Associate Director Clinical Operations

Stevenson Search Partners; San Francisco (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Stevenson Search Partners is seeking a Sr. Clinical Trial Manager to lead the operational aspects of early- and late-stage trials and partner with cross-functional teams to execute the company’s clinical strategy. The role requires deep expertise in clinical trial processes and regulatory readiness.

The position demands strong project management to deliver studies on time and within budget while maintaining data integrity and compliance.

Qualifications

• 10+ years of clinical operations experience, preferably with both early- and late-stage immunology clinical trials.
• Strong knowledge of the clinical trial process and regulatory requirements; inspection readiness experience preferred.
• Strong project management and organizational skills.

Responsibilities

• Oversee scope, quality, timelines, and budget for early- and/or late-stage trials.
• Lead one or more study execution teams and oversee the development and review of clinical and data management documents.
• Communicate expectations to CROs and ensure site management and compliance with project plans.
• Anticipate obstacles at site, vendor, and study levels; identify issues for escalation and implement risk mitigation.
• Build scalable study management and quality processes; ensure data integrity through data listings reviews.
• Drive development of work instructions and SOPs; provide study-specific training to clinical staff.

Skills

Clinical operations

Project management

Regulatory compliance

Cross-functional teamwork

Education

Bachelor's degree in Natural or Health Sciences

Job description

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.