Senior Director, Clinical Operations (Late Stage Development)

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 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 Senior Director, Clinical Operations, Late Stage Development is responsible for the strategic leadership and operational execution of late-stage clinical development at Generate:Biomedicines. This individual will build and lead a high-performing team, manage global registrational trials, oversee CRO and vendor partnerships, and drive inspection readiness and regulatory submissions.

Reporting to and working closely with the Vice President, Clinical Operations, the Senior Director, Clinical Operations, Late Stage Development directs global clinical operational activities for Generate:Biomedicines. Concurrently, the incumbent will also directly supervise a clinical operations staff and all activities related to executing clinical studies and full development programs in accordance with company SOPs, FDA, & ICH guidelines and regulations. In this role, the Senior Director 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, ensuring Generate is equipped to independently execute global Phase II/III trials in the future.

Here's how you will contribute:

Strategic Leadership & Clinical Trial Execution

· Lead the late-stage clinical operations strategy, ensuring alignment with regulatory, commercial, and corporate milestones.

· Oversee the planning, execution, and delivery of Phase II and Phase III trials, including global registrational studies.

· Ensure clinical programs are designed for efficiency, quality, and compliance, integrating best practices in trial management.

· Partner with cross-functional teams, including Clinical Development, Biometrics, Regulatory, and Technical Operations, to deliver high-quality Clinical Development Plans.

· Establish and manage operational budgets and timelines for all late-stage clinical studies.

CRO, Vendor, & Site Oversight

· Lead selection, negotiation, and oversight of Contract Research Organizations (CROs), functional service providers, and other key vendors to align with late-stage development needs.

· Oversee the qualification, onboarding, and performance management of clinical trial sites globally.

· Develop and implement vendor governance strategies to drive operational excellence.

· Ensure global inspection readiness and regulatory compliance across all late-stage studies.

Team Leadership & Organizational Growth

· Supervise staff associated with clinical operations as well as CROs and vendors associated with operational functions

· Build, mentor, and scale a Clinical Operations team with late-stage expertise, equipping Generate to bring trials in-house over time.

· Develop and implement operational tools to track and evaluate key performance indicators (KPIs), risk mitigation plans, and program milestones.

· Champion cross-functional collaboration to ensure alignment between Clinical Operations and other drug development functions.

Regulatory & Quality Compliance

· Ensure adherence to GCP, and other ICH guidelines, and regional regulatory guidelines (FDA, EMA, etc.) for late-stage development.

· Lead data review and discrepancy resolution, team meetings/presentations with senior management, in the US, EU and Japan, as needed

· Partner with GxP Quality to lead global inspection readiness efforts for clinical study teams.

· Provide operational input into regulatory filings (NDA/BLA/MAA) and advisory meetings.

Innovation & Process Optimization

· Evaluate and implement emerging technologies that enable our machine learning platform to enhance clinical trial execution.

· Lead the development of Standard Operating Procedures (SOPs), work instructions, and clinical operations policies in alignment with regulatory requirements.

The Ideal Candidate will have:

· Bachelor’s degree required; advanced degree preferred.

· 10 years of experience in clinical operations/drug development, including 8+ years in a pharma/biotech setting.

· Deep expertise in late-stage (Phase II/III) clinical development, including global registrational trials.

· Proven experience leading cross-functional teams and managing clinical operations for pivotal studies.

· Expertise in CRO and clinical vendor selection, governance, and contract negotiations.

· Strong knowledge of GCP and other, ICH guidelines, and global regulatory requirements (FDA, EMA, etc.).

· Demonstrated ability to lead, mentor, and develop high-performing teams.

· Strategic mindset with strong problem-solving and risk mitigation skills.

· Ability to travel up to 20% domestically and internationally.

Who Will Love This Job: 

This is a high-impact role at a pivotal time in Generate:Biomedicines' growth. As we expand into late-stage drug development, you will play a critical leadership role in shaping our clinical operations strategy, ensuring successful Phase III execution, and positioning Generate for regulatory approvals and commercialization.

Join us in transforming drug development through AI and bringing first-in-class therapies to patients!

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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