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 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 (Optional):

• 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.

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 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.

At Generate:Biomedicines, we collaborate across disciplines in new ways to invent and innovate. We bring diverse perspectives to a shared goal of delivering better medicines to patients in need, faster, guided by our values and leadership behaviors.

Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.

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