Vice President, Head of Immunology and Inflammation Development

The Role:

Generate:Biomedicines is seeking an experienced and strategic drug developer and people leader to guide our late-stage Immunology and Inflammation (I&I) programs. Reporting directly to the Chief Medical Officer I&I, this senior business leader will shape integrated development strategies and lead cross-functional teams from late-stage clinical development through regulatory submission and approval.  

The successful VP, Head of I&I Development candidate will recruit, build, and develop a high-performing team of physicians and scientists, creating clear accountability while enabling strong collaboration across Clinical Operations, Safety, Regulatory, Biometrics, Translational Sciences, and other key functions. They will be accountable for the design and delivery of rigorous late-phase development programs, ensuring scientific and clinical excellence, robust safety oversight, data integrity, and alignment with the company’s broader strategy.  

The ideal candidate is an MD, MD/PhD, or PhD with significant biopharmaceutical industry experience in immunology and a demonstrated track record of strategic drug development, executional excellence in pivotal trials, and building and leading high-performing teams.  

Here's how you will contribute:

Leads a high performing Product Strategy Team (PST) comprised of cross-functional leaders accountable for setting the strategy for the late stage I&I programs

Develops high quality, ambitious development plans for aligned with late-stage and corporate objectives and compliant with all relevant regulations

Recruits, mentors and develops a team of late-stage clinicians and scientists

Collaborates with Head of Safety and PV to define risk-benefit profiles

Collaborates with Clinical Operations and CRO to deliver study to timelines and budget

Leads programs through registration development and BLA readiness, ensuring clinical strategy, evidence generation, and execution support successful global regulatory submissions.

Drives development and refinement of Target Product Profiles (TPPs), Target Product Claims, and clinical development strategies

Guide interactions with external stakeholders including KOLs, advisory boards, and CROs

Represent Generate externally at scientific, medical, and regulatory meetings

Provides medical leadership and awareness of evolving external landscape for late-stage clinical trials in respiratory diseases  

Leadership Responsibilities

Lead, develop, and mentor a high-performing team of physicians and clinical scientists.  

Hold teams to high standards for technical and collaborative performance

Build and develop a diverse, high-performing, and inclusive team culture

Promote enterprise thinking and cross-functional alignment with strategic goals

Communicate with clarity, courage, and empathy across all levels of the organization

Foster resilience, adaptability, and informed risk-taking in pursuit of innovation

The Ideal Candidate will have:

MD, MD/PhD, or PhD is required. Board certification in Pulmonology, Allergy and Immunology, or Rheumatology is preferred but not required.

10+ years of drug development experience in the biopharma industry

4+ years direct people management experience in industry

Deep expertise in global late-stage (Phase III) clinical trials

Prior ex perience leading a cross-functional clinical development team through pivotal development and successful BLA/NDA submission    

Demonstrated success in leading pivotal global studies and regulatory interactions

Strong analytical, communication, and cross-functional leadership skills

Proven ability to influence internal and external stakeholders, including investors, investigators, and health authorities

Nice to Have (Optional):

Previous work in both large pharma and biotech settings

Respiratory experience in clinical practice, Medical Affairs, Clinical Development or as Proje ct Leader  

Location: Somerville, MA / Andov …