Revolution Medicines
Senior Director, Global Patient Safety Surveillance
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Senior Director, Global Patient Safety Surveillance
Senior Director of Safety Surveillance
Revolution Medicines
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—drugs designed to suppress diverse oncogenic variants of RAS proteins. The organisation’s RAS(ON) inhibitors include:
- Daraxonrasib (RMC-6236): A multi-selective inhibitor.
- Elironrasib (RMC-6291): Selective for G12C RAS mutations.
- Zoldonrasib (RMC-9805): Selective for G12D RAS mutations.
- RMC-5127: Selective for G12V RAS mutations.
All are currently in clinical development. This role will enable you to join a high-performing team dedicated to advancing cancer treatments for patients with RAS mutation-driven cancers.
About the Role
The Senior Director of Safety Surveillance is a strategic, executive-level leader responsible for designing, maintaining, and optimising Global Patient Safety (GPS) processes at Revolution Medicines. This key role oversees safety surveillance, pharmacovigilance (PV), and regulatory compliance across all development stages while fostering a culture of safety excellence and continuous improvement.
As a SME in safety science and regulatory strategy, you will: -Drive safety innovation, ensuring alignment with workplace culture and patient needs. -Collaborate with cross-functional teams (Development, Regulatory Affairs, Clinical Operations) to implement risk-based safety measures. -Leverage advanced analytics and technological tools to enhance PV processes.
Responsibilities
Leadership & Governance
- Provide effective team leadership, mentorship, and accountability for an experienced global safety team, ensuring compliance with internal values and external regulatory standards.
- Manage GPS team resources, prioritise projects, and drive process improvements to strengthen pharmacovigilance system quality (GVP, GCP, GDocP).
- Develop and maintain a robust PV quality system, ensuring inspection readiness and acting as a Subject Matter Expert (SME) for audits and regulatory inspections.
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Process Design & Compliance
- Partner with cross-functional business units to revise and enhance safety processes, including:
- Risk Management Plans (RMPs)
- Developmental Safety Update Reports (DSURs)
- Periodic Safety Update Reports (PSURs)
- Aggregate reporting strategies
- Provide scientific consultation to regulatory filing teams, including:
- Integration of safety content into protocol development, Informed Consent Forms (ICFs), and Investigator Brochures (IBs).
- Support for NDA/BLA/MAA filing packages (e.g., ISI/ISE narratives, Clinical Summary, Label changes).
Regulatory & External Engagement
- Maintain expert knowledge of evolving regulatory landscapes (ICH, FDA, EMA guidelines) and proactive mitigation strategies.
- Collaborate with the EU QPPV to ensure European compliance.
- Ensure smooth interactions with regulatory authorities, including type C/B/pre-BLA/MAA meetings and Scientific Advice forums.
Innovation & Continuous Improvement
- Develop bespoke safety solutions to address emerging regulatory and clinical challenges.
- Drive knowledge sharing and good practice innovation across the organisation.
- Partner with systems teams to implement efficient PV technologies that support scale and compliance.
- Be a Strategic Viewer: Anticipate and influence Volkswagen employees to meet evolving needs while maintaining patient safety.
Team Development & Collaboration
- Mentor and develop talent within the GPS team, fostering a culture of safety, compliance, and collaboration.
- Lead training initiatives to ensure team readiness for global inspections.
- Build partnerships with external and internal stakeholders (development partners, investigators).
Required Skills, Experience & Education
Professional Experience
- Minimum of 12 years in pharmacovigilance (PV) or a related field, with at least 6 years of people management (Clear evidence of leadership in complex, cross-functional pharmaceutical disciplines).
- Proven regulatory advisory experience: Experience conducting meetings with FDA, EMA, or other agencies.
- Advanced safety and clinical expertise, including in ** label development and risk management**.
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Education
- Advanced degree in Medicine (MD), Pharmacology (PharmD), or related field (PhD/MSc level) or equivalent postgraduate qualification.
- Strong ICH, GVP, GCP, and regulatory knowledge with a consistent history of compliance.
Soft Skills & Leadership
- Goal orientation & strategy execution: Ability to balance clinical, safety, and business needs.
- High emotional quotient (EQ): Foster constructive relationships across all levels.
- Stakeholder management: Represent Revolution Medicines securely in cross-functional settings.
Technical & Analytical Expertise
- Familiarity with advanced safety analytics and PV system capabilities.
- Proficiency in Excel, regulatory submission tools, and document management systems.
Preferred Skills (Bonus Consideration)
- Hands-on BLA/MAA filing experience.
- Experience leading PV systems transition/carve-out engagements.
- Experience in licensure or biosimilar development programs.
Company Commitment
Revolution Medicines prioritises the protection and confidentiality of personal data (see our CCPA Notice and Privacy Policy). If you have questions, contact privacy@revmed.com.
⚠️ Security Notice
⌛ Would you believe non-official messages from Revolution Medicines? We would never invade your personal accounts for job applications.
Never provide: V Financial details. Purchase information. Lesson payments.
Top 3 trust signs: ✅ All 公司 email addresses end with “@revmed.com.” ✅ Messages appear sponsored transactions (e.g., LinkedIn). ✅ Not reproduce on work (id.)
Falsified recruitment contends disseminates false information and targets integrity of candidates. Should a situation involving fraud or impersonation, please report to careers@revmed.com
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