Executive Director, Head of Safety Science

This job must be based at our HQ in Basking Ridge, NJ location. Relocation benefits will be provided for qualified hire who meets requirements. We do have a hybrid work model. Join a Legacy of Innovation 110 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 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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.SUMMARYThe Executive Director, Head of Safety Science, will lead a group of safety scientists across regions to collaborate with safety physicians and other functions in all aspects of safety activities, including safety surveillance and risk management in clinical studies, regulatory submissions, post marketing safety surveillance and risk management, and aggregate reports.The incumbent will hire and develop talents of safety scientist, refine or expand the scope of global safety scientists as the organization grows in collaboration with other functions, coordinate and prioritize scientist resource for important programs, provide senior safety leadership and guidance for complicated safety issues across DS portfolio including both compounds in clinical development and marketed products.

The successful candidate will collaborate with sub-functions in CSPV and other functions across the company to ensure alignment. This senior role works closely with other CSPV Leadership to develop and align processes to support departmental objectives.

ROLE RESPONSIBILITIES

• A member of DSI CSPV and Global Medical Safety leadership team develops, or uses expertise to support the development of, strategies and objectives for DSI CSPV and Global Medical Safety in safety science, and ensure these are aligned to broader DS goals and objectives
• Partner with other leadership members in managing DSI CSPV HR related matters including performance review and departmental talent development
• Line management and senior leadership accountabilities in safety science. Manage a team of safety scientists; recruit, develop and retain talents; coach, mentor, and influence team members and other members in CSPV.
• Ensure adequate resource for important programs, working closely with scientist leads in other regions to collaborate resource and talent development. Ensure full implementation of all CSPV strategic change programs in safety science group.
• Scientific lead role. Provide oversight and guidance for all scientific activities within the group of safety science, including global work by scientists in other regions. May manage complicated safety issues directly related to safety surveillance, risk management and communication strategy, regulatory submissions, and aggregate reports.
• Lead projects to improve processes within CSPV or develop and introduce new technologies and approaches at global level
• Build team capabilities & maintain a high degree of understanding and awareness of internal and external trends in safety science and share this with leadership and team members as appropriate.
• Build networks with other teams/functions and external stakeholders to learn about new developments, leverage opportunities and share best practices. Refine/expand global roles and responsibilities of safety scientists as the organization grows and business needs evolve.
• Compliance responsibilities. Ensure that all work of the group is compliant with Good Clinical and Pharmacovigilance Practice and all relevant internal and external regulations and standards

Education Qualifications (from an accredited college or university)

• A PharmD or PhD in relevant scientific field is required

Experience Qualifications

• Must have 10+ years of professional experience within clinical development or clinical safety/post marketing safety in the pharmaceutical industry
• 4 + years of professional experience working within clinical safety/post marketing safety in the pharmaceutical industry
• 4+ years of proven, direct leadership of direct reports, in particular leading safety scientist teams in clinical studies, regulatory submissions, aggregate reports and post-marketing surveillance and risk management required
• Must possess excellent communication skills both written and oral
• Must have demonstrated strong project management analytic skills
• Must have strong track record of demonstrated organizational leadership skills
• Must have extensive knowledge of the latest technical and regulatory development

Travel

• This role requires up to 10% domestic & global travel.

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.