Associate Director Clinical Operations

EPM Scientific; California; On-site; USD 180,000 - 240,000; Full time

Job summary

EPM Scientific is partnering with a clinical-stage biotechnology company seeking an Associate Director, Clinical Operations to provide strategic and operational leadership across global trials.

You will drive study execution from startup through closeout, mentor teams, and collaborate with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, Clinical Supply, and CRO partners to deliver on development programs, ensuring ICH-GCP compliance and FDA alignment.

Qualifications

• Bachelor's degree in Life Sciences or related field; advanced degree preferred.
• 8+ years of clinical operations experience in biotech/pharma/CRO environments.
• Global trials across EMEA and LATAM.
• Strong knowledge of ICH-GCP and FDA regulations; vendor oversight and trial execution.

Responsibilities

• Lead global Phase I-III clinical trials from startup through closeout.
• Drive study timelines, enrollment strategy, risk mitigation, and operational execution.
• Oversee CROs, vendors, and external partners to ensure quality delivery and compliance.
• Manage study budgets, milestones, and performance metrics.
• Partner cross-functionally to support clinical development objectives and program strategy.
• Ensure compliance with ICH-GCP, regulatory requirements, and internal SOPs.
• Mentor junior team members and contribute to process improvement initiatives.

Skills

Oncology experience

Cross-functional collaboration

Vendor oversight

Regulatory knowledge

Education

Bachelor's degree in Life Sciences

Advanced degree preferred

Job description

Our client is a clinical-stage biotechnology company developing innovative therapies for patients with serious and life-threatening diseases. Leveraging a cutting-edge discovery platform and world-class scientific leadership, the organization is advancing a robust pipeline while building a high-performing clinical development team.

About the Company

Our client is a clinical-stage biotechnology company developing innovative therapies for patients with serious and life-threatening diseases. Leveraging a cutting-edge discovery platform and world-class scientific leadership, the organization is advancing a robust pipeline while building a high-performing clinical development team.

As an Associate Director, Clinical Operations, you will provide strategic and operational leadership across global clinical trials, partnering closely with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, Clinical Supply, and CRO partners to ensure successful study execution.

What You'll Do

• Lead global Phase I-III clinical trials from startup through closeout.
• Drive study timelines, enrollment strategy, risk mitigation, and operational execution.
• Oversee CROs, vendors, and external partners to ensure quality delivery and compliance.
• Manage study budgets, milestones, and performance metrics.
• Partner cross-functionally to support clinical development objectives and program strategy.
• Ensure compliance with ICH-GCP, regulatory requirements, and internal SOPs.
• Mentor junior team members and contribute to process improvement initiatives.

About You

• Bachelor's degree in Life Sciences or related field; advanced degree preferred.
• Oncology experience required
• 8+ years of clinical operations experience within biotech, pharmaceutical, or CRO environments.
• Proven experience leading global clinical studies across multiple phases in EMEA and LATAM
• Strong knowledge of ICH-GCP, FDA regulations, vendor oversight, and clinical trial execution.
• Demonstrated ability to influence cross-functional teams and manage external partners.