Revolution Medicines
Director, Global Patient Safety Surveillance
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Director, Global Patient Safety Surveillance
About the Role
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s portfolio includes RAS(ON) inhibitors in clinical development, such as:
- Daraxonrasib (RMC-6236), a multi-selective inhibitor
- Elironrasib (RMC-6291), a G12C-selective inhibitor
- Zoldonrasib (RMC-9805), a G12D-selective inhibitor
- RMC-5127, a G12V-selective inhibitor
As a Principal Scientist of Safety Surveillance, you will join a team dedicated to advancing drug safety in the fight against cancers driven by RAS mutations.
The Opportunity
The role of Principal Scientist of Safety Surveillance is a leadership position within the Global Patient Safety (GPS) team, acting as a key subject matter expert for safety surveillance, pharmacovigilance (PV), and regulatory compliance processes. This individual will drive scientific innovation, lead key processes, and collaborate cross-functionally to ensure high-quality safety outputs in alignment with global regulatory requirements.
Responsibilities (Key Focus Areas)
Process Leadership & Compliance
- Lead or contribute to the design, development, maintenance, and support of core GPS processes, including:
- Safety risk management
- Signal detection and management
- Comparative benefit-risk assessment
- Aggregate reporting
- Ensure compliance with Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and Good Documentation Practices (GDocP).
- Overseer of outputs such as:
- Risk Management Plans (RMPs)
- Developmental Safety Update Reports (DSURs)
- Periodic Safety Update Reports (PSURs)
Expert Consultation & Regulatory Support
- Provide stakeholder consultation to Development and regulatory filing teams for PV components in:
- Clinical protocols
- Informed consent forms
- Investigator brochures
- NDA filing packages (Module 2, including Clinical Overview, Clinical Summary, Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), and safety narratives)
- Labeling strategy
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Documentation & Quality Systems
- Develop controlled documentation for GPS processes to demonstrate compliance and oversight.
- Contribute to the PV quality system in line with ICH, GCP, and GVP standards.
- Ensure inspection readiness for global audits and inspections, including acting as a subject matter expert (SME).
Strategic Influence & Innovation
- Drive strategic improvements in safety surveillance by proposing advances aligned with GPS mission and long-term goals.
- Innovate bespoke solutions for emerging safety challenges in healthcare.
- Collaborate with cross-functional teams to translate safety practices across the RevMed portfolio for consistency.
- Monitor and adapt to regulatory changes and trends in healthcare.
Stakeholder & External Partnerships
- Build collaborative partnerships with internal and external stakeholders, including development partners.
- Represent quality voice in cross-functional environments.
- Partner with the EU Qualified Person Responsible for Pharmacovigilance (QPPV) to ensure regulatory compliance.
- Engage with systems personnel in building/deploying fit-for-purpose PV tools.
Communication & Leadership
- Ensure clear communication of safety information to internal/external stakeholders.
- Influence and collaborate with policy governance bodies to adapt core processes.
- Foster growing innovation in processes via knowledge-sharing and best practices.
Required Skills & Experience
- Education: Advanced degree in Medicine (MD), Pharmacy (PharmD), or related field (e.g. PhD, MSc), or equivalent post-graduate health professional experience.
- Experience:
- 10+ years in pharmacovigilance (PV) or compliance within the pharmaceutical/biotech industry.
- Proven leadership in PV, with expertise managing global regulatory teams and processes.
- Technical & Regulatory Knowledge:
- Deep understanding of ICH guidelines, GxP, GVP, GCP, and robust compliance history.
- Advanced technical expertise in PV data analytics and systems.
- Soft Skills:
- Strong analytical, strategic, and problem-solving abilities.
- Excellent communication & team management, with influence at senior levels and external representation.
- High emotional intelligence, adaptability, and resilience.
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Preferred Skills (Plus Factors)
- Experience with advanced safety data analytics or specialized PV systems.
- Track record in complex project execution and matrixed organizations.
- Proficiency in managing regulatory interactions (e.g. FDA, EMA).
- BLA/MAA experience (“Biologics License Application” or Marketing Authorization Application).
- Time and organizational management skills for high-priority, multi-tasking environments.
About Revolution Medicines
Revolution Medicines prioritizes the protection of personal data and compliance with CCPA Notice and Privacy Policy. If you receive unsolicited communication from entities impersonating Revolution Medicines—a common recruitment scam—please report it to careers@revmed.com.
Note: All legitimate recruitment contact originates from official @revmed.com email addresses. Revolution Medicines will never:
- Ask for financial information or payment from candidates.
- Request the purchase of equipment as part of hiring.
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