Vice President, Head of Immunology and Inflammation Development
full-time
lead
Posted 1 day ago
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About this role
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 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 / Andover, MA; remote (U.S.) optional with travel to HQ based on business needs.
Why Join Us
This is a rare opportunity to shape the future of immunology and inflammation medicine at a company pioneering Generative Biology™. You’ll be empowered to lead transformative trials in a collaborative, mission-driven environment, surrounded by relentless problem solvers who are reimagining what’s possible in drug discovery and development. You’ll have the scope, visibility, and autonomy to influence both the success of the portfolio and the capabilities of the organization, working alongside ambitious, collaborative leaders who are reimagining how medicines are discovered and developed for patients with significant unmet needs.
About Generate:Biomedicines
We are a clinical-stage generative biology company pioneering the AI revolution in drug design and development. We are advancing a new approach to drug creation—one grounded in the ability to design proteins with defined biological intent. By integratin
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