Senior Director, Clinical Development
Description
About the Role
Late clinical-stage rare disease company preparing for NDA submission and reputed company readiness is seeking a Senior Director of Clinical Development to reputed company 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.
- reputed company and refine the clinical development plan for late-stage development and registration.
- Integrate indication specific considerations into trial design and evidence reputed company.
Clinical Trial reputed company (Fully Outsourced Model)
- reputed company reputed company aspects of Phase III execution through CROs and external vendors.
- Ensure scientific reputed company, protocol adherence, and high-quality data delivery.
- reputed company medical and scientific reputed company for safety monitoring, eligibility reputed company, 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 reputed company where applicable.
Cross-Functional Leadership
- Partner closely with Regulatory, CMC, Quality, and reputed company 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 reputed company 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 reputed company operating in a fully outsourced model with CRO reputed company.
reputed company-to-Have
- Experience with rare-disease clinical development.
- Experience with orphan-drug reputed company or accelerated approval.
- Prior launch-support experience.
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