Vice President, Head of Global Clinical Operations (Late Stage Respiratory/Pulmonary focus)

* A cover letter outlining your late stage global experience in Respiratory/Pulmonary clinical trials would be appreciated* The Role: The Vice President, Head of Global Clinical Operations is responsible for the strategic leadership and operational execution of clinical trials at Generate:Biomedicines; this role will lead the execution and evolution of our global clinical development programs.  R eporting to the Chief Medical Officer (CMO), this leader will be responsible for building and scaling the Clinical Operations function across all phases of development, with a strong emphasis on leading and delivering global Phase III programs and ensuring registrational readiness. The successful leader will ensure that trials are optimized for cost-effective, rapid implementation while maintaining the highest standards of scientific and regulatory compliance. They will also lead vendor governance activities and support the transition from early-stage to late-stage development. This role requires someone comfortable operating in a fast-moving environment and delivering high-quality clinical trials in complex patient populations. Demonstrated experience leading clinical operations for respiratory/pulmonary indications (including late-stage/Phase III execution) is required, along with experience across all stages of development. The successful candidate will be a hands-on people leader who can direct internal staff, manage a dynamic contractor ecosystem, and forge strategic CRO/vendor partnerships in alignment with our evolving pipeline. Here's how you will contribute: Strategic Clinical Leadership • Own the strategy and delivery of clinical operations across trials, ensuring excellence in execution for Phase I through Phase III, including studies in healthy volunteers as well as patient-based studies, with a strong emphasis on global Phase III execution.   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. Clinical Trial Execution & Oversight • 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. Team Building & Management • 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. Innovation & Adaptability • Design and deliver studies in respiratory/pulmonary indications, navigating operational complexity such as global enrollment/retention, site performance, and (as applicable) pulmonary assessments and endpoint execution. • Champion fit-for-purpose operational models that incorporate direct-to-patient approaches, adaptive designs, patient-first early-phase strategies, and AI-driven methodologies to optimize trial efficiency and execution. • Anticipate challenges in study conduct and lead creative solutions to optimize enrollment and retention. Regulatory, Compliance, and Quality • 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. The Ideal Candidate will have: 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 experience leading the development and implementation of trial execution strategy and long-range plans ensuring trials a