Senior Director, Clinical Operations

Summary

Join Generate:Biomedicines as the Senior Director, Clinical Operations, Late Stage Development, and lead the strategic direction and operational execution of late-stage clinical development. Build and manage a high-performing team, oversee global registrational trials, and manage CRO and vendor partnerships. Ensure trials are optimized for cost-effective, rapid implementation while maintaining the highest standards of scientific and regulatory compliance. Lead vendor governance activities and support the transition from early-stage to late-stage development. Shape the clinical operations strategy, ensuring successful Phase III execution, and positioning Generate for regulatory approvals and commercialization. This is a high-impact role at a pivotal time in Generate:Biomedicines' growth.

Requirements

• 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

Responsibilities

• 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
• 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
• 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
• 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
• 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