Director, Clinical Operations

Scorpion Therapeutics; Boston (MA); Hybrid; USD 215,000 - 253,000; Full time

Benefits offered by this job

Hybrid work model

On-site in Stoughton, MA Tue-Thu

Competitive salary

Job summary

Scorpion Therapeutics in Boston area seeks an experienced Clinical Operations Lead responsible for end-to-end execution of multi-phase clinical programs. You will coordinate CROs, vendors, and study teams, ensuring data integrity, timelines, and budgets align with regulatory standards.

The role demands a BA/BS plus 8+ years; FDA/ICH-GCP knowledge is essential. Expect hybrid work with onsite collaboration in Stoughton, MA on Tue-Thu; strong cross-functional leadership is required.

Qualifications

• B.A./B.S. + at least 8 years clinical trial experience in pharma/biotech.
• Ability to lead and oversee execution across trials.
• Strong FDA/ICH-GCP knowledge and regulatory understanding.
• Budgeting, forecasting, and contract negotiation experience.

Responsibilities

• Formulate operational strategies for Phase I–IV programs.
• Own execution from protocol development to study report completion.
• Develop integrated study timelines and milestones.
• Lead CRO/vendor/site selection and oversight.
• Manage study budgets and contract negotiations.
• Ensure compliance with GCP, FDA, ICH and regulatory docs.

Skills

Budgeting/financial tracking

Cross-functional collaboration

Regulatory compliance

Communication skills

Problem solving

Education

B.S./B.A. degree in life sciences

Tools

EDC systems

Microsoft Office Suite

Job description

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