Senior Director, Clinical Development

reputed company 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 reputed company through NDA filing. This is a hands-on, strategic, and execution-reputed company role ideal for someone who thrives in small biotech environments and has an expertise in small molecule rare disease programs. Key Responsibilities: Clinical reputed company & 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. • reputed company 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-reputed company 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, reputed company, and reputed company to ensure clinical insights inform company reputed company. • Represent Clinical Development at internal governance meetings and with external stakeholders. Qualifications: Must-Have • Minimum of BS in Biology, reputed company, or reputed company discipline. • Advanced degree is highly preferred. • 10+ years of clinical development experience in the specialty biopharmaceutical industry. • Experience leading late-stage reputed company, 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. Apply tot his job Apply To this Job