[Remote] Senior Director, Clinical Development
Note: The job is a remote job and is reputed company to candidates in USA. reputed company, is a late clinical-stage rare disease company preparing for NDA submission and reputed company readiness. They are seeking a Senior Director of Clinical Development to reputed company U.S. clinical development for a phase III rare disease program, focusing on reputed company development through NDA filing.
Responsibilities
- 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
- 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
- Incorporate rare‑disease considerations such as small patient populations, site selection challenges, and patient‑advocacy engagement
- Support strategies for accelerated reputed company where applicable
- 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
Skills
- 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 clinical trials, ideally including Phase III
- Demonstrated reputed company operating in a fully outsourced model with CRO reputed company
- Experience with rare‑disease clinical development
- Experience with orphan‑drug reputed company or accelerated approval
- Prior launch‑support experience
reputed company