Director of Clinical Operations (Boston, MA)

Director of Clinical Operations (Boston, MA)

Summary:

The Director of Clinical Operations oversees all aspects of clinical operations for a priority immunology program, driving multiple studies across phases I-III. This leadership role requires expertise in clinical operations, strategic planning, and team management. The Director collaborates with cross-functional teams and external partners to ensure that trials are conducted on time, within budget, and to high-quality standards.

• Lead the strategic planning, implementation, and execution of clinical trials for a key immunology program, ensuring adherence to project timelines, budgets, and quality standards.
• Develop and manage comprehensive program project plans, including protocols, trial budgets, timelines, enrollment strategies, and risk mitigation approaches.
• Collaborate with internal teams—Clinical Development, Regulatory Affairs, Biostatistics, Translational Medicine, and Program Leadership—to align on clinical objectives and milestones.
• Provide strategic input for Clinical Development Plans (CDP) to support the overall program strategy.
• Serve as the primary liaison for CROs and vendors, overseeing performance and ensuring adherence to contractual agreements and quality standards.
• Ensure compliance with regulatory requirements, ICH-GCP standards, and company SOPs throughout all trial phases.
• Oversee the collection, analysis, and interpretation of clinical trial data, coordinating closely with Clinical Development, Biostatistics, and Data Management to maintain data integrity.
• Contribute to the preparation and review of key clinical documents, including the Investigator Brochure, IND, protocols, clinical study reports, and updates to regulatory filings.
• In collaboration with the Head of Clinical Operations, build and develop the Clinical Operations team, fostering a culture of collaboration, accountability, and continuous improvement.

• BA/BS in a health-related field; MA/MS in biological, life sciences, nursing, or related field preferred.
• 10+ years of clinical operations experience in the pharmaceutical or biotechnology industry.
• Proven experience in team building and leadership.
• Deep knowledge of global regulatory and compliance requirements, including US CFR, EU CTD, and ICH GCP guidelines.
• Strong ability to manage multiple priorities and adapt to a fast-paced environment.
• Excellent communication, interpersonal, and problem-solving skills.

This is a full-time position.