Director, Clinical Safety

Job Summary: We currently have an opening for a Director, Clinical Safety in our Edison, New Jersey location. This person will coordinate and lead the development and implementation of integrated product pharmacovigilance and risk management strategies aimed at achieving the optimum benefit-risk for Daiichi-Sankyo's oncology compounds in development. This individual will chair the Safety Review Team meetings for Phase 2 and 3 molecules, reviewing the evolving safety profile of oncology compounds, identifying potential safety signals through single case and aggregate analysis. In addition, this individual will represent the Integrated Team as the interface with external Data Safety and Monitoring Boards. This individual will use strong leadership and communication skills to successfully coordinate resources and ensure effective collaboration across development functions and sites. The individual assuming this role will function as a key member of the Integrated Project 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.). Responsibilities: You will develop processes and procedures for identifying and evaluating risk management issues for compounds in development. Effectively represent Risk Management department on the development Integrated Project Team providing risk management 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 management assessment of assigned projects/products. Define and implement strategies and action plans for managing risk management issues throughout the product life cycle. Effectively coordinate and manage available resources in developing and delivering high-quality risk management documents/deliverables (e.g., Risk Management Plans) to agreed timelines. Coordinate and participate actively and influentially in regulatory risk management activities (e.g., regulatory meetings, post-approval commitments). Qualified candidates will have a MD (or PhD in a relevant scientific discipline), Board certification or eligibility. 3-5 years experience in the pharmaceutical industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology. Senior Director 7- 10 years. Proven ability to effectively lead cross-functional teams and to influence where direct reporting line relationships do not exist. Ability to review and analyze data and communicate complex information and analyses to a variety of scientific and non-scientific audiences. Proven ability to think creatively and to develop strategic plans that demonstrate sound judgment. Experience working cross-culturally in a global pharmaceutical environment.
Must be willing to travel 10-20% of the time.