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Director, Medical Review - Basking Ridge, United States - Daiichi Sankyo
Description
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 16,000 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.
Summary
The Director, Clinical Safety, will be a product safety lead or part of a product safety team, and be responsible for overall product safety strategy or specific areas of safety surveillance and risk management, and provide safety leadership including but not limited to clinical studies, post-marketing surveillance, signal detection and management, important safety topics, and regulatory submissions. This individual will ensure proactive safety monitoring and risk management through the Safety Management Team framework. This individual will use strong leadership and communication skills to ensure effective collaboration across development functions and sites. The individual assuming this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments to strategically manage benefit-risk throughout the lifecycle of the drug. Specific responsibilities will vary depending on the stage of development of assigned projects (i.e., Phase I through commercialization).
Responsibilities
- Depending on the status of development of the compound, lead and medical-scientifically direct a team of junior physicians and scientists responsible for a compound/product safety, 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 specific sub-teams such as clinical study team and submission team, 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. Review and evaluate serious adverse event reports from clinical trials or post-marketing for completeness, accuracy, expectedness and relatedness.
- 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).
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
- MD Board certification or eligibility required
Experience Qualifications
- 4 or More Years of experience in the pharmaceutical industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology 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.
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