Vice President, Head of Immunology and Inflammation Development

About the role

Generate:Biomedicines is seeking an experienced and strategic drug developer and people leader to guide its 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 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.

Responsibilities

• 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 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 studies 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.
• Guides interactions with external stakeholders including KOLs, advisory boards, and CROs.
• Represents Generate externally at scientific, medical, and regulatory meetings.
• Provides medical leadership and awareness of the 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.

Qualifications

• MD, MD/PhD, or PhD required.
• Board certification in Pulmonology, Allergy and Immunology, or Rheumatology preferred but not required.
• 10+ years of drug development experience in the biopharma industry.
• 4+ years of direct people management experience in industry.
• Deep expertise in global late-stage (Phase III) clinical trials.
• Prior experience 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

• Previous work in both large pharma and biotech settings.
• Respiratory experience in clinical practice, Medical Affairs, Clinical Development, or as Project Leader.

Location

Somerville, MA / Andover, MA; remote (U.S.) optional with travel to HQ based on business needs.

About Generate:Biomedicines

We are a clinical-stage generative biology company pioneering the AI revolution in drug design and development. We advance a new approach to drug creation—grounded in the ability to design proteins with defined biological intent—by integrating machine learning with large-scale experimentation. This approach aims to reduce the uncertainty, time, and cost associated with developing protein-based medicines. Founded in 2018, we are advancing a growing pipeline of clinical and preclinical programs across multiple disease areas and protein modalities. By unifying computational design and clinical development within a single operating model, we translate this approach into clinical-stage programs and are leading a shift from traditional drug discovery toward systematic drug generation.