Senior VP, Immunology & 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

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