Head of Clinical Operations

Head of Clinical Operations

This role is open to candidates at Senior Director or Executive Director level.

Location: Boston MA / and neighbouring states (required to be in the office once every few weeks)

About the Company

A dynamic and innovative pharmaceutical company, specializing in oncology-focused therapeutics, is seeking an accomplished leader to join its team. This organization is dedicated to advancing precision medicine and developing ground-breaking treatments for cancer patients around the world. With a diverse pipeline that includes cutting-edge therapies, the company is addressing some of the most pressing challenges in oncology today.

The Role

We are seeking an experienced Head of Clinical Operations to take charge of the clinical operations team and drive excellence across global early- and late-phase oncology trials. Reporting directly to the Chief Medical Officer, this role is critical to the company’s success in delivering high-quality clinical programs that meet regulatory requirements and advance its innovative oncology pipeline.

Main Responsibilities

• Strategic Leadership: Define and oversee the strategic direction for clinical trials across the oncology portfolio. Ensure efficient planning and delivery of trials, including meeting recruitment targets, timelines, and budgets.
• Vendor and Budget Oversight: Build and maintain strong relationships with CROs, ensuring cost-effective and high-quality study execution. Lead contract negotiations and oversee operational deliverables.
• Regulatory Submissions: Manage clinical operations for regulatory filings, including INDs, NDAs, and BLAs. Prepare the team for regulatory inspections from agencies such as the FDA and EMA.
• Team Leadership: Lead, mentor, and develop a high-performing clinical operations team. Foster a collaborative and results-driven culture to support complex oncology trials.
• Operational Execution: Streamline trial design, feasibility, and execution processes. Drive cross-functional collaboration with Clinical Development, Regulatory Affairs, and Medical Affairs to achieve clinical program goals.

Requirements

• Education: Advanced degree (PhD preferred) in life sciences or a related field.
• Experience: At least 10 years of experience in clinical operations, with a focus on oncology. A proven track record in managing both early- and late-phase trials and navigating regulatory submissions is essential.
• Skills: Exceptional abilities in CRO management, contract negotiation, strategic planning, and problem-solving.
• Languages: Fluency in English is required