Director, Clinical Operations

The role

You will be accountable for the end-to-end planning and execution of global breast cancer studies. You will lead cross-functional study teams and CRO partners to deliver registrational-quality studies.

What you will do

• Deliver assigned BC studies from protocol concept through study start-up, enrollment, database lock and clinical study report.
• Lead the cross-functional study team by setting priorities and driving decisions.
• Provide operational and feasibility input to protocol design, site selection, and enrollment strategy.
• Own study timelines, budget, forecasts, risk and mitigation plans.
• Select, contract and oversee CROs and specialty vendors.
• Drive enrollment and site performance across a global footprint.
• Build and maintain relationships with investigators, key opinion leaders, site staff and cooperative groups.
• Ensure inspection readiness and compliance with GCP, ICH, and global regulations.
• Contribute to Clinical Operations sections of regulatory and study documents.
• Lead, coach and develop clinical study managers, clinical trial associates and other study team members.

Required qualifications

• 10+ years of experience in the biopharma or CRO industry, including significant experience leading global studies as a study lead or equivalent.
• Led global Phase 2 and/or Phase 3 oncology studies end to end.
• Track record of hands-on CRO and vendor oversight in an outsourced model.
• Strong, current knowledge of global regulatory and compliance requirements, including US CFR, EU CTR, and ICH GCP.
• Ability to deliver to aggressive timelines.
• Line management or team leadership experience.
• Bachelor’s degree in a scientific or health-related field.

Nice to have

• Experience with registrational studies
• Breast cancer or solid tumor oncology experience
• Familiarity with endocrine therapy, targeted therapy combinations, or the metastatic breast cancer treatment landscape
• Advanced degree

About the company

Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process. They use a Dynamo platform to integrate experimental and computational approaches to drug protein targets.