Head of Clinical Operations

Stevenson Search Partners; United States; On-site; USD 221,000 - 369,000; Full time

Job summary

Stevenson Search Partners is seeking a Head of Clinical Operations Consultant to lead the existing Clinical Operations team and stay hands-on in study execution within a fully outsourced model.

You will drive startup and execution across Phase 1–2 trials, mentor staff, and oversee CROs and vendors to ensure timelines, quality, budgets, and data delivery.

Qualifications

• 12+ years of progressive Clinical Operations experience within biotech, pharmaceutical, and/or CRO environments.
• Senior Director, VP, Head of Clinical Operations, or equivalent leadership experience.
• Strong experience with early-stage Phase 1 and Phase 2 clinical trials, including hands-on startup and execution.
• Extensive CRO and vendor management experience within a fully outsourced model.
• Strong knowledge of ICH-GCP and applicable clinical trial regulations.

Responsibilities

• Drive startup and execution across four Phase 1–2 clinical trials, including two studies currently in startup and two additional studies planned for Q1 2027.
• Lead study activities from operational planning and design through startup, enrollment, and execution, stepping into CTM-level responsibilities when additional operational support is required.
• Lead and mentor existing Clinical Operations team members while driving study timelines, operational plans, budgets, risk-mitigation strategies, and enrollment plans.
• Oversee CROs, sites, and vendors, ensuring accountability for timelines, quality, budgets, and deliverables, and identify and engage new partners as needed.
• Provide operational leadership for a key Phase 1 clinical pharmacology/healthy volunteer study, ensuring timely data delivery to inform an ongoing Phase 2 program.
• Partner cross-functionally with Clinical Development, Regulatory, CMC, Data Management/Biostatistics, Safety, and external consultants.
• Support early clinical development and regulatory activities, including IND-related documentation and regulatory meeting materials.

Skills

Leadership

Vendor management

Study startup

ICH-GCP

Phase 1/2 trials

Cross-functional collaboration

Job description

Our On-Demand Talent Solutions team is excited to announce that we are hiring a Head of Clinical Operations Consultant to support our client’s early-stage clinical development programs! The ideal candidate is a player-coach, leader, mentor, and is comfortable stepping into CTM-level activities as needed.

Summary

The Head of Clinical Operations will be responsible for leading the existing Clinical Operations team and providing senior-level oversight while remaining hands-on in study execution within a fully outsourced model.

Responsibilities

• Drive startup and execution across four Phase 1–2 clinical trials, including two studies currently in startup and two additional studies planned for Q1 2027.
• Lead study activities from operational planning and design through startup, enrollment, and execution, stepping into CTM-level responsibilities when additional operational support is required.
• Lead and mentor existing Clinical Operations team members while driving study timelines, operational plans, budgets, risk-mitigation strategies, and enrollment plans.
• Oversee CROs, sites, and vendors, ensuring accountability for timelines, quality, budgets, and deliverables, and identify and engage new partners as needed.
• Provide operational leadership for a key Phase 1 clinical pharmacology/healthy volunteer study, ensuring timely data delivery to inform an ongoing Phase 2 program.
• Partner cross-functionally with Clinical Development, Regulatory, CMC, Data Management/Biostatistics, Safety, and external consultants.
• Support early clinical development and regulatory activities, including IND-related documentation and regulatory meeting materials.

Qualifications

• 12+ years of progressive Clinical Operations experience within biotech, pharmaceutical, and/or CRO environments.
• Senior Director, VP, Head of Clinical Operations, or equivalent leadership experience.
• Strong experience with early-stage Phase 1 and Phase 2 clinical trials, including hands‑on study startup and execution.
• Extensive CRO and vendor management experience within a fully outsourced model.
• Strong knowledge of ICH-GCP and applicable clinical trial regulations.