Generate Biomedicines

Pioneering generative biology to create breakthrough therapeutics.

Senior Director, Clinical Development – Medical Lead, Asthma and COPD

Full TimeRemoteTeam 201-500Since 2020H1B SponsorCompany SiteLinkedIn

Location

Massachusetts

Posted

16 days ago

Salary

$277K - $416K / year

Postgraduate Degree8 yrs expEnglish

Job Description

• Medical Lead for the Clinical Development Team (CDT) to deliver Phase 3 asthma and COPD studies • Provide medical leadership and oversight for late-stage clinical trials in asthma and COPD • Develop and refine clinical strategies and Target Product Profiles (TPPs) specific to asthma and COPD • Serve as key author of late-stage clinical protocols, aligned with regulatory requirements • Author clinical and scientific content for regulatory submissions (e.g., BLA, MAA) • Oversee study design, protocol development, data review, and safety monitoring • Perform medical monitoring for late-stage studies, ensuring patient safety, protocol compliance, and data integrity • Serve as a member of the Safety Management Team (SMT) • Collaborate cross-functionally with Clinical Operations, Regulatory, Biostatistics, and Pharmacovigilance • Serve as primary medical contact for clinical sites, investigators, and CROs • Interpret clinical trial data and contribute to study reports, regulatory filings, and publications • Represent Generate at internal and external scientific and medical meetings • Engage with external experts, advisory boards, and health authorities to support program goals

Job Requirements

  • MD (required); board certification in Pulmonology or Allergy & Immunology preferred
  • 8+ years of clinical development experience in the biopharma industry
  • Extensive expertise in asthma and respiratory clinical trial design
  • Experience leading late-stage trials and engaging with regulatory bodies
  • Strong cross-functional leadership and communication skills
  • Proven ability to collaborate with internal teams and external stakeholders.

Benefits

  • Annual bonus
  • Equity compensation
  • Competitive benefits package

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