycle. This is a hands-on leadership role that requires deep expertise in TMF operations, global regulatory standards, and cross-functional collaboration. The successful candidate will be a strong leader with excellent communication and collaboration skills, preferably with 10-15 years' experience in managing clinical TMFs across the US and EU, and significant vendor management experience. This role will require a minimum of 2 days a week of onsite presence (or more as business needs require) in our Bala Cynwyd, PA corporate office. Job Responsibilities TMF Oversight & Compliance Serve as the TMF lead for a global clinical trial, fully accountable for the accuracy, consistency, completeness, and regulatory compliance of the Trial Master File from study start-up through final archival Develop, update, and deliver TMF processes, procedures, and training in alignment with industry best practices and evolving regulatory requirements. Lead the TMF plan and build study eTMF and ensure completeness accordingly Ensure TMF documentation is consistent with specifications, internal SOPs, and applicable regulatory guidelines (ICH GCP, FDA, EMA, and other country-specific requirements). Maintain TMF inspection- and submission-readiness throughout the trial lifecycle, monitoring quality and implementing corrective actions when necessary. Act as the primary point of contact for all TMF-related activities, queries, and decisions for the trial. Stay current with regulatory changes and industry best practices, translating them into actionable process improvements. Process Management & Quality Control Conduct ongoing quality control reviews of TMF content to ensure accuracy, timeliness, and compliance. Establish and monitor TMF performance metrics, monitoring them, and proactively identifying and addressing documentation gaps. Report on metrics, highlighting risks, driving remediation, and presenting continuous improvement strategies to senior leadership. Drive continuous improvement in TMF operations, including CAPAs and lessons learned. Travel domestically and internationally ( 10%) for vendor oversight, study team meetings, audits, or inspections. Cross-Functional Collaboration Work closely with clinical operations, regulatory affairs, quality assurance, and other internal stakeholders to support timely and accurate documentation filing. Lead TMF-related communications with study teams, ensuring alignment on responsibilities, timelines, and expectations. Support inspection readiness activities, including internal reviews, mock inspections, and audit preparation. Manage and build strong partnerships with external vendors, CROs, and internal stakeholders to ensure consistent TMF standards, timely document flow, and adherence to project milestones. Manage third-party TMF vendor(s) involved in the trial, ensuring adherence to quality standards, timelines, and deliverables. Serve as the business owner of the eTMF system for the study, including oversight of configuration, access controls, and change management. Oversee records management for the trial, including off-site storage and archival, ensuring compliant chain-of-custody practices. Inspection Readiness & Regulatory Support Ensure the TMF is prepared for regulatory inspection at any point during the trial. Lead TMF reviews and remediation efforts in preparation for audits or inspections. Assist with audit response and CAPA development as needed. Other responsibilities Perform related duties as necessary or as assigned Requirements: Qualifications Minimum of 15+ years of relevant industry experience with a Bachelor's degree, or 10+ years with a postgraduate degree. Experience managing TMF for global clinical trials including direct vendor oversight Proven, hands-on experience with electronic TMF (eTMF) systems (e.g., Veeva Vault) and related clinical documentation platforms. Deep expertise in global regulatory requirements (e.g., ICH-GCP, FDA, EMA) and well-versed in industry best practices for Trial Master File (TMF) operations. Strong, practical knowledge of the DIA TMF Reference Model and its application within operational settings. Broad understanding of end-to-end clinical trial operations and processes, with direct involvement in inspection readiness and compliance activities. Exceptional communication skills-able to clearly convey complex information to diverse stakeholders and foster collaboration across cross-functional teams. Highly skilled in project management, with the ability to oversee multiple concurrent initiatives, establish priorities, and consistently meet critical deadlines. Recognized for strategic problem-solving, organizational acumen, and meticulous attention to detail in a fast-paced environment. Ability and willingness to work onsite at least two days per week, while maintaining strong collaboration in a hybrid work model. Benefits: Larimar Therapeutics offers all employees a competitive salary with frequent market benchmarking, incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy. We are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner. We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live. Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and business needs. The decisions and criteria governing the relationship with all candidates and employees are made in a non-discriminatory manner-without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes. PI91f15ea60e7d-1581

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Reporting to the Sr. Director, Medical Affairs QA, the Director of Medical Affairs QA is responsible for providing strategic leadership and comprehensive quality oversight across all Medical Affairs programs. This role involves deputizing for the Sr. Director, representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high impact projects, fostering s culture of excellence and compliance and working toward building a quality mindset with Medical Affairs. Support the Sr. Director's Medical Affairs Quality strategy by partnering with members and business stakeholders for both Oncology and Specialty Affairs Medical Affairs teams. Will provide strategic and proactive QA Leadership and direction for respective interventional/non-interventional programs such as post marketing studies or post approval commitments, medical access programs. Partner with Medical Affairs to facilitate the implementation of a risk-based quality management process fully embedded through trial design, execution and submission including all vendor managed activities with the goal of achieving the highest data quality standards, full adherence to patient's rights and well-being and in support of successful Health Authority inspections and approvals - Proactively partner and lead the strategic collaboration with other GxP Quality representatives, and act as the Quality Assurance point person for all GxP matters within the Medical Affairs team and with other related business stakeholders. Drive necessary change and efficiency through provision of effective feedback and recommendations. Identify and raise areas of concern where quality gaps have been identified and partner with Medical Affairs leaders to assign tasks to remove those gaps. - Provide operational QA leadership and Quality Oversight for the Quality Plan execution, Health Authority Commitments, Critical Incidents including, respective escalation and the CAPA Management Process for the respective business areas. Responsibilities: Leadership and Project Management: Lead the end-to-end quality execution across Medical Affairs programs, ensuring compliance with GCP, GPV, GPEP, Data Protection, and other local regulatory requirements throughout the planning and execution of Interventional, Non-Interventional, Managed Access Programs, and Investigator-Initiated Studies. Provide comprehensive quality oversight for Medical Affairs activities, including interventional studies, non-interventional studies, Compassionate Use or Managed Access Programs. Collaborate with the Sr Director, Medical Affairs QA to conduct quality reviews of product profiles, ensuring thorough management review of all quality and compliance topics, including Key Quality Indicators (KQIs). Identify and drive initiatives for continuous quality improvement. Deputize for the Sr. Director, Medical Affairs QA as needed. Cross-functional and Global Team Participation: Drive quality excellence through effective business partnerships with stakeholders across functions. Provide leadership and guidance on assigned programs, collaborating closely with the Head of Development and Medical Affairs QA to implement the quality strategy and/or quality plan, fostering a culture of quality within Medical Affairs. Lead strategic initiatives in collaboration with Medical Affairs stakeholders to uphold the ethical conduct of interventional, non-interventional, investigator-initiated trials, and managed access programs to the highest quality standards. Act as the primary QA point of contact for all Medical Affairs programs, collaborating with GxP Quality representatives across the organization Quality Management and Continuous Improvement: Lead effective communication efforts within the Medical Affairs team, ensuring collaboration with other GxP QA functions (e.g., GMP/IMP QA, Audit and Compliance, QMS QA, Development QA, and PVQA) to address GxP-related issues impacting clinical/medical access programs. Drive necessary change and efficiency through provision of effective feedback and recommendations. Provide leadership and direction in the development and execution of Corrective and Preventive Actions (CAPAs), ensuring timely closure, effective checks, and the proper escalation of critical issues. Partner with QMS QA to ensure consistent implementation of applicable Quality Standards in Medical Affairs and identify continuous improvement opportunities in quality and compliance. Evaluate risks impacting GxP compliance within Medical Affairs, driving ongoing improvements to meet regulatory requirements and company policies and standards. Interpret regulations, company standards, and guidelines for personnel involved in assigned programs or continuous improvement projects, championing and implementing study/program-specific quality plans for proactive quality management. Collaborate with the audit function, Data Management teams, MA stakeholders and CROs to ensure high data quality, proactively identifying and resolving issues throughout the clinical trial process. Customer Focus / Stakeholder: Engagement Lead the implementation of the quality strategy in alignment with the Medical Affairs business strategy. Monitor and track the breakdown of the Quality Manual into an annual Quality Plan, including quality risk assessments and inspection readiness components for designated programs. Ensure proactive representation of Quality professionals in strategic project teams and GCP discussions, contributing to the broader success of Medical Affairs goals. Promote open communication and effective business partnering to support the cross-functional implementation of Global RD/PV QA's Strategy, Vision, and Mission. Cultivate a culture focused on solution-oriented, evidence-based decision-making and openness to innovative working methods and technologies across cross-functional teams. Ensure consistent and proactive representation of Quality at all stages of the program management process. May Interact with management at all levels and external audiences, leveraging a strong industry network. Represents the organization in strategic discussions and quality governance meetings. Quality Oversight: Ensure the timely escalation of incidents/issues within Medical Affairs and QA, providing oversight for deviation and incident investigations, and ensuring that effective CAPAs are defined, implemented, and tracked for closure. Oversee quality management within Medical Affairs teams for third-party/vendor activities, ensuring that quality standards are maintained in outsourced operations. Ensure CAPA effectiveness checks are conducted and provide updates on quality status to business functions in a timely manner through appropriate forums, such as Quarterly Quality Reports (QQRs) and Quality Review Boards (QRBs).Collaborate with business process owners to monitor the effectiveness of clinical development processes through KQIs, demonstrating process control and ensuring compliance levels are met. Lead the process for reviewing and assessing KQIs regularly, preparing management documentation for the QA Head, and ensuring that any gaps or risks are addressed with continuous improvement initiatives. Work directly with business process owners to integrate quality into all stages of process development, ensuring stakeholders are educated on common deviations. Ensure proper planning and execution of and quality improvement initiatives to reduce issues to build a stronger Quality driven organization. Generate, analyze and report metrics to demonstrate key aspects of compliance status, escalating issues in a timely manner for earliest resolution, Regulatory Inspections: Facilitates regulatory inspection preparation, management, and follow-up, ensuring thorough management review of compliance topics. Acts as a key representative during inspections and external audits. Ensure ongoing submission and inspection readiness for the respective Medical Affairs teams and related submissions, supporting the preparation and management of regulatory inspections in collaboration with business functions. Provide expert guidance to enable successful inspections. Lead/Support local inspections by providing adequate systems and process support, ensuring seamless execution. Lead lessons learned efforts based on audit findings, inspection results, regulatory intelligence, effectiveness checks, and process improvements, ensuring CAPAs are coordinated and shared to drive standardized responses and continuous learning across the organization. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education: Must have a Bachelor's Degree in Life Sciences . click apply for full job details

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! The Role Genmab is on the lookout for a visionary Director, Platform Owner & Architect - Commercialization Solutions to ignite our next-gen customer-engagement landscape. Nestled within the Data, Digital & AI (DD&AI) organization, you'll serve as the strategic and hands-on guardian of our CRM and allied commercialization platforms that power both field teams and home-office specialists in delivering remarkable experiences to healthcare professionals and patients. Leveraging 12-15 years of deep CRM architecture expertise-ideally spanning Salesforce and Veeva in life-sciences environments-you'll craft and execute a bold roadmap that unleashes data-driven insights, streamlines field operations, and knits our platforms seamlessly into downstream systems and enterprise data ecosystems. This role sits at the intersection of technology, business, and patient impact. We welcome applicants from every background and lived experience; your unique perspective is the catalyst for therapies-and careers-that defy the ordinary. The role will report to the VP, Enterprise Digital Solutions. This role is based out of our Princeton office and requires for you to be on site 60% of the time Responsibilities Vision & Strategy Define and evangelize the long-term platform vision for Salesforce Health Cloud, Veeva CRM, and adjacent technologies and integration patterns. Translate Genmab's "KYSO" ambition into clear architectural principles, standards, and a multi-year delivery roadmap that balances innovation, scalability, and compliance. Technical Leadership Lead, mentor, and grow an inclusive "hub" team of architects, admins, and developers while orchestrating a global network of partner resources. Serve as chief decision-maker on solution design, integration patterns, DevSecOps, and data model governance. Champion API-first, low-code / pro-code coexistence, and automated quality-engineering practices (SFDX, GitLab CI/CD, Tricentis, Copado). Field Medical & Commercial Excellence Partner with business spoke teams to ensure solid alignment and fruition of business needs through solid platform operations and robust feature development, with an eye on seamless user experience. Design intelligent workflows by integration disparate systems towards a more cohesive end-user experience. Integration & Data Fluency Oversee bi-directional integrations with ERP, data lakes, pharmacovigilance, learning, and incentives systems; ensure a single source of truth for customer and product data (MDM/Reltio, Snowflake, AWS Redshift). Drive interoperability with Veeva Vaults, and third-party platforms. Compliance, Risk & Security Embed privacy-by-design and audit-ready controls into every release; own validation documentation and change-control processes. Anticipate and mitigate risks across infrastructure, integrations, data quality, and user adoption. Stakeholder Engagement & Change Enablement Act as the connective tissue between business spoke leaders/admins, and technology teams within the Data, Digital and AI organization. Craft compelling narratives and demos that inspire diverse, cross-functional teams to embrace the art of the possible. Continuous Improvement & Innovation Identify and pilot emerging Salesforce capabilities (Einstein, Data Cloud, Hyperforce) and partner apps that deliver measurable value to patients, providers, and Genmab teams. Track and optimize platform economics; champion citizen-development and community-of-practice initiatives to democratize innovation via a hub and spoke model. Identify and pilot emerging Salesforce capabilities (Einstein, Data Cloud, Hyperforce) and partner apps that deliver measurable value to patients, providers, and Genmab teams. Track and optimize platform economics; champion citizen-development and community-of-practice initiatives to democratize innovation. Requirements Bachelor's degree (or equivalent) in Computer Science, Engineering, or a related technical field; a Master's degree is preferred. 12 +years of hands-on CRM architecture and delivery experience in life-sciences (pharma, biotech, or consulting) Proven leadership of multi-cloud Salesforce implementations (Health Cloud, Sales/Service Cloud, Experience Cloud) Advanced Veeva CRM configuration expertise, including Events Management, Medical Insights, and Align Salesforce Application or System Architect certification Veeva CRM Advanced Admin or equivalent Veeva certifications preferred API-first integration design skills with middleware (e.g. - Informatica, Mulesoft) and data platforms (Snowflake, AWS, Reltio MDM) Command of DevSecOps and CI/CD pipelines using SFDX, GitLab, and automated testing frameworks (Copado, Tricentis) Deep understanding of Medical Affairs and Commercial workflows (MSL call planning, KOL engagement, compliant scientific exchange) and global regulatory frameworks (21 CFR Part 11, GDPR, Sunshine/Open Payments) Demonstrated success building diverse, high-performing teams, driving platform governance, and delivering measurable improvements in field productivity, data quality, and customer insight Minimum of 8 years of experience as an Application Manager, System Administration and/or Business Analyst at a life science or biotech organization, within the commercial organization. Minimum of 5 years of experience in a customer-facing environment working with global stakeholders and team members. Prior knowledge of the pharmaceutical commercial domain in the European market is desirable. Oncology launch experience is preferred. Minimum of 5 years of experience with Veeva, Salesforce, or similar CRM is a must. Strong knowledge of business models, operating models, financial models, cost-benefit analysis, budgeting, and risk management. Familiarity with GxP compliance and European Data Privacy regulations, including GDPR, is a plus. Experience with structured Software Development Lifecycle (SDLC) methodologies. Ability to elicit complex business requirements from both small and large audiences, including business and IT professionals. Proficiency with Office tools, mobile apps, and other IT capabilities expected in a senior IT role. Excellent interpersonal, teamwork, facilitation, and negotiation skills. Strong leadership and influencing abilities. Excellent investigative and technical skills. Proficiency in English, as it is the global language for Genmab. For US based candidates, the proposed salary band for this position is as follows: $177,600.00 $266,400.00 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 . click apply for full job details

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! If you have a passion for vendor oversight and process improvement within clinical trial operations, then this role is for you. This is an office-based hybrid position with the expectation to be onsite at least 60% of your time to foster collaboration and team engagement. Job Description: The Director of CRO Excellence and Process Innovation Lead will play a key operational role in supporting the execution and refinement of the clinical outsourcing model across the development portfolio. This position will focus on the day-to-day oversight of CRO performance, vendor relationship management, governance processes, and the implementation of process improvement initiatives to enhance trial delivery. Reporting to the Senior Director, Head of CRO Excellence and Process Innovation within TSD . Key Responsibilities: Operational Oversight Support the execution of outsourced Phase I-III clinical trials through direct oversight of CROs and functional service providers. Ensure vendor delivery aligns with program timelines, budgets, and quality expectations. Serve as a key point of contact for vendor-related operational issues, escalating unresolved matters as needed through the escalation pathway and governance structure . Vendor Management Manage and maintain operational relationships with CROs, including adherence to governance frameworks and partnership operational manuals. Participate in vendor governance forums such as Operational Committee meetings and provide input into Steering Committee discussions. Contribute to CRO performance evaluations and facilitate resolution of operational issues. Process Optimization Identify opportunities to improve outsourcing processes and contribute to the development and rollout of new operational best practices. Collaborate with Development Operations / Trial Operations and other functional groups to streamline trial delivery and reduce operational inefficiencies. Support process mapping, documentation, and implementation of continuous improvement initiatives. Team Support and Collaboration Act as a mentor and resource to Global Trial Leaders/ Clinical Trial Managers and other team members involved in vendor oversight. Provide input into team development efforts, including training and knowledge sharing related to outsourcing and governance practices. Collaborate cross-functionally to align outsourcing strategy execution and process standards. Cross-Functional Partnership Work closely with colleagues in Clinical Strategy, Development Operations, Regulatory Affairs, and external partners to align operational execution with clinical development goals. Foster collaborative relationships with vendors to ensure transparent communication and proactive issue management. Compliance and Governance Ensure vendor-conducted activities are compliant with ICH-GCP, regulatory requirements, and internal SOPs (where applicable) . Monitor and support alignment between vendor processes and Genmab's quality systems. Participate in audits and inspections as needed, ensuring preparedness of outsourced trial components. Qualifications: Experience : 10+ years in clinical trial operations, with experience in vendor/CRO oversight and outsourcing governance. Education : Bachelor's degree in life sciences, healthcare, or related field (advanced degree preferred). Knowledge : Strong understanding of clinical trial processes, ICH-GCP, and regulatory standards. Vendor Management : Proven experience managing CROs and functional vendors across global studies. Process Improvement : Demonstrated ability to identify operational inefficiencies and contribute to solution development. Team Collaboration : Ability to work in matrixed environments and foster productive cross-functional partnerships. Communication : Excellent organizational, interpersonal, and communication skills. For US based candidates, the proposed salary band for this position is as follows: $186,960.00 $280,440.00 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, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO ) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit and follow us on LinkedIn and X. Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (). Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.

At Genmab, we're committed to building extra not ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose. The Role As our project portfolio at Genmab continues to grow, we are expanding our team and seeking a Team Lead, Associate Director to join the Regulatory Affairs CMC (RA CMC) team. In this role, you will lead a sub-team within RA CMC while also actively contributing to project work, balancing leadership responsibilities with hands-on involvement in regulatory activities, ensuring both strategic oversight and direct impact. We offer an exciting and challenging opportunity in a dynamic, global company, where you will collaborate with talented and experienced colleagues in Regulatory Affairs and Genmab's CMC organization. Our team is strong and supportive, fostering a culture of collaboration and trust, making it a valued partner to the CMC organization. The RA CMC team at Genmab consists of 11 experienced and dedicated colleagues. As part of our growth, we are now looking for a Team Lead to guide a sub-team within RA CMC while also actively contributing to regulatory projects as a member of the broader RA CMC team. This role is based in Copenhagen and reports directly to the Senior Director of RA CMC, who is located in Denmark. Responsibilities The responsibilities of the role will include, but are not limited to: Lead, mentor, and develop team members to help them perform at their best, fostering a high-performing and collaborative team environment. Provide strategic direction and oversight for the sub-team within RA CMC, ensuring alignment with broader regulatory and business objectives. Develop and execute sound and robust global regulatory CMC strategies for biological products during early and late-stage development, as well as throughout the product lifecycle. Support team members in navigating regulatory challenges and decision-making, ensuring high-quality regulatory deliverables. Collaborate with cross-functional peers to facilitate and optimize product development. Plan, review, and prepare CMC documentation for clinical applications, marketing authorization applications, and health authority briefing packages. In collaboration with CMC, plan and prepare responses to health authority information requests. Plan and prepare post-approval applications. Provide advice and guidance on EU, US, and selected worldwide regulatory legislation for CMC topics. Liaise and negotiate with global health authorities on RA CMC topics, representing Genmab in meetings and interactions with health authorities. Stay informed on evolving regulatory laws, guidance, and industry trends, ensuring best practices are implemented within the team. Requirements Master of Science in pharmacy, engineering or equivalent. Minimum of 10 years of industry experience within RA CMC, with a strong understanding of compliance and biologics. Experience with leadership. A track record in moving therapeutic products through various stages of development. Experience with lifecycle management. Proficiency in English communication (verbal and written). Moreover, you meet the following personal requirements: You have strong leadership skills and can inspire and motivate others to achieve common goals. You lead by example, promoting accountability, integrity, and excellence in your work. You are comfortable making decisions, providing guidance, and supporting team members in a dynamic environment. You foster a culture of continuous learning, coaching, and professional development within the team. You have excellent collaboration and communication skills. You thrive when challenged and enjoy working in cross-functional teams. You have a quality mindset and can prioritize your work in a fast-paced and changing environment. You are result-oriented and committed to contributing to the overall success of Genmab. 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. About Genmab Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO ) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. Our commitment to diversity, equity, and inclusion We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website. Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice ().

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! Director of Competitive Intelligence About Us Genmab is an international biotechnology company dedicated to the invention and development of differentiated human antibody therapeutics for the treatment of cancer and other serious diseases. Our mission is to improve the lives of patients by creating and developing innovative and differentiated antibody products, with a commitment to bringing them to market. The Role We are seeking a Director of Competitive Intelligence (CI) to lead the development, integration, and execution of strategic intelligence capabilities across Genmab's global oncology portfolio. In this critical role, you will act as a strategic advisor and insight generator-delivering timely, actionable competitive insights that shape commercial, clinical, and R&D decision-making. You will lead high-impact initiatives across pipeline and marketed assets (e.g., Epkinly , Acasunlimab , and Rina-S ) and develop CI capabilities and processes that scale across functions, regions, and stages of development. Reporting to the Global Head of Business Insights & Analytics, you will serve as a cross-functional collaborator and key voice in strategy development. Key Responsibilities Strategic Leadership: Develop and execute a global CI strategy aligned with brand, disease area, and portfolio objectives. Act as a strategic thought partner to senior leadership across Commercial, R&D, and Medical Affairs. Lead and manage a team (direct or matrixed) of CI professionals and vendors to deliver high-value insights. Global Market Monitoring: Track and analyze competitor activities across commercial, clinical, regulatory, and policy domains. Maintain competitive timelines, clinical trial intelligence, and product profiles across geographies (US, EU, JP). Deliver early warning intelligence on disruptive market or pipeline events. Decision Influence: Lead competitive simulations, war games, and scenario planning exercises. Translate intelligence into strategic options and evidence-based recommendations for executive stakeholders. Support brand planning, launch strategy, lifecycle planning, and BD assessments. Internal Collaboration & Enablement: Serve as a catalyst for cross-functional alignment and decision-making grounded in external insight. Build and nurture a network of internal subject matter experts and CI champions across functions. Develop and maintain CI communication channels, knowledge-sharing platforms, and dashboards. Operational Excellence & Ethics: Own CI budget, resource allocation, vendor oversight, and project management. Implement best practices for CI collection, synthesis, and dissemination. Ensure all CI activities adhere to Genmab's legal and ethical standards for competitive intelligence. Key Accountabilities Portfolio & Brand Support: Lead CI for prioritized pipeline assets and in-market brands across solid tumors and hematologic indications. Provide strategic CI inputs into brand strategy, positioning, and launch planning efforts. Generate insights that impact patient segmentation, treatment algorithms, market shaping, and competitor defense. Enterprise Impact: Enable Genmab's executive leadership to make faster, smarter decisions informed by external intelligence. Drive competitive readiness across critical functions. Serve as a key intelligence partner for early R&D and clinical teams exploring asset advancement or indication expansion. Qualifications Education: Bachelor's degree in life sciences, business, or health sciences required. Advanced degree (MBA, PhD, PharmD) strongly preferred. Experience: 10+ years of experience in CI, Market Research, or Strategy in the biotech/pharmaceutical industry. Significant oncology and/or hematology therapeutic area expertise required. Demonstrated experience influencing clinical or commercial strategy at a global level. Strong cross-functional leadership and ability to work across geographies and disciplines. Prior experience leading CI teams or managing large-scale CI programs preferred. Why Join Genmab At Genmab, our employees work with purpose and integrity to advance innovative therapies that make a meaningful difference for cancer patients. We foster an inclusive, collaborative environment built on respect, accountability, and scientific rigor. You will join a company at the cutting edge of oncology science and help shape how we compete, adapt, and lead in a dynamic global market. This role provides a unique opportunity to work with visionary leaders, contribute to enterprise strategy, and influence the direction of our pipeline and brands. For US based candidates, the proposed salary band for this position is as follows: $188,000.00 $282,000.00 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, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO ) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit and follow us on LinkedIn and X. Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (). Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year . click apply for full job details

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