Associate Director Clinical Operations

Our On-Demand Talent Solutions team is seeking an experienced Sr. Clinical Trial Manager to support our client, a clinical-stage biotechnology company advancing its first wholly owned asset into Phase 1 clinical trials.

Summary: This individual will lead and manage the operational aspects of clinical trials and partner with cross-functional teams to execute the company's clinical strategy. The ideal candidate will bring strong expertise in early-phase clinical trials and a passion for advancing innovative therapies.

Responsibilities:

• Oversee the scope, quality, timelines, and budget for early- and/or late-stage clinical trials, ensuring studies are initiated efficiently and completed on time, within budget, and in compliance with regulatory requirements.
• Lead one or more study execution teams and oversee the development and review of clinical and data management documents.
• Communicate expectations to CROs, ensure appropriate site management and compliance with project plans, hold CROs accountable to timelines, and verify quality metrics.
• Anticipate obstacles and complex issues at the site, vendor, and study levels; proactively identify issues for escalation and implement solutions and risk mitigation strategies.
• Build efficient and scalable study management and quality processes, ensuring the quality and integrity of clinical data through data listing reviews.
• Drive the development of work instructions and SOPs, and provide study-specific training and leadership to clinical research staff.

Qualifications:

• Bachelor's degree in Natural or Health Sciences (Biology, Pharmacology, Pharmaceutical Sciences, or equivalent) preferred.
• 10+ years of clinical operations experience, preferably with both early- and late-stage immunology clinical trials.
• Strong knowledge of the clinical trial process, including working knowledge of all functional areas of clinical trials and regulatory requirements; prior inspection readiness experience preferred.
• Strong project management, organizational, and problem-solving skills, with experience overseeing clinical trial execution and operational deliverables.