Director / Senior Director - Clinical Operations

Director / Senior Director - Clinical Operations

Location: Hybrid – Boston, MA 

Employment Type: Full‑time

Reports to: SVP, Clinical Development Operations

About the Role

The Director / Senior Director, Clinical Operations 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 Director / Senior Director, Clinical Operations 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.