Generate Biomedicines

Pioneering generative biology to create breakthrough therapeutics.

Vice President, Global Clinical Operations

Clinical OperationsClinical OperationsFull TimeRemoteTeam 201-500Since 2020H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

7 days 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

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