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

Confirmed live in the last 24 hours

Generate Biomedicines

Remote

Hybrid

Posted April 9, 2026

Job Description

* 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.

Reporting 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 perfor

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