Temp Senior Clinical Program Manager, Compliance and Training

Revolution Medicines, Inc.; Redwood City (CA); On-site; USD 200,000 - 320,000; Full time

Job summary

Revolution Medicines is seeking a Sr. Clinical Program Manager to lead and advance Clinical Operations Compliance and Training. You will drive GCP infrastructure, author SOPs, and support inspection readiness across clinical trials in a fast-paced biotech environment.

The role requires 10+ years in clinical operations/compliance, deep FDA/GCP/ICH knowledge, and strong cross-functional collaboration. Some travel may be required as part of oversight and audits.

Qualifications

• 10+ years in Clinical Operations and/or Clinical Compliance in pharma/biotech.
• Experience developing and authoring Clinical SOPs ensuring GCP/regulatory compliance.
• Strong knowledge of FDA regulations, GCP and ICH guidelines.
• Excellent written/verbal communication and cross-functional collaboration.

Responsibilities

• Support GCP infrastructure and best industry practices within Clinical Operations.
• Develop and continuously improve Clinical Policies/SOPs/WIs/Templates in line with ICH/GCP and regulatory requirements.
• Manage oversight and inspection-readiness metrics across the clinical trial lifecycle.
• Support Clinical Operations Inspection Readiness activities.
• Contribute to Clinical Operations training programs on RevMed standards, GCP and regulatory requirements.
• Partner with QA on remediation plans, CAPAs and audit responses.
• Communicate deliverable status and solve problems to meet goals.
• Track project status and update key stakeholders.

Skills

FDA Regulations knowledge

GCP knowledge

ICH Guidelines knowledge

MS Office proficiency

Project management

Education

Biological/health sciences degree

Tools

MS Project

Smartsheet

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:

This is a unique opportunity for a Clinical Operations Compliance Professional. As a Sr. Clinical Program Manager (Sr. CPM), you will be in a key role in the Clinical Operations, Compliance and Training function in Revolution Medicines (RevMed) Clinical Operations to support the development and continuous improvement of GCP infrastructure using knowledge and experience with clinical study management, clinical compliance, clinical quality, International Conference on Harmonization (ICH) Guidelines, Good Clinical Practices (GCP) and regulatory requirements.

• Support Clinical Operations with GCP guidance and best industry practices.
• Lead or support the development and continuous improvement of Clinical Policies/ SOPs/ WIs/ Templates/etc. in compliance with International Conference on Harmonization (ICH) Guidelines, Good Clinical Practices (GCP) and regulatory requirements.
• Contribute to the management of business and compliance metrics to assess and continuously improve RevMed oversight and inspection readiness throughout the clinical trial lifecycle.
• Support Clinical Operations Inspection Readiness activities.
• Contribute to Clinical Operations training programs to deliver RevMed standards, GCP, and regulatory requirements.
• Partner cross-functionally and with QA on remediation plans and continuous improvement of GCP systems, investigations, CAPAs, and audit responses.
• Communicate deliverable status/issues, and problem solve to ensure functional goals are met.
• Use all available tools to track, oversee, and communicate on project status to all key stakeholders.
• Participate in other Clinical Operations Compliance & Training activities as assigned.

Required Skills, Experience and Education:

• RN or Bachelor’s or Masters degree in biological sciences or health-related field required.
• 10+ years (Sr. CPM) direct Clinical Operations and/or Clinical Compliance and/or Clinical Quality Assurance experience in the pharmaceutical or biotech industry or Clinical Research-related experience.
• Strong working knowledge of FDA Regulations, GCP, and ICH Guidelines, current industry practices.
• Demonstrated experience successfully developing and authoring Clinical and cross-functional SOPs ensuring compliance with GCP and regulatory requirements.
• Experience with development and monitoring of oversight activities.
• Thrives in a collaborative team setting that demonstrates flexibility required to maintain a fast pace and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
• Be solution-oriented by anticipating obstacles and difficulties and proactively providing risk assessment and mitigation strategies to achieve project goals.
• Excellent written/verbal communication and interpersonal skills.
• High sense of priority and commitment to excellence in the successful execution of deliverables.
• Ability to analyze operational data, contribute with a mind on quality, timeliness and fiscal responsibility, make and drive decisions, multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team.
• Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.
• Travel may be required (~25%).

Preferred Skills:

• Oncology experience, early and/or late stage.
• Knowledge and/or familiarity with Ex-US region(s) regulations and requirements.

This is a contract position that will be employed through a third-party recruiting agency. The agency will provide the pay range, which will be based on several factors, including job-related skills, experience, market conditions, and relevant education or training.

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 [e-mail].