What are the responsibilities and job description for the Head of Clinical Operations position at Scienta?
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
How to Apply
If you’re a strategic thinker and operational expert with a passion for advancing oncology therapeutics, we want to hear from you. Please submit your CV here. Feel free to include a cover letter detailing your relevant experience and achievements.
