Vice President, Head of Immunology and Inflammation Development

The role

This senior leader will guide late-stage Immunology and Inflammation programs. They will lead cross-functional teams from late-stage clinical development through regulatory submission and approval.

What you will do

• Leads a high performing Product Strategy Team
• Develops high quality development plans aligned with late-stage and corporate objectives
• 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
• Drives development and refinement of Target Product Profiles, 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

Required qualifications

• MD, MD/PhD, or PhD
• 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

• Board certification in Pulmonology, Allergy and Immunology, or Rheumatology
• Previous work in both large pharma and biotech settings
• Respiratory experience in clinical practice, Medical Affairs, Clinical Development or as Project Leader

Benefits

• Annual bonus
• Equity compensation
• Competitive benefits package

About the company

Generate:Biomedicines is a clinical-stage generative biology company pioneering the AI revolution in drug design and development. The company integrates machine learning with large-scale experimentation to design proteins with defined biological intent.