Senior Clinical Program Manager

Revolution Medicines•Redwood City, CA

2d•$164,000 - $205,000•Hybrid

About The Position

Revolution Medicines is seeking a Senior Clinical Program Manager to serve as a central contact for Clinical Study Teams and support the execution and management of clinical trials. The role leads larger, more complex trials with some oversight from senior Clinical Operations members and, with minimal support, leads cross-functional Clinical Study Execution Teams (CSETs). The manager is accountable for successful trial management within timelines and designated program budgets, while adhering to Clinical Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and International Council for Harmonisation (ICH) guidelines. The position partners with cross-functional teams and vendors to manage timelines and budgets, assess data health metrics, drive query resolution and data-listing review, and conduct risk, contingency, and scenario planning. It also contributes to study documentation, including protocols, and to SOP development, implementation, and training. The manager supports CRO and vendor selection and management, communicates program status and issues to stakeholders, solves problems, and mentors junior team members. Travel may be required, approximately 25%. The role is listed as hybrid and is based on a full-time salary range of $164,000–$205,000 USD; the stated range is for candidates working onsite at headquarters in Redwood City, California, and is adjusted for local market.

Requirements

RN, bachelor's degree, or master's degree in biological sciences or a health-related field.
10+ years of direct Clinical Operations experience in the pharmaceutical or biotech industry; Clinical Operations or Clinical Research-related experience preferred. Relevant indirect experience may also meet the requirement.
At least 6 years of cross-functional study management or related leadership experience in life sciences, including multiple years managing project teams.
Experience in oncology trials.
Strong working knowledge of FDA regulations, ICH guidelines, and GCP.
Demonstrated ability to start up, manage, and close out clinical trials, including authoring clinical study and regulatory documentation and SOPs.
Experience selecting CROs and vendors and managing external resources.
Ability to work collaboratively and flexibly in a fast-paced, high-energy environment and support innovative approaches and technologies.
Solution-oriented approach, including anticipating obstacles and proactively providing risk assessment and mitigation strategies.
Excellent written and verbal communication and interpersonal skills.
Strong sense of priority and commitment to excellence in executing deliverables.
Ability to analyze operational data with attention to quality, timeliness, and fiscal responsibility; make and drive decisions; multitask and prioritize; anticipate challenges; and execute goals as part of an interdisciplinary team.
Proficiency in Microsoft Office Suite, including Outlook, Word, Excel, and PowerPoint.
Travel may be required, approximately 25%.

Nice To Haves

Familiarity with vendor systems and portals such as eTMF, EDC, IRT, and CTMS.
Oncology experience in early- and/or late-stage trials.
Knowledge of or familiarity with clinical trial operations in ex-U.S. regions.
Experience mentoring junior staff.
Experience with MS Project and/or Smartsheet.

Responsibilities

Serve as a central contact for Clinical Study Teams and assist with execution and management of clinical trials.
Lead larger, more complex trials with some oversight from senior Clinical Operations members.
Lead cross-functional Clinical Study Execution Teams (CSETs) with minimal support.
Provide guidance and oversight for trial management to meet timelines and designated program budgets.
Partner with cross-functional teams to manage, adjust, and revise project timelines and budgets.
Analyze data health metrics and share them with stakeholders.
Partner with cross-functional teams and vendors to drive query resolution and data-listing review in a timely and efficient manner.
Conduct risk management, contingency planning, and scenario planning.
Supervise, communicate project status and issues, and solve problems to ensure project-team goals are met.
Participate in developing study-related documentation, including study protocols.
Contribute to selecting and managing CROs and vendors, including developing requests for proposals (RFPs).
Use available tools to track, oversee, and communicate program status to key stakeholders.
Participate in other Clinical Operations activities as appropriate.
Contribute to SOP development, implementation, and training.
Support junior team members through mentorship.
Adhere to Clinical SOPs, GCP, and ICH guidelines.