Director, Clinical Safety

2 weeks ago

Basking Ridge, United States Hire Talent Full time

Job Title: Director, Clinical Safety
Job Schedule: Candidate can work 100% remote for duration of assignment; might need to come into office for occasional meetings (once a quarter). Candidates need to be EST based.
The Director, Clinical Safety, will be a product safety lead or part of a product safety team, and be responsible for overall product safety strategy or specific areas of safety surveillance and risk management, and provide safety leadership including but not limited to clinical studies, post-marketing surveillance, signal detection and management, important safety topics, and regulatory submissions. This individual will ensure proactive safety monitoring and risk management through the Safety Management Team framework. This individual will use strong leadership and communication skills to ensure effective collaboration across development functions and sites. The individual assuming this role may function as a key member of the Global Product 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).
Responsibilities - Depending on the status of development of the compound, lead and medical-scientifically direct a team of junior
physicians and scientists responsible for a compound/product safety, including project-specific training and coaching of team members and review of team output cross-functionally. - Effectively represent the CSPV on the Global Product Team or specific sub-teams such as clinical study team and submission team, providing the safety leadership and serving as the primary point of contact. - Review and analyze data from
clinical trials, post-marketing and other relevant sources for the prompt identification of safety signals. Review and evaluate serious adverse event reports from clinical trials or post-marketing 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 on time. - Coordinate and participate actively in safety-related regulatory interactions (e.g., regulatory meetings, post-approval commitments).

4 or More Years of experience in the pharmaceutical industry, regulatory agency or academia, with exposure to drug development, clinical
pharmacology, and/or epidemiology.

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