Senior Director, Clinical Development

TSP, a Syneos Health company; United States; On-site; USD 150,000 - 200,000; Full time

Job summary

TSP, a Syneos Health company, is seeking a Senior Director of Clinical Development to lead U.S. clinical development for a phase III rare disease program. The role involves developing strategies for NDA filings and executing clinical oversight through CROs.

The ideal candidate will have over 10 years of clinical development experience, preferably in a biopharmaceutical environment, and a minimum BS in Biology or Chemistry. This position is essential for advancing clinical strategies in the rare disease sector.

Qualifications

• 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.

Responsibilities

• Serve as the senior clinical leader and clinical decisionmaker for the U.S.
• Oversee all aspects of Phase III execution through CROs.
• Integrate rare-disease considerations into trial design and evidence generation.

Skills

Clinical development experience

Leadership in clinical trials

Biological sciences knowledge

Experience with CROs

Education

BS in Biology or Chemistry

Advanced degree

Job 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.

TSP is an affirmative action/equal opportunity employer (Minorities/Females/Veterans/Disabled)