Senior Medical Director, Clinical Development

Senior Medical Director Clinical Development

Fully Remote

Compensation: $260,000-300,000 + bonus + Lucrative RSU package

Company Summary:

Our client is a small, gastrointestinal‑focused biopharmaceutical company entering a pivotal stage of growth. The organization has already successfully commercialized a blockbuster therapy, providing the unique advantage of operating as a revenue‑generating, financially stable company while still maintaining the agility, innovation, and close‑knit culture of a smaller biotech.

Building on its commercial success, the company is now advancing its next major program in the GI therapeutic area. As it continues to expand its pipeline and strategic capabilities, the organization is seeking experienced clinical development leadership to help drive its key programs forward. This is a high‑visibility environment where leaders play a central role in shaping clinical strategy, overseeing trial execution, and driving cross‑functional alignment to support future clinical and commercial success.

Primary Responsibilities:

• Provide strategic and hands‑on leadership across all clinical development activities.
• Develop, refine, and maintain the Clinical Development Plan (CDP) in alignment with program and corporate objectives.
• Integrate regulatory, safety, medical, and operational perspectives into clinical strategy and execution.
• Apply innovative, cross‑therapeutic, and data‑driven thinking to guide program decision‑making.
• Lead the design and development of core clinical documents, including protocols, SAPs, investigator brochures, and clinical study reports.
• Provide medical oversight to ensure patient safety, scientific integrity, and high‑quality data generation.
• Analyze, interpret, and communicate clinical data, including implications for study progression and program strategy.
• Educate and mentor internal teams, study investigators, and external partners to ensure alignment and execution excellence.
• Contribute to scientific publications, presentations, and thought‑leadership initiatives.
• Participate in regulatory meetings and contribute to the development of briefing materials.
• Represent the company at scientific conferences, advisory boards, and other key external engagements.
• Foster effective partnerships across R&D, including regulatory, clinical operations, biostatistics, safety, and medical affairs.
• Influence and align diverse stakeholder groups to drive forward complex program objectives.
• Champion creativity, collaboration, and cross‑functional learning across the organization.

Ideal Qualifications:

• MD or Foreign Equivalent required.
• Minimum of 8 years of experience in clinical drug development. Less experience may be considered for US board Certified Physicians or those with experience working on GI trials.
• Experience in rare disease drug development strongly preferred.
• Gastroenterology experience preferred but not required.
• Academic principal investigator (PI) experience may be considered.