Sr Director Clinical Safety (Little Falls)
Compensation: $111,680.00 - $166,760.00 /year *
Employment Type: Full-Time
Industry: Executive Management
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About Daiichi Sankyo Cancer Enterprise
The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.Job Summary
Position independently and effectively leads SMTs at any stage of development and is recognized as the product safety expert for assigned products at any stage of development. This position spearheads the development and implementation of global and integrated project/product risk management strategies, including developing processes/procedures to identify and evaluate safety signals for products. This position soundly and thoroughly integrates safety data from all sources to perform safety assessments, and to determine the safety profile of assigned products. In doing so, this position interacts with internal and external stakeholders to globally vet and communicate safety issues and serves on the TR-PT/IPT. Finally, this position reviews and approves safety documents and works on complex safety problems with minimal managerial review, such as the approach to safety assessment and regulatory response for a novel and serious safety signal. ResponsibilitiesSafety Expert - Overall:
Serves as the physician responsible for determining the safety profile and for leading SMTs for assigned products from development through LCM. Defines the risk component of the B/R assessment. Is the primary author for the RMP. Maintains expert knowledge of regulations and guidance related to safety reporting and safety surveillance.Safety Expert - Signal Identification:
Creates signal identification methods for global products with minimal managerial input. Mentors, trains, and supervises junior staff involved in signal identification efforts.Safety Expert - Signal Evaluation:
Creates the approach to signal evaluation for global products with minimal managerial input. Supervises junior staff during signal evaluation efforts. Integrates and evaluates data to deliver comprehensive conclusions.Safety Expert - Risk Mitigation & Communication:
Is critically involved in creating, proposing and implementing risk mitigation actions for global products. Gains internal and external buy-in. Globally communicates product safety information to all internal stakeholders and works closely with Public Affairs to formulate communication for external stakeholders.Reports and Submissions:
Provides comprehensive and integrated reviews of safety sections in documents containing safety information. First authors white papers involving safety. Provides medical review for US and EU periodic reports. Is the primary owner of the RMP.Qualifications
Education and Experience
- Requires MD degree
- 5 years of relevant experience and board eligibility
Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All 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.Job Title
Sr Director Clinical SafetyCity
Basking RidgeFunctional Area
Associated topics: design, engineering, manufacture, product, product manager, production, program manager, quality
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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