Global VP Immunology & Inflammation Clinical Development

Jobtailor; Somerville (MA); On-site; USD 250,000 - 350,000; Full time

Job summary

Generate seeks a senior leader to head the Product Strategy Team for late-stage immunology and inflammation programs. You will craft ambitious development plans aligned with regulatory goals and corporate objectives, and recruit and mentor a high-performing team of clinicians and scientists.

You will define risk-benefit profiles with Safety and Pharmacovigilance leadership, collaborate with Clinical Operations and CROs to deliver studies on time and within budget, and drive global submissions

Qualifications

• MD/PhD or PhD 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 global studies and regulatory interactions.
• Board certification in Pulmonology, Allergy & Immunology, or Rheumatology preferred.

Responsibilities

• Lead late-stage clinical development and cross-functional teams through pivotal trials.
• Develop ambitious development plans aligned with regulatory goals and corporate objectives.
• Recruit, mentor, and develop late-stage clinicians and scientists.
• Define risk-benefit profiles with Safety and Pharmacovigilance leadership.
• Collaborate with Clinical Operations and CROs to deliver studies on time and within budget.
• Lead regulatory submissions (BLA/NDA) and global registrations.
• Interact with KOLs, advisory boards, and health authorities.
• Represent Generate at scientific, medical, and regulatory meetings.

Skills

Clinical strategy

Risk-benefit definition

TPP refinement

Regulatory submissions

Pivotal study leadership

Cross-functional leadership

Pharmacovigilance collaboration

KOL engagement

Budget mgmt

Study delivery

Education

MD, MD/PhD, or PhD

Job description

Generate seeks a senior leader to head the Product Strategy Team for late-stage immunology and inflammation programs. You will craft ambitious development plans aligned with regulatory goals and corporate objectives, and recruit and mentor a high-performing team of clinicians and scientists.

You will define risk-benefit profiles with Safety and Pharmacovigilance leadership, collaborate with Clinical Operations and CROs to deliver studies on time and within budget, and drive global submissions