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Director / Sr. Director, Head of TMF Operations
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$205,000 - $260,000 a year
Full-time
- Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.
- The Director/Sr. Director, Trial Master File (TMF) Operations is accountable for the leadership of the TMF organization, inclusive of TMF technology & systems, TMF operations, and TMF inspection readiness.
- They are responsible for TMF process development and implementation and will ensure processes are designed to support the business and TMF needs across the entire Research & Development (R&D) organization of Eidos and BridgeBio. Implementing appropriate controls, standards, and metrics to ensure oversight and compliance in the short and long term.
- Leads TMF team in establishing strategic direction and operational management of TMF, including, process renovation, system & technology, inspection readiness, and outsource & vendor governance
- Establish, lead and chair of TMF Governance forum - responsible communication, escalation and alignment of all aspects pertaining to the TMF and collaboration cross functionally with relevant key stakeholders
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