Senior Director, Clinical Development

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.

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