Vice President, Head of Immunology and Inflammation Development

American Society of Gene & Cell Therapy; Somerville (MA); Hybrid; USD 335,000 - 435,000; Full time

Job summary

Generate:Biomedicines seeks an experienced MD/PhD-level leader to guide late-stage Immunology and Inflammation programs. The VP will shape development strategies, lead cross-functional teams, and ensure robust safety oversight and data integrity for global regulatory submissions.

The role requires building and mentoring a high-performing team of physicians and scientists, influencing stakeholders, and aligning with corporate objectives across Clinical Operations, Safety, Regulatory, and

Qualifications

• MD/PhD or PhD required and board certification preferred but not required.
• 10+ years of drug development experience in biopharma.
• 4+ years of direct people management experience.
• Deep expertise in global late-stage (Phase III) clinical trials.
• Experience leading pivotal development and regulatory submissions (BLA/NDA).
• Proven ability to influence internal/external stakeholders and health authorities.

Responsibilities

• Lead a cross-functional team of clinicians and scientists.
• Develop and guide late-stage development strategies aligned with corporate goals.
• Oversee study design, timelines, and budgets for late-stage programs.
• Collaborate with Safety, Regulatory, Biometrics, Translational Sciences, and CRO partners.
• Drive Target Product Profiles and clinical development strategies.
• Represent the company at scientific, medical, and regulatory meetings.

Skills

Leadership

Cross-functional leadership

Late-stage development

Regulatory strategy

Stakeholder influence

Education

MD/PhD/PhD required

Board certification preferred

Job description

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 withtravel 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.

Compensation: The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.

Per Year Salary Range $335,000—$435,000 USD