Clinical Program Manager (CPM) - Clinical Operations

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