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
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Serve as the senior clinical leader and clinical decisionmaker for the U.S.
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Develop and refine the clinical development plan for late‑stage development and registration.
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Integrate indication specific considerations into trial design and evidence generation.
Clinical Trial Oversight (Fully Outsourced Model)
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Oversee all aspects of Phase III execution through CROs and external vendors.
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Ensure scientific integrity, protocol adherence, and high‑quality data delivery.
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Provide medical and scientific oversight for safety monitoring, eligibility decisions, and protocol deviations.
Rare‑Disease Clinical Development
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Incorporate rare‑disease considerations such as small patient populations, site selection challenges, and patient‑advocacy engagement.
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Support strategies for accelerated pathways where applicable.
Cross‑Functional Leadership
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Partner closely with Regulatory, CMC, Quality, and Commercial to ensure clinical insights inform company strategy.
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Represent Clinical Development at internal governance meetings and with external stakeholders.
Qualifications:
Must‑Have
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Minimum of BS in Biology, Chemistry, or related discipline.
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Advanced degree is highly preferred.
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10+ years of clinical development experience in the specialty biopharmaceutical industry.
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Experience leading late‑stage clinical trials, ideally including Phase III.
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Demonstrated success operating in a fully outsourced model with CRO oversight.
Nice‑to‑Have
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Experience with rare‑disease clinical development.
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Experience with orphan‑drug pathways or accelerated approval.
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Prior launch‑support experience.
TSP is an affirmative action/equal opportunity employer (Minorities/Females/Veterans/Disabled)
