Senior Director, Clinical Operations / Head of Clinical Operations

Location: Remote (Boston area preferred)

Reports To: Chief Medical Officer

Position Overview

Our client is a clinical-stage biotechnology company advancing an innovative therapeutic platform and conducting global clinical trials across multiple phases of development. The company is seeking a Senior Director, Head of Clinical Operations to lead the operational execution of ongoing and planned global studies.

This is a senior, hands-on leadership role for an experienced Clinical Operations professional who can oversee CROs, guide operational strategy, and partner closely with Clinical Development, Project Management, Finance, and Quality. The ideal candidate brings deep global trial experience, strong vendor oversight capabilities, and the ability to balance strategic input with day-to-day execution.

Key Responsibilities

Clinical Trial Operations & CRO Oversight

• Provide overall leadership and oversight of the operational conduct of international clinical studies (Phases I–IV).
• Oversee CROs and vendors across all operational aspects of clinical trials.
• Ensure studies are conducted in compliance with protocols, ICH-GCP, and applicable regulatory requirements.

Vendor Selection, Budgeting & Planning

• Participate in CRO and vendor selection, RFP processes, and contract/budget negotiations.
• Collaborate with Project Management, Finance, and Clinical Development on budget projections and resource planning.
• Own enrollment projections and feasibility planning for clinical studies.

Site & Investigator Collaboration

• Provide operational input into site selection in collaboration with the CMO and Head of Clinical Development.
• Work directly with investigative sites on operational matters.
• Identify enrollment or site-level risks and propose practical mitigation strategies.

Informed Consent & Study Documentation

• Oversee the informed consent process, including internal review and approval of the Master ICF.
• Collaborate with Clinical Development and Medical leadership to ensure accuracy, consistency, and regulatory appropriateness.

Monitoring, Data & Reporting

• Review and oversee clinical monitoring reports.
• Oversee CRO-led data entry, data cleaning, data review, and database lock activities.
• Ensure data quality, inspection readiness, and alignment with development strategy.

Risk Management & Quality Collaboration

• Proactively identify operational risks and drive mitigation planning.
• Collaborate with Quality Assurance on site and vendor audits.
• Support inspection readiness and audit activities.

Leadership & Governance

• Provide regular management updates via dashboards, reports, and presentations.
• Contribute to the development and refinement of Clinical Operations SOPs.
• Support additional projects as required in a growing, dynamic organization.

Qualifications

Required

• Advanced degree (Master’s, PhD, or equivalent).
• 5+ years of Clinical Operations experience in biotech or pharma.
• Demonstrated experience leading global clinical trials.
• Strong expertise across CRO oversight, vendor management, clinical monitoring, and data management.
• Deep knowledge of ICH-GCP and global clinical trial regulations.
• Ability to operate effectively in a remote, cross-functional environment.

Preferred

• Prior experience at a Senior Director or Head of Clinical Operations level.
• Background in small or emerging biotech companies.
• Strong executive communication and stakeholder-management skills.