Senior Director of Clinical Safety and Risk Management
3 days ago
Daiichi Sankyo Inc. is a global pharmaceutical company dedicated to creating innovative therapies to improve healthcare outcomes. With a rich legacy of innovation and a robust pipeline of promising new medicines, we are committed to addressing unmet medical needs and improving the lives of people worldwide.
Job SummaryWe are seeking a highly skilled and experienced Senior Director of Clinical Safety and Risk Management to join our team. As a key member of our Global Product Team, you will lead the development and implementation of integrated project/product risk management strategies to achieve the optimum benefit-risk for our development compounds.
Key Responsibilities- 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 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 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, such as regulatory meetings and post-approval commitments.
- MD Board certification or eligibility required.
- 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.
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.
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