Director, Clinical Operations
Collegium Pharmaceutical, Inc.
August 11, 2026
Remote friendly (Boston, MA)
United States
Clinical Research and Development
Hybrid (required onsite in Stoughton, MA on Tuesday, Wednesday, and Thursday).
POSITION OVERVIEW
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.
RESPONSIBILITIES
- 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.
QUALIFICATIONS
- 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
POSITION OVERVIEW
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.
RESPONSIBILITIES
- 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.
QUALIFICATIONS
- 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