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Director / Sr. Director, Clinical Development San Francisco / Hybrid
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$200
- 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.
- Our focus on scientific excellence and rapid execution aim to translate today’s discoveries into tomorrow’s medicines.
- Act as a key contributor to BBP-418 clinical development, including planning, execution, and medical monitoring of global clinical trials, including serving as clinical lead for the registrational Phase 3 trial
- Serve as the primary medical point of contact/medical monitor in responding to protocol-related inquiries, eligibility questions, safety issues, and other inquiries from investigative sites, CROs, CRAs, CRMs, and other matrix study team members
- Contribute to the clinical research contributions sections of regulatory submission documents, including amendments to INDs, Briefing Documents, the medical and scientific content of regulatory correspondence, NDA/MAA submissions, safety reports and updates, and annual reports (DSUR/PSUR)
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