Sr. Director, Benefit-Risk Management and Surveillance

Sr. Director, Benefit-Risk Management and Surveillance Department/Division: Biotech/R&D/Science Job Type: Full Time, Employee Company: Vertex Pharmaceuticals Inc. Location: US-MA-Boston Job Reference Id: 1225   Description: Posting Title: Sr. Director, Benefit-Risk Management and Surveillance Department /Division: Clinical Safety Classification: Clinical Research Location: Cambridge, MA Required Education: M.D . Relocation: Yes Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company's strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex's product pipeline is focused on viral diseases, inflammation, autoimmune diseases, cancer, pain and bacterial infection. Position Overview: The Senior Director, Benefit-Risk Management and Surveillance will be responsible for the overall safety and Benefit/Risk Management strategy for Vertex products. He/she will develop and implement strategy for safety processes and risk management activities. He/she will serve as the expert to internal staff and external constituents, providing benefit/risk management input. He/she will also be responsible for the assessment of benefit-risk information, evaluation of safety signals and formulation of responses to regulatory inquiries. He/she will ensure effective collaboration across functions, and ultimately be responsible for coordinating resources, as well as maintaining a validated safety data computer system. Key Responsibilities: • Build the Risk-Benefit Management & Surveillance strategy at Vertex. • Responsible for the proper conduct of Risk-Benefit Management Meetings for investigational drugs • Assure, in conjunction with Regulatory Affairs, compliance with regulatory reporting requirements for safety reporting in clinical trials, domestically and internationally. • Provide expertise for developing procedures to capture, manager and report clinical trial safety data. • Participate in protocol development, specifically protocol design and statistical analysis plans. • Serve as expert on product teams to provide guidance regarding safety and Risk-Benefit related issues. • Interact with key opinion leaders in the field and identify appropriate investigators and study sites to conduct clinical trials. Minimum Requiremements • M.D. required • 8+ years of pharmaceutical pharmacovigilance experience. • Solid knowledge of general medicine and clinical practice, evidenced by medical training and/or medical practice experience. • Strong knowledge of safety reporting activities, guidelines and pharmaceutical industry compliance activities. • Excellent verbal and written communication skills. Strong leadership skills, and experience working in a matrix environment. Apply Now