Vice President, Immunology and Inflammation 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

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

Requirements

• 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

Core Competencies

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.

Highest-signal resume keywords

• 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

ATS Optimization Keywords

Hard 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

Soft Skills

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

Certifications & Qualifications

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

Industry Keywords

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