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Senior Study Manager – Toxicology Operations
| Company | Revolution Medicines |
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| Location | San Carlos, CA, USA |
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| Salary | $144000 – $180000 |
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| Type | Full-Time |
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| Degrees | Bachelor’s, Master’s |
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| Experience Level | Expert or higher |
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Requirements
- BS or MS degree in science and 10+ 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.
Responsibilities
- 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 Qualifications
- Experience with scientific data management and informatics software (Benchling, D360).
- Experience with project management software (smartsheet).
