Revolution Medicines

Senior Safety Scientist II

Redwood City, California, United States · Senior · Full-time

Sponsorship not specified$186k-$233kDetected 23 hours ago

GCPComplianceProduct ManagementClinical TrialsPharmacovigilanceCommunicationPublic SpeakingOrganizational Skills

About the role

The individual will be responsible for safety oversight of clinical studies, review and authoring of clinical trial protocols, IBs, ICFs, and DSURs.
Additional safety related activities will involve medical review of individual case safety reports (ICSRs), safety surveillance of assigned products and active member of cross-functional teams.
Proactive medical safety surveillance of ongoing clinical trials for identification and management of safety signals.

Perform safety review of clinical protocols, Investigator's Brochure (IB), informed consent form (ICF) and other related documents to ensure alignment with the safety strategy and ensure the appropriateness of risk management strategies and risk communication.
Accountable for the safety components of study reports (i.e., CSRs), publications, aggregate reports, and other regulatory documents.
Supports implementation of decisions from the signal evaluation process, including updates to core safety information, Investigator's Brochure and other key safety documents and deliverables.
Establish and maintain collaborative working relationships with all key stakeholders (study team members, CROs, investigators, study sites, vendors, committees, etc.).

Acquire and contribute knowledge of relevant drug class and/or competitor safety issues.
Involvement in preparation and maintenance of relevant sections of clinical trial protocols, IBs (including the reference safety information section), ICFs, DSURs, RMPs, CCDS, and labelling, as required.

5 or more years of drug development experience in the pharmaceutical or related industry with at least 3 years in drug safety.
Strong presentation skills, effective at summarizing and presenting the key considerations and decision points.
Detail-oriented with ability prioritize tasks and function independently as appropriate.
Strong organizational skills and an ability to interpret, discuss, and report trial level data effectively and identify trends.
Excellent written and verbal communication skills.

$186,000 - $233,000 USD
Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process.

A relevant postgraduate qualification (e.g., MD, PharmD, PHD/MSc in a Life sciences discipline, or other post-graduate health professional qualifications).
Risk management activities include, but are not limited to medical review of ICSRs, routine review of safety data and pertinent scientific literature articles.

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.

This listing is sourced directly from Revolution Medicines's careers page and normalized into a canonical job model.