Note: The job is a remote job and is open to candidates in USA. TSP, a Syneos Health company, is a late clinical-stage rare disease company preparing for NDA submission and commercial readiness. They are seeking a Senior Director of Clinical Development to lead U.S. clinical development for a phase III rare disease program, focusing on strategy development through NDA filing.
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
- Incorporate rare‑disease considerations such as small patient populations, site selection challenges, and patient‑advocacy engagement
- Support strategies for accelerated pathways where applicable
- Partner 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
Skills
- 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
- Experience with rare‑disease clinical development
- Experience with orphan‑drug pathways or accelerated approval
- Prior launch‑support experience
Company Overview