Vice President Clinical Development

Our client is a commercial-stage biopharmaceutical company focused on advancing novel therapies for serious metabolic and liver diseases with significant unmet need. The organization is at an important inflection point, building from a successful approved therapy into a broader, mechanism-driven pipeline that spans lifecycle expansion, late-stage development, and new assets entering early clinical development. This is an opportunity to join a growing, scientifically driven company with the urgency of a biotech, the complexity of a global development organization, and the ambition to shape the future of care in a major chronic disease area.

About the role

The Vice President, Clinical Development Program Leader will serve as a senior clinical leader responsible for shaping, leading, and executing clinical strategy across one or more therapeutic programs. This role combines strategic program leadership, cross-functional oversight, and hands-on clinical development execution from early development through registration and lifecycle management. The VP will partner closely with executive leadership, Translational Medicine, Nonclinical, Regulatory, Clinical Operations, Biometrics, Safety, CMC, Commercial, and external experts to drive integrated development plans, ensure patient safety, and advance high-quality clinical programs aligned with corporate priorities.

Responsibilities

• Lead cross-functional program teams and drive integrated clinical development strategy across assigned assets.
• Shape product strategy, clinical hypotheses, Target Product Profiles, indication prioritization, and development plans.
• Lead Clinical Development Plans from first-in-human and proof-of-concept through late-stage and registration-enabling studies.
• Oversee design and medical governance of Phase I–IV clinical trials, including FIH, SAD/MAD, translational, PoC, registrational, and lifecycle studies.
• Provide senior medical oversight, ensuring patient safety, data integrity, benefit-risk assessment, and timely clinical decision-making.
• Lead or support regulatory interactions with global health authorities, including pre-IND, Scientific Advice, End-of-Phase, and submission-related meetings.
• Oversee medical and strategic content for INDs, amendments, Investigator Brochures, briefing books, clinical study reports, and marketing application components.
• Integrate clinical development, translational medicine, biostatistics, operations, safety, regulatory, CMC, commercial, and market access perspectives into cohesive program strategy.
• Partner with Translational Medicine and Nonclinical teams to shape biomarker strategy, assay readiness, patient stratification, and mechanism-based differentiation.
• Build strong relationships with KOLs, investigators, scientific advisors, and development partners.
• Represent the company externally at scientific meetings, advisory boards, and collaborative forums.
• Mentor clinical scientists, medical directors, and cross-functional colleagues while contributing to scalable development processes and best practices.
• Foster a culture of scientific rigor, accountability, openness, and ethical decision-making.

Requirements

• MD or DO required; board certification in Internal Medicine, Gastroenterology, Hepatology, Endocrinology, or a related specialty preferred.
• 10–15+ years of clinical development experience, with significant leadership across early- and late-stage programs.
• Proven success leading clinical programs across the development lifecycle, including INDs, regulatory filings, late-stage development, launch, and commercialization support.
• Experience leading or contributing to global regulatory interactions with FDA, EMA, PMDA, or other health authorities.
• Strong understanding of clinical development strategy, translational science, regulatory expectations, CMC considerations, and commercial context.
• Experience in liver disease, MASH/NASH, metabolic disease, cardiometabolic disease, inflammation, endocrine pathways, or adjacent therapeutic areas is highly relevant.
• Demonstrated ability to lead in global, matrixed environments and influence across functions without direct authority.
• Strong clinical judgment, scientific rigor, communication skills, and executive presence.
• Ability to create strategy from incomplete data and make disciplined benefit-risk decisions in a fast-moving environment.

Ideal candidate

The ideal candidate is a physician executive who can operate at both the strategic and practical levels: setting direction, challenging assumptions, aligning stakeholders, and staying close enough to the science and clinical data to guide high-quality development decisions. This person will thrive in a growing biotech environment where accountability is high, ambiguity is real, and strong leadership requires both scientific depth and cross-functional influence.

Location: Greater Philadelphia Area