10+ years in biopharma or CRO industry with global study leadership experience
Experience leading global Phase 2 and/or Phase 3 oncology studies, preferably registrational
Background in breast cancer or solid tumor oncology, with knowledge of treatment landscapes
Hands-on experience with CRO and vendor oversight, including contracting and budget management
Strong knowledge of global regulatory requirements (US CFR, EU CTR, ICH GCP)
Proven ability to meet aggressive timelines using data and creative problem-solving
Experience in team leadership and talent development
Bachelor's degree in a scientific or health-related field; advanced degree preferred
Responsibilities
Serve as Global Study Lead for breast cancer studies from protocol concept to clinical study report
Lead cross-functional study teams, setting priorities and driving decisions
Provide operational input to protocol design and enrollment strategy
Own study timelines, budgets, forecasts, and key performance metrics
Select and oversee CROs and specialty vendors, ensuring accountability for performance
Drive global enrollment and site performance using data-driven strategies
Build relationships with investigators and key opinion leaders in the oncology community
Ensure compliance with GCP, ICH, and global regulations, overseeing inspection readiness
Contribute to regulatory and study documents, including protocols and IND submissions
Partner with Clinical Operational Excellence to improve study systems and processes
Lead and mentor clinical study managers and team members
Benefits
Opportunity to lead impactful global studies in breast cancer
Collaborative work environment with cross-functional teams
Access to cutting-edge research and innovative therapies
Professional development and mentorship opportunities
Engagement with key opinion leaders and industry experts
Full Job Description
The Opportunity:
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 biotechnology company that develops new medicines using computational techniques. The company's platform combines computational simulations with experimental data to design new drugs that target specific proteins. Relay Therapeutics' technology can help accelerate the drug discovery process and reduce the time and cost of bringing new drugs to market. The company was founded in 2016 and is based in Cambridge, Massachusetts.
