Director, Clinical Operations
Collegium Pharmaceutical, Inc.
August 12, 2026
Remote friendly (Stoughton, MA)
United States
Clinical Research and Development
Position Overview:
This position is responsible for the strategic planning, financial oversight, and end-to-end execution of clinical trials while ensuring compliance with regulatory, quality, and internal standards. Oversees CROs and external vendors, manages cross-functional study teams, supports data integrity, and drives operational efficiencies to deliver studies on time, within approved budgets, and with high quality.
Responsibilities:
- Formulate operational execution strategies for Phase I–IV clinical programs.
- Own operational delivery from protocol development through completion of the clinical study report.
- Develop and maintain integrated study timelines and milestones.
- Identify and mitigate clinical trial risks with corrective actions.
- Drive site selection and patient recruitment strategies.
- Determine drug supply assumptions and ensure adequate drug supply at sites.
- Lead identification, selection, and oversight of CROs/external vendors/trial sites.
- Serve as primary oversight contact for CRO and vendor partnerships.
- Lead contract and budget negotiations for clinical vendors.
- Track CRO/vendor metrics and performance; manage clinical trial budgets and forecast costs.
- Develop/review clinical protocols, investigator brochures, clinical development plans, and regulatory submission components.
- Ensure study documents (plans, CRFs, listings/tables/figures, study reports) are accurate, complete, and aligned with objectives and regulations.
- Ensure compliance with GCP/ICH/FDA and applicable requirements.
- Maintain inspection readiness for trial master files and study documentation.
- Lead development/review of clinical SOPs and operational processes.
- Collaborate as a core member of cross-functional study teams; provide guidance/mentoring to partners and study team members.
- Ensure seamless internal/external communication with CROs and trial sites.
Qualifications:
- B.A. or B.S.; at least 8 years of clinical trial experience in pharma/biotech, including leading/overseeing clinical trial execution.
- In-depth clinical operations expertise; knowledge of FDA regulations and ICH-GCP.
- Expertise in budgeting, financial tracking, and contract negotiation.
- Strong organizational, problem-solving, and operational management skills.
- Effective verbal and written communication across organizational levels.
- Proven cross-functional collaboration.
- 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
This position is responsible for the strategic planning, financial oversight, and end-to-end execution of clinical trials while ensuring compliance with regulatory, quality, and internal standards. Oversees CROs and external vendors, manages cross-functional study teams, supports data integrity, and drives operational efficiencies to deliver studies on time, within approved budgets, and with high quality.
Responsibilities:
- Formulate operational execution strategies for Phase I–IV clinical programs.
- Own operational delivery from protocol development through completion of the clinical study report.
- Develop and maintain integrated study timelines and milestones.
- Identify and mitigate clinical trial risks with corrective actions.
- Drive site selection and patient recruitment strategies.
- Determine drug supply assumptions and ensure adequate drug supply at sites.
- Lead identification, selection, and oversight of CROs/external vendors/trial sites.
- Serve as primary oversight contact for CRO and vendor partnerships.
- Lead contract and budget negotiations for clinical vendors.
- Track CRO/vendor metrics and performance; manage clinical trial budgets and forecast costs.
- Develop/review clinical protocols, investigator brochures, clinical development plans, and regulatory submission components.
- Ensure study documents (plans, CRFs, listings/tables/figures, study reports) are accurate, complete, and aligned with objectives and regulations.
- Ensure compliance with GCP/ICH/FDA and applicable requirements.
- Maintain inspection readiness for trial master files and study documentation.
- Lead development/review of clinical SOPs and operational processes.
- Collaborate as a core member of cross-functional study teams; provide guidance/mentoring to partners and study team members.
- Ensure seamless internal/external communication with CROs and trial sites.
Qualifications:
- B.A. or B.S.; at least 8 years of clinical trial experience in pharma/biotech, including leading/overseeing clinical trial execution.
- In-depth clinical operations expertise; knowledge of FDA regulations and ICH-GCP.
- Expertise in budgeting, financial tracking, and contract negotiation.
- Strong organizational, problem-solving, and operational management skills.
- Effective verbal and written communication across organizational levels.
- Proven cross-functional collaboration.
- 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