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.

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.

Vice President, Global Clinical Operations

Key skills