Senior Clinical Program Manager

Job description

Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.

Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients.

The Opportunity:

This is a unique opportunity for a Clinical Operations Professional. As a Sr. Clinical Program Manager, 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.

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Adhere to Clinical Standard Operating Procedures (SOP), Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines.

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Be a team leader, providing guidance and oversight for the successful management of all aspects of clinical trials within timelines and designated program budgets.

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Partner with cross-functional teams to manage, adjust, and revise project timelines and budgets as needed

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Analyze data health metrics to be shared with stakeholders.

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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.

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Conduct risk management, contingency, and scenario planning.

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Supervise, communicate project status/issues, and problem solve to ensure project team goals are met.

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Participate in the development of all study-related documentation, including study protocols.

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Actively contribute in the selection and management of contract research organizations (CROs) and/or vendors, including development of requests for proposals (RFPs).

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Use all available tools to track, oversee, and communicate on program status to all key stakeholders.

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Demonstrate the ability to lead and manage multiple complex clinical trials within one or multiple programs with limited oversight.

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Independently lead Clinical Study Execution Team (CSETs) and influence relevant stakeholders both internally and externally including management.

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May lead interdepartmental strategic business initiatives as well as spearhead certain SOP development and training.

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May provide input into strategic and operational short- and long-term therapeutic area development, as appropriate, including supporting alignment and communication to other team members upon implementation

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Assists in the hiring, development, and retention of top talent within the team. Coach direct report(s) on their performance, development, and career interests.

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Participate in other Clinical Operations activities as appropriate.

Required Skills, Experience and Education:

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RN or Bachelor’s or Masters degree in biological sciences or health-related field required.

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10+ 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.

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Minimum of 6 years of cross-functional study management or related leadership experience in life sciences, including multiple years’ experience managing project teams.

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Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP.

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Proven ability to successfully start-up, manage, and close-out clinical trials, including authoring clinical study and regulatory documentation and SOPs.

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Experience in selection of CROs/vendors and management of external resources.

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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.

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Be solution-oriented by anticipating obstacles and difficulties, and proactively providing risk assessment and mitigation strategies to achieve project goals.

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Excellent written/verbal communication and interpersonal skills.

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High sense of priority and commitment to excellence in the successful execution of deliverables.

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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.

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Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.

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Travel may be required (~2

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