Director, Clinical Operations

Hybrid (required onsite in Stoughton, MA on Tuesday, Wednesday, and Thursday).

Strategic planning, financial oversight, and end-to-end execution of clinical trials, ensuring compliance with regulatory, quality, and internal standards. Oversees CROs/vendors and cross-functional study teams; supports data integrity and operational efficiencies to deliver studies on time, within budget, and to high quality.

• Formulate operational execution strategies for Phase I–IV clinical programs.
• Own operational delivery from protocol development through clinical study report completion.
• Develop and maintain integrated study timelines and milestones.
• Identify/interpret trial risks and implement mitigation/corrective actions.
• Lead site selection and patient recruitment strategies.
• Determine drug supply assumptions and ensure adequate drug supply to sites.
• Lead CRO/vendor and trial site selection, oversight, and performance tracking.
• Serve as primary oversight contact for CRO/vendor partnerships.
• Lead contract and budget negotiations; manage and forecast clinical trial budgets.
• Develop/review protocols, investigator brochures, development plans, and regulatory document portions.
• Ensure study documents (plans, CRFs, outputs, CSRs) are complete, accurate, and aligned with objectives/regulatory requirements.
• Ensure compliance with protocols, plans, GCP, ICH, FDA, and other applicable requirements; maintain inspection readiness.
• Lead development and continuous improvement of clinical SOPs and operational processes.
• Collaborate with internal stakeholders; mentor external partners/contractors/study team members; ensure effective two-way communication.

• B.A./B.S. + at least 8 years clinical trial experience in pharma/biotech, including leading/overseeing execution.
• Clinical operations expertise; in-depth FDA regulations and ICH-GCP.
• Budgeting/financial tracking and contract negotiation expertise.
• Strong organizational, problem-solving, operational management, and cross-functional collaboration.
• Effective verbal/written communication.
• Flexibility to adapt to changing needs.
• Proficiency with Microsoft Office (Excel, Outlook, PowerPoint, Word) and EDC systems.

Pay Range: $215,000 USD - $253,000 USD