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Generate:Biomedicines

Vice President, Head of Immunology and Inflammation Development

RemoteUnited States only
Published
Role
Fullstack
Experience
C-Level
Employment
Full-time
$335k–$435k/yr
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Open to US only. Set where you work from to check your eligibility.

No BS summary

Generate:Biomedicines is seeking an experienced and strategic drug developer and people leader to guide our late-stage Immunology and Inflammation (I&I) programs.

Core skills

ImmunologyInflammationClinical development

Required skills

MD/MD/PhD/PhDBoard certification in Pulmonology/Board certification in Allergy and Immunology/Board certification in RheumatologyDrug development/People management/Phase III clinical trials/BLA/NDA submission/Regulatory interactionsAnalytical skillsCommunication skillsCross-functional leadershipInfluence stakeholders

Optional skills

Previous work in both large pharma and biotech settingsRespiratory experience in clinical practice, Medical Affairs, Clinical Development or as Project Leader

Required languages

English unknown

What you'll do

  • Leads a high performing Product Strategy Team (PST) comprised of cross-functional leaders accountable for setting the strategy for the late stage I&I programs
  • Develops high quality, ambitious development plans for aligned with late-stage and corporate objectives and compliant with all relevant regulations
  • 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, ensuring clinical strategy, evidence generation, and execution support successful global regulatory submissions.
  • Drives development and refinement of Target Product Profiles (TPPs), 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

What they require

  • MD, MD/PhD, or PhD is required. Board certification in Pulmonology, Allergy and Immunology, or Rheumatology is preferred but not required.
  • 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

Benefits

  • annual bonus
  • equity compensation
  • competitive benefits package

Generate:Biomedicines is a clinical-stage generative biology company pioneering the AI revolution in drug design and development, using machine learning and large-scale experimentation to design protein-based medicines.

BiotechStartup
$335k–$435k/yr