Vice President, Program Leader

Company Confidential – Greater Boston (Hybrid)

Full Time

The Opportunity 

A clinical-stage biotechnology company is seeking an experienced Vice President to serve as Program Leader for its lead therapeutic asset. Reporting to the Chief Medical Officer, this individual will oversee integrated development planning and drive the program through mid and late-stage development, culminating in registration and eventual commercialization. The Program Leader will guide strategic direction, ensure cross-functional alignment, and act as the central driver of program execution.

Key Responsibilities

• Lead strategic and operational planning for the lead asset, including advancement through Phase 2 and preparation for late-stage development.

• Develop integrated development plans that include clinical, regulatory, CMC, preclinical, and commercial considerations to maximize program success.

• Define long term registration strategy and ensure alignment with regulatory expectations, clinical endpoints, and market needs.

• Collaborate with clinical and commercial teams to evaluate indication expansion opportunities and recommend indication prioritization.

• Serve as the primary point of accountability for program execution. Track progress, identify risks early, and implement effective mitigation strategies.

• Partner with regulatory and clinical leadership to prepare for meetings with global health authorities, pivotal trial readiness, and regulatory submissions.

• Ensure program objectives are aligned with corporate strategy, investor expectations, and long range planning.

• Provide high quality program updates, strategic scenarios, and recommendations to executive leadership and the Board.

• Build strong cross functional partnerships across clinical development, regulatory affairs, CMC, commercial, and finance to ensure full organizational readiness for later development stages.

• Foster a culture of accountability, collaboration, and scientific rigor within the program team.

Qualifications

• Advanced degree in a life science discipline (MD, PhD, PharmD, or equivalent) strongly preferred.

• Fifteen or more years of experience in biotech or pharmaceutical development with a proven record of advancing assets through mid and late clinical stages.

• Experience in immunology and inflammation as well as biologics or antibody development preferred.

• Strong understanding of clinical development strategy, regulatory interactions, and product lifecycle planning from early development through registration.

• Direct experience preparing for pivotal trials and leading regulatory submissions with FDA or EMA.

• Ability to think strategically, anticipate challenges, and translate vision into actionable plans.

• Proven success leading cross functional program teams in small or emerging biotech settings.

• Outstanding communication, leadership, and stakeholder management skills.