Senior Director, Clinical Safety MD

Job Summary

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.

• Depending on the status of development of the compound, lead and medical‑scientifically direct a team of physicians and scientists responsible for a compound/product including project‑specific training and coaching of team members and review of team output cross‑functionally.
• Effectively represent the CSPV on the Global Product Team or other cross‑functional teams providing the safety leadership and serving as the primary point of contact.
• Review and analyze data from clinical trials, post‑marketing and other relevant sources for the prompt identification of safety signals.
• Lead internal and external (especially regulatory, but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned projects/products.
• Define and implement strategies and action plans for identifying and managing risks throughout the product life cycle.
• Effectively coordinate and manage available resources in developing and delivering high‑quality safety evaluation related documents/deliverables on time.
• Coordinate and participate actively in safety‑related regulatory interactions (e.g., regulatory meetings, post‑approval commitments).

• MD is required (board certification or eligibility).
• 6 or more years of experience in the pharmaceutical industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology.
• Expertise in oncology highly preferred.

Travel:
Some travel both domestic and global will be required.

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$ - USD$