$100K — $150K *
The Risk Management Director will coordinate and lead the development and implementation of integrated project/product risk management strategies aimed at achieving the optimum benefit-risk for Development Sankyo’s development compounds. 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. Specific responsibilities will vary depending on the stage of development of assigned projects (i.e., Phase I through commercialization).
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).
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
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.
Valid through: 2/18/2021