Senior Study Manager, Toxicology

Revolution Medicines; United States; On-site; USD 150,000 - 189,000; Full time

Job summary

Revolution Medicines is seeking a Preclinical Study Manager to oversee GLP and non-GLP toxicology studies, coordinating with CROs and internal experts to ensure scientific and regulatory objectives are met.

Based onsite in Redwood City, CA, the role offers a base pay range of $150,000–$189,000 USD per year, with responsibilities including protocol reviews, milestone tracking, and cross-functional collaboration across QA, Regulatory, and Project Management. Some travel may be required.

Qualifications

• Experience managing day-to-day study activities with CROs and internal experts to design and monitor GLP and Non-GLP toxicology studies.
• Assistance in protocol and report review for external studies to ensure high-quality CRO deliverables.
• Coordinate nonclinical study activities with toxicologists and internal groups to meet program needs and timelines.
• Track nonclinical milestones against project goals; participate in regulatory submissions.

Responsibilities

• Manage day-to-day study activities with CROs and internal experts.
• Assist toxicologists in protocol and report reviews for external studies.
• Coordinate nonclinical studies with cross-functional teams (PM, CMC, Bioanalytical, Regulatory, Finance, Legal).
• Track milestones against project goals and timelines.
• Support regulatory submissions and preparation/review of nonclinical sections in IBs/NDAs/BLAs.
• Develop and maintain relationships with study directors and collaborators.
• Work with QA on CRO vendor selection and audits.
• Negotiate contracts/SOWs and approval processes.
• Support SOPs, policies, and guidelines development.

Skills

Study coordination

CRO liaison

Regulatory submissions

Project management

ICH/FDA knowledge

Education

BS degree in science

Job description

Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.

Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients.

The Opportunity

The preclinical study manager is responsible for the operational activities associated with performing non-GLP and GLP toxicology studies from research to late phases of clinical development. This includes being the primary operational contact and representative for RevMed to the contract research organization (CRO) performing each study. He/she will be responsible for ensuring that each study’s scientific and corporate objectives are achieved, and are compliant with appropriate regulations, policies, standard operating procedures, and all relevant international regulatory guidelines/regulations. Timely resolution of study-related issues, liaising with internal experts and/or consultants, and informing appropriate personnel are pivotal to being successful in this role.

Required Skills, Experience and Education

• Effectively manage day-to-day study related activities and work with Contract Research Organizations (CROs), internal subject matter experts, and toxicologists to help design and develop protocols, and monitor GLP and Non-GLP toxicology studies required for preclinical testing of drug candidates.
• Assisting toxicologists in the review of protocols, study reports, and protocol/report amendments for external studies to ensure high quality deliverables from CROs.
• Coordination of study-related activities with toxicologists and other internal groups supporting nonclinical studies (eg, Project Management, CMC, Bioanalytical, Regulatory, Finance, and Legal), and CROs to ensure program needs and timelines are met.
• Tracking nonclinical study milestones against project goals.
• Participation in regulatory submissions (eg, preparation and/or review applicable nonclinical sections of IBs, NDAs, BLAs, etc.)
• Develop and maintain relationships with study directors, principal investigators, and external collaborators.
• Work with QA to facilitate CRO vendor selection/audit and due diligence activities.
• Negotiating contracts/SOWs and process for approval/full execution.
• Supports development and/or review of SOPs, policies, and guidelines.
• At least a BS degree in science and 8+ years of experience in biotech, pharmaceutical and/or CRO.
• Have current knowledge of ICH and FDA guidelines.
• Strong interpersonal skills and ability to work with cross-functional project teams and CROs.
• Effective communicator, both verbally and in writing, and ability to facilitate open cross-functional collaboration.
• Ability to prioritize responsibilities and meet deadlines.
• Ability to self-motivate and work independently.
• Ability to travel to CRO partners as needed.
• Other duties will be assigned as needed.

Preferred Skills

• BS degree in science and minimum 5+ years of relevant experience in biotech, pharmaceutical and/or CRO industries.
• Knowledge of current GLP regulations, and ICH and FDA guidelines for drug development.
• Strong interpersonal skills and ability to work with cross-functional project teams and CROs.
• Effective communication, both verbally and in writing, and ability to facilitate open cross-functional collaboration.
• Ability to prioritize responsibilities and meet deadlines.
• Self-motivated and independent work ethics.
• Ability to travel to CRO partners as needed.

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact [e-mail].

Base Pay Salary Range

$150,000 - $189,000 USD