Senior Director, Clinical Development
TSP, a Syneos Health company · United States · 3 wk ago
RemoteRemoteAnalystFull-time
About the role
Late clinical-stage rare disease company preparing for NDA submission and commercial readiness is seeking a Senior Director of Clinical Development.
Key Responsibilities
- Serve as the senior clinical leader and clinical decisionmaker for the U.S.
- Develop and refine the clinical development plan for late-stage development and registration.
- Integrate indication-specific considerations into trial design and evidence generation.
- Oversee all aspects of Phase III execution through CROs and external vendors.
- Ensure scientific integrity, protocol adherence, and high-quality data delivery.
- Provide medical and scientific oversight for safety monitoring, eligibility decisions, and protocol deviations.
- Cross-functional leadership, partnering closely with Regulatory, CMC, Quality, and Commercial to ensure clinical insights inform company strategy.
- Represent Clinical Development at internal governance meetings and with external stakeholders.
Qualifications
- Must-have: Minimum of BS in Biology, Chemistry, or related discipline. Advanced degree is highly preferred.
- 10+ years of clinical development experience in the specialty biopharmaceutical industry.
- Experience leading late-stage clinical trials, ideally including Phase III.
- Demonstrated success operating in a fully outsourced model with CRO oversight.
- Nice-to-have: Experience with rare-disease clinical development, experience with orphan-drug pathways or accelerated approval, prior launch-support experience.