Senior Clinical Program Manager

revolutionmedicines; Redwood City (CA); Sur place; USD 150 000 - 210 000; Plein temps

Résumé du poste

Revolution Medicines is seeking a Senior Clinical Program Manager to act as the central contact for Clinical Study Teams and drive execution of oncology trials. You will lead timelines, budgets, and CRO/vendor management while partnering with cross-functional teams to ensure data quality and project success.

This role requires extensive Clinical Operations experience, strong regulatory knowledge, and the ability to mentor junior staff in a fast-paced, high-energy oncology environment.

Qualifications

• RN or Bachelor’s or Master’s degree in biological sciences or health-related field.
• 10+ years direct Clinical Operations experience in pharma/biotech.
• Minimum of 6 years cross-functional study management or leadership in life sciences.
• Experience in Oncology Trials.
• Strong knowledge of FDA regulations, ICH guidelines, and GCP.

Responsabilités

• Act as central contact for Clinical Study Teams and assist with trial execution and management.
• Lead and oversee clinical trials within timelines and program budgets.
• Partner with cross-functional teams and vendors to manage timelines and budgets.
• Analyze data health metrics for stakeholders.

Connaissances

RN or Bachelor’s or Master’s in life/生

Formation

RN or Bachelor’s or Master’s in biological sciences

Outils

MS Project

Smartsheet

Microsoft Excel

Description du poste

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 Senior 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.

• Adhere to Clinical Standard Operating Procedures (SOP), Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guideline.
• 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 Masters degree in biological sciences or health-related field required.
• 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.
• Minimum of 6 years of cross-functional study management or related leadership experience in life sciences, including multiple years' experience managing project teams.
• Experience in Oncology Trials.
• 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:

• 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 pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the