Executive Director, Head of CoE, Global Medical Safety
At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
Job SummaryThe Executive Director, Head of Center of Excellence (CoE), Global Medical Safety will oversee a team of safety physicians and scientists across various regions, offering guidance and support to each product safety team in critical areas such as individual case medical review, risk management, aggregate safety reports, and translational medical safety. This role requires the individual to bring the latest knowledge in these fields, ensuring high quality and efficiency. This role will be responsible for recruiting and developing the CoE team, refining or expanding its scope as the organization evolves in collaboration with other departments, and coordinating and prioritizing CoE resources for key programs. The role will also provide senior safety leadership and guidance on complex issues across the DS portfolio, including both compounds in clinical development and marketed products. The successful candidate will work in collaboration with subfunctions within CSPV and other departments across the company to ensure alignment. This senior role will involve close cooperation with other CSPV Leadership to develop strategy and harmonize processes that support the department's objectives. Responsibilities
As a member of DSI CSPV and Global Medical Safety leadership team responsibilities will include:
- Develop or leverage expertise to support the creation of strategies and objectives for DSI CSPV and Global Medical Safety, including the CoE, ensuring alignment with the broader DS goals and objectives.
- Collaborate with other leadership members to manage DSI CSPV HR-related matters, including performance reviews and departmental talent development. Line management and senior leadership accountabilities in CoE
- Lead a team of safety physicians and scientists by recruiting, developing, and retaining talent; coach, mentor, and influence team members within the CoE as well as other members of CSPV.
- Ensure sufficient resources for key programs; collaborate closely with team leads in other regions to coordinate resources and talent development.
- Ensure the full implementation of all CSPV strategic change initiatives within the CoE.
- Refine and expand the global roles and responsibilities of the CoE as the organization grows and business needs evolve.
- Ensure the CoE's continuous operational execution and excellence by applying best practices in accordance with regulatory requirements and guidelines worldwide, and in alignment with the
- CSPV governance and operating model. Provide medical and scientific guidance to teams
- Provide oversight and guidance for all medical and scientific activities within the CoE group, including the global efforts of teams in other regions.
- May directly manage complex safety issues related to individual case review, risk management, translational medical safety, and aggregate safety reports, including:
- Ensure that adverse events are evaluated accurately and promptly, including clinical assessments to determine the seriousness, causality, and expectedness of the adverse event in relation to the drug.
- Ensure all relevant data and findings are incorporated into comprehensive safety reports as required by all regulatory authorities.
- Ensure a robust risk management process with appropriate tools, serving as the expert in risk management for product safety teams.
- Prioritize areas for translational medical safety and make a meaningful impact on clinical development at the program level.
- Lead projects to enhance processes within CSPV, including the CoE, and/or to develop and implement new technologies and approaches at a global level.
- Maintain a high level of understanding and awareness of internal and external scientific and regulatory trends in these four areas, and communicate these insights to leadership and team members as appropriate.
Establish networks with other teams/functions and external stakeholders to stay informed about new developments, leverage opportunities, and share best practices.
- Compliance responsibilities
Ensure that all activities of the CoE group comply with Good Clinical and Pharmacovigilance Practices, as well as all relevant internal and external regulations and standards.
Qualifications
Education Qualifications
An MD is required. A combination of an MD/PhD preferred.
Experience Qualifications
- 10 or more years of relevant experience in clinical development or clinical safety/post marketing safety in the pharmaceutical industry required
- At least 5+ years of experience in clinical safety/post marketing safety in the pharmaceutical industry required
- Demonstrated people leadership/management experience required
- Experience in leading safety physicians and scientists in individual case medical review, aggregate reporting, risk management, and/or translational research is preferred
- Must have excellent communication, project management, writing and analytic skills
- Strong organizational leadership skills
- In-depth understanding of the most recent technical and regulatory advancements
Travel Requirements
Ability to travel up to 10% of the time.
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:
USD$312,600.00 - USD$521,000.00