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Senior Clinical Program Manager

Senior Clinical Program Manager

Revolution MedicinesRedwood City, CA, US
30+ days ago
Job type
  • Full-time
Job description

Senior Clinical Program Manager

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. 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 Senior Clinical Program Manager (Sr. CPM). You will be responsible for providing strategic clinical operations leadership across a portfolio of trials, ensuring operational excellence and full accountability for trial execution. This position will report into the Associate Director, Clinical Operations.

Responsibilities

  • Apply extensive industry experience and exercise wide latitude in determining objective and approve significantly complex, multi-discipline or function-wide assignments.
  • Oversee the execution of the Clinical Study Execution Team (CSET) meetings and provide strategic context and clarity where needed.
  • Oversee operational delivery across multiple study(ies).
  • Lead multiple departmental or interdepartmental strategic initiatives as it relates to broader organizational topics. Known as the subject matter expert and point of contact for specific study trial(s).
  • Ensure inspection readiness and quality compliance.
  • Provide operational input into protocol design, study documents, and regulatory submissions.
  • Ensure alignment and consistency across trial teams, vendors, and systems.
  • Oversee the development of RFPs and selection of CROs / vendors.
  • Trian CROs, vendors, investigators, and study coordinators, as well as cross-functional partners on study requirements.
  • Oversee vendor management develop strong collaborative relationship with internal and external stakeholders.
  • Review, approve, and manage study-level budget and drive cost control.
  • Identify resourcing needs and lead the recruiting and hiring process, as well as make the decision for hiring.
  • Mentor and train Clinical Program Managers (CPMs), Clinical Trial Managers (CTMs), Clinical Trial Management Associates (CTMAs), and Clinical Trial Assistants (CTAs).
  • Manage individual contributors including performance management.
  • Conduct risk management, contingency, and scenario planning.
  • Participate in other Clinical Operations activities as appropriate.

Required Skills, Experience and Education

  • BS, BA, or RN in a relevant scientific discipline.
  • 10+ years of relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research related experience.
  • Expert knowledge of FDA and EMA Regulations, ICH Guidelines, GCP, and familiarity with standard clinical operating procedures.
  • Effective cross-functional team management.
  • Strong project leadership and decision-making with advanced problem-solving and communication skills.
  • Manage studies or programs of higher complexity from both a process and strategic perspective.
  • High sense of priority and commitment to excellence in the successful execution of deliverables.
  • Successful experience with teams analyzing operational data, emphasis on quality, timeliness and fiscal responsibility, lead decision making, anticipate challenges, and execute on goals as the leader of an interdisciplinary team.
  • Travel may be required (~25%).
  • Preferred Skills

  • Decision-making skills.
  • Has familiarity working with vendor systems / portals (e.g., eTMF, EDC, IRT, CTMS).
  • Oncology experience, early and / or late stage, strongly preferred.
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    Senior Program Manager • Redwood City, CA, US

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