Director, Clinical Operations

Relay Therapeutics; Cambridge (MA); On-site; USD 250,000 - 400,000; Full time

Job summary

Relay Therapeutics is seeking a Director of Clinical Operations to lead global breast cancer studies from concept to final report. You will manage cross-functional teams, CRO partners, and ensure data integrity while meeting timelines and budgets.

You will provide operational input on protocol design, site selection and enrollment strategy, and you will mentor clinical study staff while maintaining inspection readiness and adherence to GCP and regulatory standards.

Qualifications

• 10+ years of experience in biopharma or CRO and leading global studies.
• Led global Phase 2 and/or Phase 3 oncology studies end to end; registrational experience preferred.
• Breast cancer or solid tumor oncology experience is a plus.
• Hands-on CRO and vendor oversight including contracting, budget management and governance.
• Strong knowledge of global regulatory and compliance requirements (US CFR, EU CTR, ICH GCP) and inspection support.
• Proven ability to meet aggressive timelines using data and problem-solving to accelerate enrollment and data integrity.
• Lead through influence, align across functions and external partners, and communicate with senior leaders.
• Line management or team leadership experience and mentoring of staff.

Responsibilities

• Serve as Global Study Lead for assigned breast cancer studies from concept through start-up, enrollment, database lock and final report.
• Lead cross-functional study teams and CRO partners; drive priorities and escalate risks.
• Provide operational input to protocol design, site selection and enrollment strategy.
• Own study timelines, budget, forecasts, risks and KPIs; deliver data-driven status updates to leadership.
• Select, contract and oversee CROs and vendors with governance and performance oversight.
• Drive enrollment and site performance across a global footprint; implement recruitment strategies.
• Maintain relationships with investigators and key opinion leaders in breast oncology.

Skills

Study leadership

Global trial management

CRO oversight

Regulatory knowledge

Budget management

Cross-functional leadership

Data-driven decisions

Communication with leadership

Education

Bachelor's degree

Advanced degree preferred

Job description

As Director, Clinical Operations – Global Study Lead, you will be accountable for the end-to-end planning and execution of one or more global studies within Relay Tx’s breast cancer (BC) program. You will lead cross-functional study teams and CRO partners to deliver registrational-quality studies with speed, rigor and data integrity. You will be an integrated member of the BC clinical development team, bringing operational insight to study design and program strategy, and translating Relay’s innovative science into impactful medicines for patients with breast cancer. You will report to the Vice President, Clinical Operations.

Your Role:

• You will serve as the Global Study Lead, accountable for the delivery of assigned BC studies from protocol concept through study start-up, enrollment, database lock and clinical study report, on time, on budget and to quality.
• You will lead the cross-functional study team (Clinical Science, Medical, Biostatistics, Data Management, Clinical Supply, Regulatory, Safety, Quality and Translational), setting clear priorities, driving decisions and escalating risks appropriately.
• You will bring operational and feasibility input to protocol design, country and site selection, and enrollment strategy, ensuring study plans are aligned with the BC clinical development strategy and corporate goals.
• You will own the study’s integrated timelines, budget, forecasts, risk and mitigation plans, and key performance metrics, and provide clear, data-driven status updates to program and senior leadership.
• You will select, contract and oversee CROs and specialty vendors (e.g., central lab, imaging, IRT, eCOA), holding partners accountable for performance and quality through governance and active issue management.
• You will drive enrollment and site performance across a global footprint (North America, Europe and other regions), using data and creative recruitment and retention approaches to accelerate timelines.
• You will build and maintain strong relationships with investigators, key opinion leaders, site staff and cooperative groups in the breast oncology community, and be able to explain complex scientific and operational topics to these stakeholders.
• You will 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/preventive actions.
• You will contribute the Clinical Operations sections of key regulatory and study documents (e.g., protocols and amendments, IND/CTA submissions, briefing packages, NDA/MAA components, annual reports, study postings and clinical study reports).
• You will partner with Clinical Operational Excellence to apply and improve study systems, processes and SOPs, and share lessons learned across the BC program and the broader Clinical Operations team.
• You will lead, coach and develop clinical study managers, clinical trial associates and other study team members, and serve as a leadership role model within Clinical Development Operations.

Your Background:

• You bring 10+ years of experience in the biopharma or CRO industry, including significant experience leading global studies as a study lead or equivalent.
• You have led global Phase 2 and/or Phase 3 oncology studies end to end; experience with registrational studies is strongly preferred.
• You have breast cancer or solid tumor oncology experience; familiarity with endocrine therapy, targeted therapy combinations, or the metastatic breast cancer treatment landscape is a plus.
• You have a track record of hands-on CRO and vendor oversight in an outsourced model, including contracting, budget management and performance governance.
• You have strong, current knowledge of global regulatory and compliance requirements, including US CFR, EU CTR, and ICH GCP, and have supported inspections or audits.
• You have a proven ability to deliver to aggressive timelines, using data, technology and creative problem-solving to accelerate enrollment and maintain data integrity.
• You lead through influence, building alignment across functions and with external partners, and you communicate clearly and confidently with senior leaders, investigators and vendors.
• You are a motivated self-starter who flourishes in a fast-paced, growing biotech environment and can manage multiple priorities with a high degree of attention to detail.
• You have line management or team leadership experience and enjoy mentoring and developing talent.
• Bachelor’s degree in a scientific or health-related field required; advanced degree preferred.

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About Relay Therapeutics

Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world‑class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process.

Our team is equal partsfearlessandrelentless, with a shared passion for working collaboratively in intellectually stimulating environments. If you’re excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us!

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