Director, Study LeadLocation: Hybrid - Boston, MA or San Diego, CA
Employment Type: Full-time
Reports to: SVP, Clinical Development Operations
About the RoleThe
Director, Study Lead is accountable for end-to-end operational leadership of a global Phase II clinical study, ensuring delivery on time, within budget, and with high quality. This role is ideal for a seasoned clinical operations leader who thrives in fast-paced biotech environments, excels at strategic decision-making, and can translate program goals into operational reality. The Study Lead will partner closely with Clinical Development, Medical Affairs, Regulatory, Biometrics, Safety, and external CROs/vendors to ensure seamless execution across regions.
Key ResponsibilitiesStudy Strategy & Planning- Lead development of the global study operational strategy, timelines, enrollment plan, and risk mitigation approach.
- Drive country and site selection strategy using data-driven feasibility, historical performance, and patient population insights.
- Partner with Clinical Development to ensure protocol design is operationally feasible and aligned with scientific objectives.
Study Execution & Oversight- Serve as the primary operational leader for the Phase II study, accountable for delivery of key milestones (FPI, enrollment targets, database locks, CSR).
- Oversee CRO performance, ensuring proactive issue resolution, quality oversight, and adherence to KPIs.
- Lead global study team meetings, ensuring clear decision-making, action tracking, and cross-functional alignment.
- Monitor enrollment trends, site performance, and operational risks; implement corrective actions as needed.
Vendor & Site Management- Oversee all study vendors (CRO, central labs, imaging, eCOA, IRT, safety vendors, etc.) including selection, contracting input, and ongoing oversight.
- Ensure site engagement strategies are implemented globally, partnering with Site Engagement, Patient Recruitment, and Medical Affairs teams.
- Support inspection readiness activities and ensure TMF completeness and quality.
Data, Quality & Compliance- Partner with Biometrics and Data Management on data review plans, query management, and interim analysis readiness.
- Ensure adherence to ICH-GCP, regulatory requirements, and internal SOPs across all regions.
- Lead risk management and quality oversight, including issue escalation, CAPA development, and audit support.
Cross-Functional Leadership- Collaborate closely with Clinical Development, Regulatory, Safety, CMC, and Program Management to ensure integrated planning and execution.
- Provide operational input into key program deliverables including IB updates, regulatory submissions, and safety reviews.
- Communicate study status, risks, and decisions to senior leadership and governance bodies.
Budget & Resource Management- Develop and manage the study budget, including vendor costs, site payments, and contingency planning.
- Forecast resource needs and ensure appropriate staffing across internal and external teams.
Qualifications- Bachelor's degree in life sciences or related field; advanced degree preferred.
- 10+ years of clinical operations experience in biotech/pharma, with 5+ years leading global Phase II/III studies.
- Proven experience overseeing CROs and complex vendor ecosystems.
- Strong understanding of global regulatory requirements, ICH-GCP, and operational best practices.
- Demonstrated ability to lead cross-functional teams and drive decision-making in ambiguous, fast-moving environments.
- Excellent communication, leadership, and problem-solving skills.
- Experience in IBD preferred but not required.
- Prior small-to-mid-size biotech experience strongly preferred.
