Clinical Program Manager
Confirmed live in the last 24 hours
Revolution Medicines
Compensation
$143,000 - $178,000/year
Job Description
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 Revolutionaries 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.
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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 contributes 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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Participate in other Clinical Operations activities as appropriate.
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Leads a larger, more complex trial with some oversight from senior members of Clinical Operations.
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With minimal support, lead cross-functional Clinical Study Execution Team (CSETs).
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Participate in and contribute to SOP development, implementation, and training.
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Support junior team members through mentorship.
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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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.
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Minimum of 4 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 successf
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