About the role
Director, Study Lead
Location: Hybrid – Boston, MA or San Diego, CA
Employment Type: Full‑time
Reports to: SVP, Clinical Development Operations
About the Role
The 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 Responsibilities
Study 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.