Temp, Associate Director, Clinical Operations Compliance & Training (San Francis
Revolution Medicines, San Francisco
Temp, Associate Director, Clinical Operations Compliance & Training
Join to apply for the Temp, Associate Director, Clinical Operations Compliance & Training role at Revolution Medicines
Temp, Associate Director, Clinical Operations Compliance & Training
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Join to apply for the Temp, Associate Director, Clinical Operations Compliance & Training role at Revolution Medicines
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys 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 Re in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
Revolution Medicines is seeking a Temporary Associate Director, Clinical Operations Compliance & Training, who will play a key role within Clinical Operations and is responsible for providing compliance support for RevMed sponsored clinical trials with respect to RevMeds Standard Operating Procedures, Good Clinical Practice (GCP), applicable regulatory requirements, and current industry standards and practices.
- SME for Clinical Operations personnel for issues relating to GCP, best practices, SOPs, non-compliance, etc.
- Support Clinical Operations Inspection Readiness initiatives.
- Support the development, revision, and continuous improvement of Clinical Operations SOPs, Work Instructions/Policies in compliance with GCP, RevMed standards, and regulatory requirements.
- Contribute to the development and execution of Clinical Operations training programs.
- Other assigned Clinical Operations activities, as appropriate.
- RN or bachelors or masters degree in biological sciences or health-related field required.
- 10+ years in GCP Quality Assurance, Clinical Compliance, and/or Clinical Operations experience in the pharmaceutical or biotech industry.
- Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP
- Strong background in Inspection Readiness activities.
- Demonstrated experience developing and authoring Clinical and cross-functional SOPs.
- Outstanding organizational skills with the ability to multi-task and prioritize.
- Excellent interpersonal, verbal, and written communication skills, with ability to interact with colleagues and partners at all levels of experience.
- Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities.
- Demonstrated proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint, Visio); MS Project and/or Smartsheet a plus.
- Travel may be required (~25%)
- Oncology experience, early and/or late stage preferred.
- Strong working knowledge of ex-US regulations and requirements
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 the 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 .
Seniority level
Seniority level
Director
Employment type
Employment type
Full-time
Job function
Job function
Research, Analyst, and Information Technology
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