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 designed to suppress diverse oncogenic variants of RAS proteins, including:
- Darot metastib (RMC-6236), a RAS(ON) multi-selective inhibitor
- Eliron rasib (RMC-6291), a RAS(ON) G12C-selective inhibitor
- Zoldon rasib (RMC-9805), a RAS(ON) G12D-selective inhibitor
- RMC-5127, a RAS(ON) G12V-selective inhibitor (all currently in clinical development)
As a new member of the Revolution Medicines team, you will join a dedicated group of professionals committed to improving outcomes for patients with RAS-mutated cancers.
About the Role
The Senior Director of Safety Surveillance is a senior leadership role within the Patient Safety (PV) team, responsible for overseeing and advancing Global Patient Safety (GPS) processes. This position requires a subject matter expert in safety risk management, signal detection, benefit-risk assessment, and cumulative safety reporting.
In this capacity, you will:
- Develop, maintain, and refine core GPS processes (e.g., Risk Management Plans (RMPs), Developmental Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs)) in compliance with international regulations.
- Provide strategic leadership for a high-performing global team, ensuring alignment with company values and regulatory requirements.
- Collaborate with cross-functional teams to enhance pharmacovigilance (PV) efficiency, quality, and regulatory compliance.
- Serve as a key advisor on safety processes for เภјญญัว and filing teams, including regulatory submissions (NDA/MAA modules).
- Support audit, inspection readiness, and continual improvement initiatives in alignment with Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and regulatory expectations.
- Drive innovation in safety surveillance while ensuring standardised, high-quality outputs across the company’s product portfolio.
Key Responsibilities
Leadership & Team Management
- Direct, mentor, and hold accountable a global team focused on safety process development, ensuring alignment with Revolution Medicines’ values.
- Oversee resource allocation and quality improvements in the PV system to meet GPS priorities.
- Provide strategic direction for GPS and cross-functional Development teams, ensuring adherence to global regulatory standards (e.g., ICH, FDA, EMA).
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Scientific & Regulatory Leadership
- Develop and modify creator documentation for safety processes, including RMPs, DSURs, PSURs, and regulatory submissions (ISS, ISE, safety narratives).
- Support filing strategies for емыеوอี (NDA), MAAs (MAA), and labelling decisions, working closely with Regulatory Affairs.
- Collaborate with the EU Qualified Person Responsible for Pharmacovigilance (QPPV) to ensure European compliance.
- Serve as the SME for audits and inspections, ensuring readiness for global regulatory review.
- Maintain expert-level knowledge of evolving regulatory and legislative changes, aportting this to process refinement.
Process Innovation & Quality Assurance
- Drive quality system development in compliance with GCP and GVP, ensuring transparency, efficiency, and regulatory robustness.
- Anticipate future regulatory challenges and implement adaptive solutions to enhance safety outputs.
- Facilitate cross-functional alignment with policy governance bodies to strengthen safety processes.
- Promote a culture of safety, compliance, and continuous improvement across GPS and the broader organization.
- Implement PV data analytics and system upgrades to improve safety surveillance efficiency.
Cross-Functional & External Stakeholder Relations
- Work with internal/external partners (e.g., Development partners, contractors, CROs) to advance safety and compliance goals.
- Provide subject-matter consulting to Regulatory, Clinical, and filing teams on safety-critical decisions.
- Foster collaborative partnerships with both internal and external stakeholders to promote best practices.
- Ensure clear, consistent, and impactful communication of safety information to all stakeholders.
Required Skills & Experience
Education & Professional Background
- An advanced degree in Medicine, Pharmacy, or related field (e.g., MD, PharmD, PhD/MSc, or equivalent).
- Minimum 12 years of experience in pharmacovigilance (PV) or clinical safety within the pharmaceutical or biotechnology industry.
- Minimum 6 years of people management experience, including mentorship, leadership, and ambiguity tolerance.
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Technical & Professional Competencies
- Proven leadership record in pharmacovigilance with expertise in:
- Signal detection & management
- Risk management strategies (RMPs)
- Benefit-risk assessment
- Regulatory submissions (NDA/MAA filings)
- Extensive experience in interacting with regulatory agencies (e.g., FDA Medicine Advisory Committee meetings, ICH, EMA pre-licensing discussions).
- In-depth knowledge of global PV regulations (ICH E2C, GVP, GFSR) and a strong track record of compliance.
- Strong analytical, strategic, and problem-solving skills, with an ability to influence senior stakeholders.
- Exceptional clinical acumen, emotional intelligence, and interpersonal skills.
- Ability to lead complex cross-functional projects in a matrixed organisation.
Preferred Skills
- Experience with advanced safety data analytics and modern PV technology platforms.
- Project management expertise in managing high-impact regulatory filings (BLA/MAA).
- Demonstrated ability to drive change and optimise processes in dynamic regulatory environments.
- Strong network and track record in knowledge-sharing programs for future safety innovation.
Why Join Revolution Medicines?
- Make a direct impact on patient care for those with RAS-mutated cancers.
- Work at the forefront of oncology innovation, pioneering treatments for lethal cancer variants.
- Thriving environment of collaboration, excellence, and commitment to scientific progress.
Privacy & Security Notice
Revolution Medicines deeply values data privacy. Should you share personal information through our website, social media, or channels, it will be handled in accordance with our CCPA Policy and Privacy Statement.
🚨 Note on Recruitment Scams: We will never make unsolicited hiring offers nor ask for fees, financial details, or equipment purchases. If in doubt, contact careers@revmed.com.
For further details, please visit our careers page.
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