Generate Biomedicines
Pioneering generative biology to create breakthrough therapeutics.
Vice President, Global Clinical Operations
Location
United States
Posted
1 day ago
Salary
$281K - $422K / year
Bachelor Degree15 yrs expEnglish
Job Description
• Responsible for the strategic leadership and operational execution of clinical trials at Generate:Biomedicines.
• Lead the execution and evolution of global clinical development programs.
• Reporting to the Chief Medical Officer (CMO).
• Build and scale the Clinical Operations function across all phases of development.
• Ensure trials are optimized for cost-effective, rapid implementation while maintaining the highest standards of scientific and regulatory compliance.
• Lead vendor governance activities and support the transition from early-stage to late-stage development.
• Deliver high-quality clinical trials in complex patient populations and demonstrate experience leading clinical operations for respiratory/pulmonary indications.
Job Requirements
- Bachelor’s degree in life sciences, nursing, or related field (advanced degree preferred).
- 15+ years of experience in clinical operations within biotech/pharmaceutical companies with 8+ years in direct people leadership roles.
- Proven success leading Phase I, II and III clinical trials, including early stage studies in patients rather than healthy volunteers.
- Respiratory/pulmonary clinical trial operations experience is required, including demonstrated leadership of Phase III global studies (or registrational-stage programs) in respiratory indications.
- Demonstrated ability to execute innovative or nontraditional study designs, including those targeting challenging-to-recruit populations.
- Prior management experience, including leadership of internal clinical staff and performance oversight of external contractors and vendors.
- Expertise in vendor governance, CRO management, and building agile clinical operations teams that flex with pipeline needs.
- Experience supporting regulatory filings (e.g. INDs, BLAs, MAAs, etc.) and interacting with regulatory agencies, including FDA and EMA.
- Strategic thinker with excellent organizational, problem-solving, and communication skills.
- Excellent interpersonal skills with ability to lead, influence, resolve conflict, and drive consensus among people at various levels within the organization and from a variety of functions.
Benefits
- annual bonus
- equity compensation
- competitive benefits package
