Job Description
Description About the Role Late clinical‑stage rare disease company preparing for NDA submission and commercial readiness is seeking a Senior Director of Clinical Development to lead U.S clinical development for a phase III rare disease program, developing and driving strategy through NDA filing. This is a hands‑on, strategic, and execution‑focused role ideal for someone who thrives in small biotech environments and has an expertise in small molecule rare disease programs. Key Responsibilities Clinical Strategy & Leadership 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. Clinical Trial Oversight (Fully Outsourced Model) 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. Rare‑Disease Clinical Development Incorporate rare‑disease considerations such as small patient populations, site selection challenges, and patient‑advocacy engagement. Support strategies for accelerated pathways where applicable. Cross‑Functional Leadership 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. 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. TSP is an affirmative action/equal opportunity employer (Minorities/Females/Veterans/Disabled)