Senior Clinical Program Manager, Clinical Operations
About the role
The Opportunity: Join a tireless team dedicated to patients with RAS-addicted cancers. You will adhere to SOPs, GCP, and ICH guidelines, leading clinical trials and collaborating with cross-functional teams.
Responsibilities
- Adhere to Clinical Standard Operating Procedures (SOP), Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines.
- Be a team leader, providing guidance and oversight for clinical trials within timelines and budget constraints.
- Analyze data health metrics and share insights with stakeholders.
- Partner with cross-functional teams to manage, adjust, and revise project timelines and budgets.
- Conduct risk management, contingency, and scenario planning.
- Supervise, communicate project status/issues, and problem solve to ensure project team goals are met.
- Lead the development of all study-related documentation, including study protocols.
- Select and manage contract research organizations (CROs) and/or vendors, including development of requests for proposals (RFPs).
- Track, oversee, and communicate on program status to all key stakeholders.
- Independently lead Clinical Study Execution Teams (CSETs) and influence relevant stakeholders both internally and externally.
- Develop and retain top talent within the team.
- Coach direct report(s) on their performance, development, and career interests.
- Participate in other Clinical Operations activities as appropriate.
Requirements
- RN or Bachelor’s or Masters degree in biological sciences or health-related field required.
- 10+ years direct Clinical Operations experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research-related experience.
- Minimum of 6 years of cross-functional study management or related leadership experience in life sciences, including multiple years’ experience managing project teams.
- Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP.
- Proven ability to successfully start-up, manage, and close-out clinical trials, including authoring clinical study and regulatory documentation and SOPs.
- Experience in selection of CROs/vendors and management of external resources.
- Collaborative team setting, flexible, and driven by innovation.
- Solution-oriented, proactive in risk assessment and mitigation.
- Excellent written/verbal communication and interpersonal skills.
- High sense of priority and commitment to excellence.
- Proficient in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.
- Travel may be required (~25%).
Qualifications
- Familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).
- Oncology experience, early and/or late stage, strongly preferred.
- Knowledge and/or familiarity with Ex-US region(s) clinical trial operations.
- Some experience managing direct reports.
Benefits
Base Pay Salary Range: $164,000 - $205,000 USD
Pay
Base Pay Salary Range: $164,000 - $205,000 USD
Schedule
Full-time position
Company Information
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), elironrasib (RMC-6291), zoldonrasib (RMC-9805), and RMC-5127, are currently in clinical development.
Contact Information
For additional information, please contact privacy@revmed.com. 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.