Study Manager, Toxicology

Socket.dev; United States; On-site; USD 143,000 - 178,000; Full time

Job summary

Revolution Medicines is seeking a Preclinical Study Manager to oversee non-GLP and GLP toxicology studies from research to late clinical development. You will act as the primary RevMed contact to CROs, ensuring scientific and corporate objectives are achieved and regulatory guidelines are followed.

Responsibilities include coordinating cross-functional teams, reviewing protocols and reports, and supporting regulatory submissions.

Qualifications

• BS degree in science; 5+ years in biotech/pharma/CRO industries.
• Experience with GLP/ICh/FDA guidelines for drug development.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Design protocols with CROs to meet scientific objectives.
• Monitor non-GLP and GLP toxicology studies and ensure objectives are met.
• Review study protocols, reports, and amendments for quality.
• Coordinate activities across RevMed teams and CROs to meet timelines.
• Analyze data and generate results tables/graphs as needed.
• Contribute to regulatory submissions for nonclinical sections.

Skills

Protocol design

Study monitoring

Protocol review

Cross-functional coordination

Data analysis

Regulatory submissions

Relationship building

QA collaboration

Contract negotiation

Education

BS in science

Job description

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

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:

• Work with Contract Research Organizations (CROs), internal subject matter experts, and toxicologists to help design protocols that achieve the scientific objectives of each study.
• Monitor non-GLP and GLP toxicology studies through effectively managing day-to-day study-related activities and ensure study objectives are met against project goals.
• Assist toxicologists in the review of protocols, study reports, and protocol/report amendments to ensure high-quality results are generated by CROs.
• Coordinate study-related activities between RevMed personnel (toxicologists, Project Management, CMC, Bioanalytical, Regulatory, Finance, and Legal groups), and CROs to ensure program needs and timelines are met.
• Assist with data analysis and generate results tables and graphs as needed.
• Participate in regulatory submissions (e.g. 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.
• Negotiate contracts and manage internal approvals & execution process.
• Support the development and/or review of SOPs, policies, and guidelines.
• 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. #LI-Remote #LI-CT1

Base Pay Salary Range

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].

$143,000—$178,000 USD