Vice President, Clinical Operations

Summary

Join Generate:Biomedicines as their Vice President of Clinical Operations and lead the strategic direction and execution of clinical trials. You will build and scale the Clinical Operations function across all phases of development, focusing on Phase I and II patient-based studies and overseeing Phase III studies. This role demands innovation beyond traditional clinical trial paradigms, optimizing for cost-effectiveness and rapid implementation while maintaining high scientific and regulatory compliance. You will lead vendor governance, manage the transition from early- to late-stage development, and work with unconventional study designs. The ideal candidate will have extensive experience in clinical operations within biotech/pharmaceutical companies, including leadership roles and experience in rare diseases and/or oncology.

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
• 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

Responsibilities

• Own the strategy and delivery of clinical operations across early- and mid-stage trials, ensuring excellence in execution for Phase I through Phase III, including studies in healthy volunteers as well as patient-based studies
• Develop and implement trial strategies that support rapid, cost-efficient execution, including unconventional or accelerated pathways for novel therapeutics
• Partner cross-functionally with Clinical Development, Regulatory, Biometrics, Medical Affairs, Program Management, and others to develop and deliver integrated clinical development plans
• Lead all aspects of clinical trial execution: protocol development, site and vendor selection, study planning, conduct, data delivery, and close-out
• Develop, manage, and track study-level and program-level timelines, budgets, KPIs, and risk mitigation strategies
• Provide senior oversight of CROs, vendors, and investigator sites to ensure study quality, compliance, and performance metrics are met or exceeded
• Lead and grow a high-performing Clinical Operations team with line management responsibility, including performance management and career development
• Mentor internal team members while optimizing a hybrid model of internal and external resources to support shifting priorities and pipeline evolution
• Drive cross-functional collaboration and organizational alignment to maintain operational efficiency and accountability
• Design and deliver studies in challenging therapeutic areas, including rare disease and oncology, where trial populations are limited or difficult to enroll
• Champion fit-for-purpose operational models that include direct-to-patient models, adaptive designs, or patient-first early-phase strategies
• Anticipate challenges in study conduct and lead creative solutions to optimize enrollment and retention in difficult populations
• Ensure trials are conducted in compliance with ICH-GCP, FDA, EMA, and other global regulatory standards
• Support global inspection readiness and contribute to regulatory filings (e.g., IND, NDA, BLA, MAA)
• Implement and evolve SOPs, work instructions, and operational policies in line with industry best practices

Preferred Qualifications

• Experience with rare diseases and/or oncology strongly preferred
• Demonstrated ability to execute innovative or nontraditional study designs, including those targeting challenging-to-recruit populations. Prior experience leading the development and implementation of trial execution strategy and long-range plans ensuring trials are conducted on time, efficiently and cost-effectively