Director, Clinical Operations

Scorpion Therapeutics; Stoughton (MA); On-site; USD 215,000 - 253,000; Full time

Job summary

Scorpion Therapeutics in Massachusetts is seeking a clinical operations leader to oversee end-to-end management of Phase I–IV trials, ensuring regulatory compliance and study quality.

You will coordinate CROs, manage study timelines, budgets, and vendor contracts, and mentor cross-functional teams to deliver on time and within approved budgets.

Qualifications

• Bachelor's degree (B.A. or B.S.) required.
• 8+ years of clinical trial experience in pharma/biotech.
• Strong knowledge of FDA regulations and ICH-GCP.

Responsibilities

• Formulate operational execution strategies for Phase I–IV clinical programs.
• Own operational delivery from protocol development through 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.
• Lead identification, selection, and oversight of CROs/external vendors/trial sites.

Skills

Clinical operations

Budgeting & forecasting

Cross-functional collaboration

Communication

Education

B.A./B.S. degree

Tools

Microsoft Office

EDC systems

Job description

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