Revolution Medicines
Senior Safety Scientist
Revolution Medicines, San Francisco, California, United States, 94199
Overview
Senior Safety Scientist role at Revolution Medicines. 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 includes RAS(ON) Inhibitors 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 Revolutionaries in a commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity:
The Senior Safety Scientist within Global Patient Safety Science is an individual contributor who provides safety science and pharmacovigilance support to all products across the RevMed portfolio, including early and late-phase development activities. The role includes safety oversight of clinical studies, review and authoring of clinical trial protocols, Investigator’s Brochure (IB), informed consent forms (ICF), and DSURs. Additional activities involve medical review of individual case safety reports (ICSRs), safety surveillance of assigned products, and active participation in cross-functional teams. The Senior Safety Scientist will develop and maintain an understanding of the safety profile of the assigned product(s). Responsibilities
Proactive medical safety surveillance of ongoing clinical trials for identification and management of safety issues. Prepare and present safety data summaries to internal and external stakeholders. Risk management activities including medical review of ICSRs, routine review of safety data and pertinent scientific literature. Acquire and contribute knowledge of relevant drug class and/or competitor safety issues. Identify potential clinical safety issues and recommend appropriate risk mitigation measures. Involvement in preparation and maintenance of sections of clinical trial protocols, IBs (including the reference safety information section), ICFs, DSURs, risk management plans (RMPs), CCDS, and labeling as required. Perform safety reviews of clinical protocols, IBs, ICFs and related documents to align with the safety strategy and risk communication. Accountable for safety components of study reports (CSRs), publications, aggregate reports, and other regulatory documents. Conduct signal detection and evaluation activities for assigned products, contributing to ongoing benefit-risk evaluations and escalation to safety governance committees as needed. Support implementation of decisions from signal evaluation, including updates to core safety information and safety documents. Contribute input related to regulatory filings (NDAs, BLAs) and responses to safety queries from third parties, such as regulatory agencies. Establish and maintain collaborative relationships with study team members, CROs, investigators, study sites, vendors, and committees. Ensure compliance with governing laws, RevMed SOPs, and other guidelines. Required Skills, Experience and Education
A relevant postgraduate qualification (e.g., MD, PharmD, PhD/MSc in a Life sciences discipline, or other post-graduate health professional qualifications). 3 or more years of drug development experience in the pharmaceutical or related industry with at least 1 year in drug safety. Proven ability to build strong relationships with internal and external partners to foster positive partnerships. Broad understanding of safety science, PV (including GVP, GCP), and clinical/patient risk management and safety operations. Demonstrated ability to lead and influence in a fast-paced environment. Strong presentation skills and ability to summarize and present key considerations and decisions. Collaborative, innovative, and proactive approach in a high-energy setting. Detail-oriented with the ability to prioritize tasks and work independently as appropriate. Strong organizational skills with ability to interpret, discuss, and report trial-level data and identify trends. Excellent written and verbal communication skills. Compensation and Benefits
The base salary range for this full-time position is $158,000 to $198,000 for candidates working onsite at our headquarters in Redwood City, CA. The range reflects onsite roles in Redwood City and will be adjusted for the local market. Individual pay is determined by role, level, location, and other factors. Please note that base salary is part of the total rewards program, which includes competitive cash compensation, equity awards, benefits, and learning opportunities. Equal Opportunity
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. We take protection and security of personal data seriously and respect your privacy while using our website and when contacting us. We collect and use personal data in accordance with our CCPA Notice and Privacy Policy. For more information, please contact privacy@revmed.com.
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Senior Safety Scientist role at Revolution Medicines. 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 includes RAS(ON) Inhibitors 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 Revolutionaries in a commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity:
The Senior Safety Scientist within Global Patient Safety Science is an individual contributor who provides safety science and pharmacovigilance support to all products across the RevMed portfolio, including early and late-phase development activities. The role includes safety oversight of clinical studies, review and authoring of clinical trial protocols, Investigator’s Brochure (IB), informed consent forms (ICF), and DSURs. Additional activities involve medical review of individual case safety reports (ICSRs), safety surveillance of assigned products, and active participation in cross-functional teams. The Senior Safety Scientist will develop and maintain an understanding of the safety profile of the assigned product(s). Responsibilities
Proactive medical safety surveillance of ongoing clinical trials for identification and management of safety issues. Prepare and present safety data summaries to internal and external stakeholders. Risk management activities including medical review of ICSRs, routine review of safety data and pertinent scientific literature. Acquire and contribute knowledge of relevant drug class and/or competitor safety issues. Identify potential clinical safety issues and recommend appropriate risk mitigation measures. Involvement in preparation and maintenance of sections of clinical trial protocols, IBs (including the reference safety information section), ICFs, DSURs, risk management plans (RMPs), CCDS, and labeling as required. Perform safety reviews of clinical protocols, IBs, ICFs and related documents to align with the safety strategy and risk communication. Accountable for safety components of study reports (CSRs), publications, aggregate reports, and other regulatory documents. Conduct signal detection and evaluation activities for assigned products, contributing to ongoing benefit-risk evaluations and escalation to safety governance committees as needed. Support implementation of decisions from signal evaluation, including updates to core safety information and safety documents. Contribute input related to regulatory filings (NDAs, BLAs) and responses to safety queries from third parties, such as regulatory agencies. Establish and maintain collaborative relationships with study team members, CROs, investigators, study sites, vendors, and committees. Ensure compliance with governing laws, RevMed SOPs, and other guidelines. Required Skills, Experience and Education
A relevant postgraduate qualification (e.g., MD, PharmD, PhD/MSc in a Life sciences discipline, or other post-graduate health professional qualifications). 3 or more years of drug development experience in the pharmaceutical or related industry with at least 1 year in drug safety. Proven ability to build strong relationships with internal and external partners to foster positive partnerships. Broad understanding of safety science, PV (including GVP, GCP), and clinical/patient risk management and safety operations. Demonstrated ability to lead and influence in a fast-paced environment. Strong presentation skills and ability to summarize and present key considerations and decisions. Collaborative, innovative, and proactive approach in a high-energy setting. Detail-oriented with the ability to prioritize tasks and work independently as appropriate. Strong organizational skills with ability to interpret, discuss, and report trial-level data and identify trends. Excellent written and verbal communication skills. Compensation and Benefits
The base salary range for this full-time position is $158,000 to $198,000 for candidates working onsite at our headquarters in Redwood City, CA. The range reflects onsite roles in Redwood City and will be adjusted for the local market. Individual pay is determined by role, level, location, and other factors. Please note that base salary is part of the total rewards program, which includes competitive cash compensation, equity awards, benefits, and learning opportunities. Equal Opportunity
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. We take protection and security of personal data seriously and respect your privacy while using our website and when contacting us. We collect and use personal data in accordance with our CCPA Notice and Privacy Policy. For more information, please contact privacy@revmed.com.
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