Clinical Program Manager

3 weeks ago

Redwood City, United States REVOLUTION Medicines Full time

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit 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:

This is a unique opportunity for a Clinical Operations Professional. As a Clinical Program Manager (CPM), you will be responsible for acting as a central contact for the Clinical Study Team(s) and assist with the execution and management of Revolution Medicines (RevMed) clinical trials.

  • 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 the successful management of all aspects of clinical trials within timelines and designated program budgets
  • Partner with cross-functional teams to manage, adjust, and revise project timelines and budgets as needed
  • Analyze data health metrics to be shared with stakeholders
  • Actively partner with cross-functional teams and vendors to drive the query resolution and data listings review process to meet objectives in a timely and efficient process
  • Conduct risk management, contingency, and scenario planning
  • Supervise, communicate project status/issues, and problem solve to ensure project team goals are met
  • Participate in the development of all study-related documentation, including study protocols
  • Actively contributes in the selection and management of contract research organizations (CROs) and/or vendors, including development of requests for proposals (RFPs)
  • Use all available tools to track, oversee, and communicate on program status to all key stakeholders
  • Participate in other Clinical Operations activities as appropriate
  • Leads a larger, more complex trial with some oversight from senior members of Clinical Operations
  • With minimal support, lead cross-functional Clinical Study Execution Team (CSETs)
  • Participate in and contribute to SOP development, implementation, and training
  • Support junior team members through mentorship
Required Skills, Experience and Education:
  • RN or Bachelor's or Master's degree in biological sciences or health-related field required
  • 8+ years direct Clinical Operations experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research-related experience. Relevant indirect experiences may also meet the requirement.
  • Minimum of 4 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
  • 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, Experience and Education:
  • 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 mentoring jr staff.

The base salary range for this full-time position is $120,000 to $158,000 for candidates based at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the minimum and maximum salary for the position in Redwood City and will be adjusted for the local market a candidate is based. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

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. 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 privacy@revmed.com.

#LI-Hybrid #LI-DN1

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