Global Product Manager – Industrial Separation and Wastewater
Xylem
Senior Director, Clinical Development – Asthma
Generate Biomedicines
full-time
Posted on:
Origin: • 🇺🇸 United States • Massachusetts
Visit company websiteSalary
💰 $254,000 - $381,000 per year
Job Level
Senior
About the role
- Lead the Clinical Development Team (CDT) to deliver Phase 3 asthma studies
- Provide medical leadership and oversight for late-stage clinical trials in asthma
- Develop and refine clinical strategies and Target Product Profiles (TPPs) specific to asthma
- 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)
- Manage oversight committees for late-stage asthma studies (e.g., DSMB, Endpoint Adjudication Committee)
- 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
- Hold teams to high standards for technical and collaborative performance
- Foster a high-performing, diverse, and inclusive team culture
- Promote enterprise thinking and strategic alignment across functions
- Communicate with clarity, courage, and empathy
- Model resilience, adaptability, and informed risk-taking
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
- Additional scientific training (e.g., fellowship, MPH) a plus
