Director, Clinical Operations

Relay Therapeutics•Cambridge, MA

About The Position

The Director, Clinical Operations – Global Study Lead is accountable for end-to-end planning and execution of one or more global studies within Relay Therapeutics’ breast cancer program. The role leads cross-functional study teams and CRO partners to deliver high-quality, registrational-quality studies with speed, rigor, data integrity, and compliance. It is an integrated member of the breast cancer clinical development team, contributing operational insight to study design and program strategy and translating the company’s science into medicines for patients. The position reports to the Vice President, Clinical Operations. The Global Study Lead is responsible for assigned studies from protocol concept through start-up, enrollment, database lock, and clinical study report, delivering on time, on budget, and to quality. The role owns study timelines, budgets, forecasts, risk and mitigation plans, and performance metrics; oversees CROs and specialty vendors; and drives enrollment and site performance across North America, Europe, and other regions. It also supports regulatory and study documentation, inspection readiness, operational excellence, and the development of clinical study team members. Relay Therapeutics is a clinical-stage precision medicines company focused on transforming drug discovery and developing therapies for patients. Its Dynamo platform integrates experimental and computational approaches to understand protein structure and motion, with an initial focus on targeted oncology and small molecule discovery. The company describes its team as collaborative and intellectually engaged.

Requirements

10+ years of experience in the biopharma or CRO industry, including significant experience leading global studies as a study lead or equivalent.
Experience leading global Phase 2 and/or Phase 3 oncology studies end to end.
Breast cancer or solid tumor oncology experience.
Track record of hands-on CRO and vendor oversight in an outsourced model, including contracting, budget management, and performance governance.
Strong, current knowledge of global regulatory and compliance requirements, including US CFR, EU CTR, and ICH GCP; experience supporting inspections or audits.
Ability to deliver against aggressive timelines using data, technology, and creative problem-solving while accelerating enrollment and maintaining data integrity.
Ability to lead through influence and build alignment across functions and with external partners.
Clear and confident communication with senior leaders, investigators, and vendors.
Self-starter able to manage multiple priorities with attention to detail in a fast-paced, growing biotech environment.
Line management or team leadership experience and interest in mentoring and developing talent.
Bachelor’s degree in a scientific or health-related field.

Nice To Haves

Experience with registrational studies is strongly preferred.
Familiarity with endocrine therapy, targeted therapy combinations, or the metastatic breast cancer treatment landscape is a plus.
Advanced degree preferred.

Responsibilities

Lead assigned breast cancer global studies from protocol concept through study start-up, enrollment, database lock, and clinical study report, ensuring delivery on time, on budget, and to quality.
Lead cross-functional study teams across Clinical Science, Medical, Biostatistics, Data Management, Clinical Supply, Regulatory, Safety, Quality, and Translational functions; set priorities, drive decisions, and escalate risks.
Provide operational feasibility input to protocol design, country and site selection, and enrollment strategy, aligning plans with the breast cancer clinical development strategy and corporate goals.
Own integrated study timelines, budgets, forecasts, risks and mitigation plans, and key performance metrics; provide data-driven updates to program and senior leadership.
Select, contract, and oversee CROs and specialty vendors, including central laboratories, imaging, IRT, and eCOA providers; manage partner performance and quality through governance and issue management.
Drive enrollment and site performance across global regions using data and recruitment and retention approaches to accelerate timelines.
Build and maintain relationships with investigators, key opinion leaders, site staff, and cooperative groups in the breast oncology community, explaining scientific and operational topics to stakeholders.
Ensure inspection readiness and compliance with GCP, ICH, and applicable global regulations, including oversight of the Trial Master File, monitoring strategy, protocol deviations, and corrective and preventive actions.
Contribute Clinical Operations content to protocols and amendments, IND/CTA submissions, briefing packages, NDA/MAA components, annual reports, study postings, and clinical study reports.
Partner with Clinical Operational Excellence to apply and improve study systems, processes, and SOPs, and share lessons learned across the breast cancer program and Clinical Operations.
Lead, coach, and develop clinical study managers, clinical trial associates, and other study team members; serve as a leadership role model within Clinical Development Operations.