Description About the RoleLate 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.
