Head of Clinical Operations

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.Qualifications12+ 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.