Senior Clinical Program Manager

Revolution Medicines, Inc.; Redwood City (CA); Presencial; USD 164.000 - 205.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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%).

Responsabilidades

• 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.

Conocimientos

Cross-functional leadership

FDA/ICH/GCP knowledge

Oncology trials

Project management

Vendor management

Data analysis

Communication

MS Office

Travel readiness

Educación

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

Herramientas

MS Project

Smartsheet

Descripción del empleo

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.

#LI-DN1 #LI-Hybrid
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 base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.

Base Pay Salary Range
$164,000—$205,000 USD