New · posted Nov 11
Relay Therapeutics · Biotechnology
Director, Clinical Operations
- Cambridge, MA
- On-site
- Full-time
- Director
The role
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 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.
What you need
Skills named in this posting
What you'll do
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.
Where you'll work
Cambridge, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Cambridge, MA
From the posting
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 parts fearless and relentless, 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!
Job intelligence
The context around this role
Live data · November 11, 2026
Salary intelligence
How the pay compares
Director roles in Massachusetts8 roles publishing pay
Director roles in the US41 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| Massachusetts (middle half) | $194,125 | $200,000 | $221,125 |
| All US (middle half) | $202,000 | $233,000 | $244,000 |
Comparisons: the base pay employers published on open Clinical Operations roles at the same level on Regulatory Jobs, November 11, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Operations
The general path across 102 open Clinical Operations roles on Regulatory Jobs, with the titles they carry most. Not Relay Therapeutics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 22 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Clinical trial conduct11
- Collaboration and leadership10
- Documentation and SOPs5
- Investigations and CAPA3
- Data and digital systems3
- GMP and compliance2
- Regulatory submissions1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Operations work in biotechnology, led by the three this posting names, each linked to the agency or standards body that publishes it.
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trialsNamed in the posting
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trialsNamed in the posting
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)Named in the posting
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- ICHICH E8(R1)(official source, opens in a new tab)General considerations for clinical studies and quality by design in trials
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- ICHICH E3(official source, opens in a new tab)Structure and content of clinical study reports
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- HHS45 CFR Part 46 (Common Rule)(official source, opens in a new tab)The federal policy for the protection of human research subjects
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
Company hiring pulse
Relay Therapeutics on Regulatory Jobs
- 5
- Open roles
- 5
- Distinct roles
- 1
- Locations
By discipline
- Clinical3 60%
- Regulatory2 40%
By level
- Director5 100%
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Director, Clinical Operations at Relay Therapeutics
Open until filled.