Vice President, Head of Global Clinical Operations

Generate Biomedicines•Somerville, MA

About The Position

About Generate:Biomedicines Generate:Biomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development. We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us! Generate:Biomedicines was founded in 2018 by Flagship Pioneering and has received nearly $700 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees. 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 lea der will ensure that trials are optimized for cost - effective, rapid implementation while maintaining the highest standards of scientific and regulatory compliance. They wil l 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 l ate - 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/vend or partnerships in alignment with our evolving pipeline.

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 experience leading the development and implementation of trial execution strategy and long - range plans ensuring trials are conducted on time, efficiently and cost - effectively.
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

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 executi on. 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