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Senior Director Clinical Safety
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. In addition to a strong portfolio of medicines for cardiovascular diseases, 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.
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.
Responsibilities
- Depending on the status of development of the compound, lead and medical-scientifically direct a team of physicians responsible for a compound/product including project management, project-specific training and coaching of team members, review of team output cross-functional
- Effectively represent the CSPV on the Global Product Team providing the safety support and serving as the primary point of contact.
- Review and analyze data from clinical trials for the prompt identification of safety signals. Review and evaluate serious adverse event reports from clinical trials 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 (to agreed timelines.
- 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.
- MD Board certification or eligibility required
- 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
Physical Requirements
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.
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.
Recommended Skills
- Biostatistics
- Clinical Development
- Clinical Trials
- Clinical Works
- Communication
- Consulting
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