Associate Director, Global Patient Safety, Systems & Analytics

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys R&D pipeline comprises RAS(ON) Inhibitors designed 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 outstanding Revolutionariesin a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

We are seeking an experienced and strategic safety systems leader to join our Global Patient Safety (GPS) department. The Associate Director Systems & Analytics plays a critical leadership role in shaping governing and advancing the technology data and analytics capabilities that underpin RevMeds global pharmacovigilance operations.

This role provides disciplinelevel leadership across safety systems data pipelines analytics products and operational governance. The Associate Director partners closely with Safety Operations Safety Science IT Quality and external vendors to ensure that GPS systems are scalable compliant inspectionready and aligned with RevMeds evolving portfolio and regulatory obligations.

The Associate Director leads crossfunctional initiatives oversees system enhancements and integrations and ensures that GPS has the technology and data foundation required to support highquality case processing signal detection and regulatory reporting.

The successful candidate will be a strategic collaborative and technically strong leader who brings deep expertise in pharmacovigilance systems and data. The candidate will meet the following requirements:

Management & Leadership Responsibilities

• Provide daytoday leadership and direction to team members within Systems & Analytics ensuring clarity of priorities alignment to departmental goals and consistent delivery of highquality work.

• through regular feedback performance discussions and growthoriented development plans.

• Set clear expectations for technical excellence documentation quality and operational rigor across all system and data activities.

• Foster a collaborative inclusive and highperformance team culture encouraging innovation accountability and continuous improvement.

• Oversee workload planning resource allocation and prioritization ensuring the team can meet operational demands and strategic initiatives.

• Support recruitment onboarding and training of new team members to build a strong and scalable Systems & Analytics function.

• Provide leadership presence in crossfunctional forums representing the Systems & Analytics discipline and ensuring alignment with Safety Operations Safety Science IT and Quality.

• Ensure team members maintain inspectionready documentation follow validated processes and adhere to GxP and dataintegrity expectations.

• Guide staff through complex problemsolving helping them navigate ambiguity assess risk and make sound decisions.

• Model RevMeds values and leadership behaviors reinforcing a culture of quality compliance and operational excellence.

Systems Leadership & Governance

• Provide strategic direction for GPS systems ensuring alignment with departmental and enterprise priorities.

• Lead the roadmap governance and lifecycle management of core safety platforms including Safety One Argus Safety One Intake and analytics tools.

• Oversee system configuration validation and release management ensuring compliance with global regulatory expectations.

• Partner with IT and Quality to maintain robust changecontrol processes auditready documentation and validated workflows.

• Anticipate system needs driven by portfolio growth regulatory changes and operational trends.

Data Quality Analytics & Reporting

• Oversee the design and maintenance of safety data outputs ensuring accuracy completeness and traceability.

• Guide the development of analytics dashboards operational metrics and signal detection tools to support decisionmaking across GPS.

• Establish dataquality monitoring frameworks and lead crossfunctional efforts to resolve discrepancies and improve upstream data integrity.

• Ensure analytics outputs meet regulatory expectations for completeness reproducibility and inspection readiness.

Operational Excellence & CrossFunctional Collaboration

• Serve as a primary technical and strategic partner to Safety Operations Safety Science Regulatory and Clinical teams.

• Lead crossfunctional initiatives involving system enhancements integrations and process modernization.

• Drive continuous improvement through automation workflow optimization and innovative technology solutions.

• Ensure GPS users receive rolebased training clear documentation and ongoing support for system functionality and best practices.

• Support vendor oversight including issue resolution enhancement prioritization and release planning.

Compliance & Inspection Readiness

• Ensure all safety systems and processes comply with global regulatory requirements (FDA EMA PMDA MHRA ICH).

• Maintain auditready documentation for system configuration validation testing and dataquality activities.

• Lead preparation for global inspections and audits including system demonstrations data outputs and technical responses.

• Ensure GPS systems and analytics capabilities meet GxP expectations dataintegrity standards and internal quality requirements.

Required Skills Experience and Education:

• Bachelors degree in a scientific technical or related field required.

• At least 11 years of experience with Bachelors (9 years with Masters) in pharmacovigilance systems safety operations or related technical domains.

• Demonstrated leadership experience managing complex system implementations upgrades or integrations.

• Handson expertise with safety databases and analytics platforms (e.g. Safety One Argus Empirica Signal Spotfire Oracle Analytics Server).

• Strong understanding of pharmacovigilance processes including case processing ICSR and aggregate reporting and electronic data exchanges.

• Experience supporting regulatory inspections and audits including preparation of system evidence and technical documentation.

• Proficiency with data tools such as SQL Spotfire Python or equivalent.

• Deep knowledge of global pharmacovigilance regulations and guidelines (FDA EMA ICH PMDA).

Core Competencies

• Strategic thinker with the ability to translate complex technical concepts into operational solutions.

• Strong analytical and problemsolving skills with the ability to interpret complex safety data.

• Excellent communication skills with both technical and nontechnical stakeholders.

• Demonstrated ability to lead crossfunctional initiatives and drive alignment across diverse teams.

• Commitment to quality compliance and operational excellence.

• Ability to manage multiple priorities in a fastpaced evolving environment.

• Proven ability to mentor and develop team members fostering a collaborative and highperformance culture.

Preferred Skills:

• Advanced degree preferred.

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