Principal Scientist, Global Patient Safety Surveillance at Revolution Medicines

Redwood City, California, United States -

Full Time

Start Date

Immediate

Expiry Date

29 Sep, 26

Salary

264000.0

Posted On

01 Jul, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmacovigilance, Signal Detection, Risk Management, Aggregate Reporting, Benefit-Risk Assessment, GCP, GVP, GDocP, Regulatory Compliance, Clinical Safety, Strategic Thinking, Project Management, Cross-functional Collaboration, Analytical Skills, Technical Writing, Audit Readiness

Industry

Hospitals and Health Care

Description

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. The Principal Scientist of Safety Surveillance supports Revolution Medicines to continuously deliver effective scientific safety activities and/or pharmacovigilance (PV) activities, in line with health authority and internal stakeholder 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. Responsibilities include: Serve as the lead principal subject matter expert for the design, development, maintenance, and support of one or more core GPS processes (i.e. comparative benefit-risk, signal detection & management, risk management, aggregate reporting, etc.) in compliance with applicable Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Documentation Practices (GDocP), etc., in alignment with the company’s mission and objectives. Manage the assigned core safety process(es) and support the execution/delivery of the required outputs (e.g. Risk Management Plans (RMPs), Developmental Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), etc.) in compliance with global regulatory requirements and following best practices. Provide expert consultation and direction for Development and filing teams where impactful as it relates to PV portions of regulatory reports and clinical study documents (including Clinical Protocols, Informed Consent Forms, Investigator Brochures, NDA filing packages (i.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. Contribute to the development and maintenance of a PV quality system in line with global regulations (i.e. GCP, GVP) enabling demonstration of quality, effectiveness, and control. Ensure inspection readiness for global inspections by ensuring processes and training reflect global regulatory requirements 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. Strategically influence, implement, improve, and innovate through the development of proposals that advance safety capabilities in line with the GPS mission, vision, goals, and long-term strategy. Create and implement bespoke solutions that enable GPS stakeholders to provide high-quality safety outputs that address emerging challenges in the healthcare practice setting against a dynamic regulatory landscape. Work in close partnership with cross-functional stakeholders and anticipate strategic requirements with respect to the assigned process(es). Maintain expert knowledge of key regulatory/legislative changes and trends in the evolving healthcare setting to anticipate future requirements and apply best practices in the assigned SME area(s). Translate/expand new and established safety approaches across the RevMed portfolio to enable consistent and high quality safety surveillance. Identify, share, and promote good practice innovation to enable continuous process improvement. Build relationships and collaborative partnerships for GPS and its cross-functional partners both internally and externally (i.e. with development partners). Collaboration and close interface with internal policy governance bodies in adapting core processes in line with business needs and external requirements. Ensure clear and effective communication of safety information to internal and external stakeholders. Partner with PV systems personnel in the development and implementation of fit for purpose PV systems. Required Skills, Experience and Education: Advanced degree in Medicine, Pharmacy, or a related field (MD, PharmD, PhD/MSc, or other post-graduate health professional qualification). Minimum of 10 years of experience in PV or related field within the pharmaceutical or biotechnology industry. Proven track record of leadership in PV. In-depth knowledge of global PV regulations and guidelines (i.e. ICH, GxP) and a record of compliance with these standards. Strong analytical and strategic thinking, problem-solving, and decision-making skills. Excellent communication, collaboration, and team management abilities, enabling exertion of strong and successful influence of senior executives as well as strong external representation for the company. Technical expertise in PV. Outstanding emotional intelligence. Preferred Skills: Experience with advanced safety data analytics and PV systems. Demonstrated ability to manage complex projects and work effectively in a matrixed organization. Proficiency in managing regulatory interactions. Strong organizational and time management skills, with the ability to prioritize and manage multiple tasks effectively. Excellent influence and collaboration/teamwork capabilities. BLA/MAA experience. #LI-SH1 #LI-Hybrid The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training. Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities. 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. Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. Base Pay Salary Range $211,000—$264,000 USD We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message. 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. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address. If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to careers@revmed.com so we can share these impersonations with our IT team for tracking and awareness.

Responsibilities

Lead the design and maintenance of core Global Patient Safety processes, including signal detection and aggregate reporting. Provide expert consultation for regulatory filings and ensure global compliance with pharmacovigilance standards.