Senior Oncology Clinical Programs Lead

Revolution Medicines, Inc.; Redwood City (CA); On-site; USD 164,000 - 205,000; Full time

Job summary

Revolution Medicines, Inc. is seeking a Senior Clinical Program Manager to act as the central contact for Clinical Study Team(s) and drive execution of clinical trials. You will lead cross-functional teams, manage timelines and budgets, and coordinate with CROs/vendors in a fast-paced oncology setting.

The role requires 10+ years in Clinical Operations, strong FDA/ICH/GCP knowledge, and experience in start-up, management, and close-out of trials. Travel up to ~25% is expected.

Qualifications

• RN or Bachelor’s or Masters degree in biological sciences or health-related field required.
• 10+ years direct Clinical Operations experience in pharma/biotech.
• Minimum of 6 years cross-functional study management or related leadership experience.
• Experience in Oncology Trials.
• Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP.
• Proven ability to start-up, manage, and close-out clinical trials, including regulatory documentation and SOPs.
• Experience in selection of CROs/vendors and management of external resources.
• Ability to lead cross-functional Clinical Study Execution Team (CSETs).
• Travel may be required (~25%).

Responsibilities

• Act as central contact for Clinical Study Team(s) and assist with execution and management of clinical trials.
• Adhere to SOP, GCP, and ICH guidelines.
• Lead and oversee management of trials within timelines and budgets.
• Partner with cross-functional teams to manage timelines and budgets.
• Analyze data health metrics for stakeholders.
• Drive query resolution and data listings review with CROs/vendors.
• Conduct risk management, contingency, and scenario planning.
• Supervise and communicate project status and solve problems.
• Participate in development of study-related documentation and SOPs.
• Evaluate and manage CROs/vendors and RFPs.
• Track and communicate program status to stakeholders.
• Lead larger, more complex trials and mentor junior members.
• Support SOP development and training.

Skills

Cross-functional leadership

FDA/ICH/GCP knowledge

Oncology trials

Project management

Vendor management

Data analysis

Communication

MS Office

Travel readiness

Education

RN or Bachelor’s or Masters in biological sciences/health-related field

Tools

MS Project

Smartsheet

Job description

Revolution Medicines, Inc. is seeking a Senior Clinical Program Manager to act as the central contact for Clinical Study Team(s) and drive execution of clinical trials. You will lead cross-functional teams, manage timelines and budgets, and coordinate with CROs/vendors in a fast-paced oncology setting.

The role requires 10+ years in Clinical Operations, strong FDA/ICH/GCP knowledge, and experience in start-up, management, and close-out of trials. Travel up to ~25% is expected.