Director, Global Patient Safety Surveillance

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development.

As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: The Principal Scientist of Safety Surveillance is a member of the Surveillance team serving as a lead principal subject matter expert for the design, development, maintenance, and support of core Global Patient Safety (GPS) processes. This individual will lead and/or contribute to safety development activities including scientific innovation and enablement across various disciplines relevant to clinical safety and pharmacovigilance, such as but not limited to safety risk management, signal detection management, comparative benefit-risk, and aggregate reporting.

Requirements

The Principal Scientist of Safety Surveillance will have robust and highly experienced understanding of the internal and external operating environment, which will enable anticipation of new developments and implementation of improvements critical to process maintenance and refinement at Revolution Medicines.

and following best practices. e. Module 2: Clinical Overview, Clinical Summary, Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), safety narratives), and labeling strategy.

Lead the development of controlled documentation required to demonstrate control and oversight of the PV aggregate reporting process and other processes as needed. Work with the EU Qualified Person Responsible for Pharmacovigilance (QPPV) to ensure European compliance as applicable. e.

GCP, GVP) enabling demonstration of quality, effectiveness, and control.

as applicable. Act as subject matter expert (SME) for audit and inspection for the assigned process(es). Drive development of controlled documentation for GPS owned processes as applicable and ensure that Safety’s voice is heard in cross-functional settings.

Responsibilities

e. , in alignment with the company’s mission and objectives. g.