What are the responsibilities and job description for the Pre-Clinical Operations Manager position at Revolution Medicines?
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit high-value frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. 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 Pre-Clinical Operations Manager is responsible for the operational activities associated with performing non-GLP and GLP toxicology studies related to RevMed pipeline development. This includes being the primary operational contact for the study director at the conract research organization (CRO) performing each study. Additionally, he/she will be responsible for ensuring that the studies are compliant with appropriate regulations, policies, standard operating procedures, and all relevant international regulatory guidelines/regulations. Resolution of study-related issues, liasing with internal experts and/or consultants, and informing appropriate personnel in a timely manner is pivotal to the performance of this role.
- 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.
- Travel to CROs to monitor study critical phases as needed.
- 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.
- Other duties will be assiged as needed.
Required Experience, Skills, and Education:
- At least a BS degree in science and 5 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.
- Excellent written and oral communication skills.
- Ability to prioritize responsibilities and meet deadlines.
- Ability to self-motivate and work independently.
- Ability to travel to CRO partners as needed.