Job description
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 over $700 millionin 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 of 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 SVP of Clinical Drug Development, this leader will be responsible for building and scaling the Clinical Operations function across all phases of development, with a strong focus on Phase I and II patient-based studies, as well as oversight of Phase III studies, applying a demonstrated ability to innovate beyond traditional clinical trial paradigms. 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 with unconventional study designs—including those that initiate directly in patient populations and target hard-to-reach or difficult-to-treat indications. Experience in oncology and/or rare diseases is desirable, and experience across all stages of development is required. The successful candidate will be a hands-on 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 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.
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 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.
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.
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
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
Why Join Generate?
This role offers a unique opportunity to build a world-class clinical operations function in a science-driven organization focused on cutting-edge therapies. You will play a pivotal role in bringing transformative treatments to patients, often in areas underserved by conventional drug development approaches.
Join us to challenge the norms of clinical development and lead a team that is bold, adaptable, and deeply committed to patient-centered innovation.
Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
COVID Safety:
Generate:Biomedicines enforces a mandatory vaccination policy for COVID-19. All employees must be fully vaccinated and have received a booster. The purpose of this policy is to safeguard the health of our employees, their families, and the community at large from infectious disease that may be reduced by vaccinations. The Company will make exceptions to this policy if required by applicable law and will consider requests for an exemption from this policy due to a medical reason, or because of a sincerely held religious belief, or any other exemptions that may be recognized by applicable.
Recruitment & Staffing Agencies : Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.
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