Third Rock Ventures-posted 2 months ago
Mid Level
Redwood City, CA
Securities, Commodity Contracts, and Other Financial Investments and Related Activities

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. 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. This is a unique opportunity for a Clinical Program Manager (CPM). You will be responsible for driving operational strategy across multiple trials within entire clinical programs or multiple trials across indications, and support program-level governance, timelines, and decision-making. This position will report into the Senior Director, Clinical Operations.

  • Provide expert thought leadership at the discipline level on highly complex and business critical assignments and begins to develop new ideas.
  • Lead the Clinical Study Execution Team (CSET) meetings and ensure trial timelines are met.
  • Develop trial execution strategy and timelines across study(ies).
  • Participate in multiple department or interdepartmental strategic initiatives under limited supervision as it relates to study-specific initiatives.
  • May serve as a resource for others with regard to a specific study trial.
  • Maintain audit/inspection readiness and oversee TMF compliance.
  • Collaborate with cross functional partners in drafting study documents such as protocols, ICFs, CRFs, monitoring plans, etc.
  • Drive consistency in processes and tools across studies.
  • Contribute to development of RFPs and participates in selection of CROs/vendors.
  • May be asked to train CROs, vendors, investigators, and study coordinators, as well as cross-functional partners on study requirements.
  • Oversee CROs, vendors, and key external partners to ensure study delivery.
  • Make recommendations to the development of study-level budget.
  • Participate in the recruiting and hiring process.
  • Mentor and train Clinical Trial Managers (CTMs), Clinical Trial Management Associates (CTMAs), and Clinical Trial Assistants (CTAs).
  • Conduct risk management, contingency, and scenario planning.
  • Participate in other Clinical Operations activities as appropriate.
  • BS, BA, or RN in a relevant scientific discipline.
  • 8+ 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.
  • High-level cross-functional collaboration; strategic thinking across trials and functions.
  • Strategic thinking across clinical trials and functions with strong program-level planning and risk management.
  • Independently apply clinical trials knowledge to problems that arise during the conduct of a study.
  • 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.
  • Travel may be required (~25%).
  • 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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