Vice President, Immunology and Inflammation Development

Lead a high-performing Product Strategy Team responsible for late-stage immunology and inflammation program strategy
Develop ambitious, high-quality development plans aligned with late-stage and corporate objectives and relevant regulations
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 programs through registration development and BLA readiness to support global regulatory submissions
Drive refinement of Target Product Profiles, Target Product Claims, and clinical development strategies
Guide interactions with KOLs, advisory boards, and CROs
Represent Generate externally at scientific, medical, and regulatory meetings
Provide medical leadership and monitor the evolving external landscape for late-stage respiratory-disease clinical trials
Build an inclusive, high-performing team culture and promote cross-functional alignment

• MD, MD/PhD, or PhD required
• 10+ years of drug development experience in the biopharma industry
• 4+ years of 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 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
• Board certification in Pulmonology, Allergy and Immunology, or Rheumatology preferred but not required
• Previous work in both large pharma and biotech settings optional
• Respiratory experience in clinical practice, Medical Affairs, Clinical Development, or as Project Leader optional

Demonstrates extensive expertise in late-stage clinical development, particularly in leading cross-functional teams through pivotal studies and regulatory submissions. Proven ability to mentor and develop high-performing teams while effectively collaborating with stakeholders in the biopharma industry.

• MD, MD/PhD, Or PhD
• 10+ Years Of Drug Development Experience
• Deep Expertise In Global Late-Stage Clinical Trials
• Leadership In BLA/NDA Submission
• Strong Analytical And Communication Skills

• Clinical Development Strategy
• Risk-Benefit Profile Definition
• Target Product Profile Refinement
• Regulatory Submission Preparation
• Pivotal Study Leadership
• Cross-Functional Team Leadership
• Pharmacovigilance Collaboration
• KOL Engagement
• Budget Management
• Study Delivery

• Mentoring
• Influencing Stakeholders
• Team Building
• Cross-Functional Alignment
• Communication

• Board Certification In Pulmonology
• Board Certification In Allergy And Immunology
• Board Certification In Rheumatology

• Biopharma
• Late-Stage Immunology
• Inflammation Program Strategy
• Clinical Operations
• CRO Collaboration
• Medical Affairs
• Respiratory-Disease Clinical Trials
• Global Regulatory Submissions
• Advisory Boards
• Investors