Associate Director, Global Patient Safety, Systems & Analytics
About The Position
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s 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 Revolutionaries in 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 RevMed’s global pharmacovigilance operations. This role provides discipline‑level 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, inspection‑ready, and aligned with RevMed’s evolving portfolio and regulatory obligations. The Associate Director leads cross‑functional initiatives, oversees system enhancements and integrations, and ensures that GPS has the technology and data foundation required to support high‑quality 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:
Requirements
- Bachelor’s degree in a scientific, technical, or related field required.
- At least 11 years of experience with Bachelor’s (9 years with Master’s) in pharmacovigilance systems, safety operations, or related technical domains.
- Demonstrated leadership experience managing complex system implementations, upgrades, or integrations.
- Hands‑on 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).
- Strategic thinker with the ability to translate complex technical concepts into operational solutions.
- Strong analytical and problem‑solving skills, with the ability to interpret complex safety data.
- Excellent communication skills with both technical and non‑technical stakeholders.
- Demonstrated ability to lead cross‑functional initiatives and drive alignment across diverse teams.
- Commitment to quality, compliance, and operational excellence.
- Ability to manage multiple priorities in a fast‑paced, evolving environment.
- Proven ability to mentor and develop team members, fostering a collaborative and high‑performance culture.
Nice To Haves
- Advanced degree preferred.
Responsibilities
- Provide day‑to‑day leadership and direction to team members within Systems & Analytics, ensuring clarity of priorities, alignment to departmental goals, and consistent delivery of high‑quality work.
- through regular feedback, performance discussions, and growth‑oriented development plans.
- Set clear expectations for technical excellence, documentation quality, and operational rigor across all system and data activities.
- Foster a collaborative, inclusive, and high‑performance 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 cross‑functional forums, representing the Systems & Analytics discipline and ensuring alignment with Safety Operations, Safety Science, IT, and Quality.
- Ensure team members maintain inspection‑ready documentation, follow validated processes, and adhere to GxP and data‑integrity expectations.
- Guide staff through complex problem‑solving, helping them navigate ambiguity, assess risk, and make sound decisions.
- Model RevMed’s values and leadership behaviors, reinforcing a culture of quality, compliance, and operational excellence.
- 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 change‑control processes, audit‑ready documentation, and validated workflows.
- Anticipate system needs driven by portfolio growth, regulatory changes, and operational trends.
- 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 decision‑making across GPS.
- Establish data‑quality monitoring frameworks and lead cross‑functional efforts to resolve discrepancies and improve upstream data integrity.
- Ensure analytics outputs meet regulatory expectations for completeness, reproducibility, and inspection readiness.
- Serve as a primary technical and strategic partner to Safety Operations, Safety Science, Regulatory, and Clinical teams.
- Lead cross‑functional initiatives involving system enhancements, integrations, and process modernization.
- Drive continuous improvement through automation, workflow optimization, and innovative technology solutions.
- Ensure GPS users receive role‑based training, clear documentation, and ongoing support for system functionality and best practices.
- Support vendor oversight, including issue resolution, enhancement prioritization, and release planning.
- Ensure all safety systems and processes comply with global regulatory requirements (FDA, EMA, PMDA, MHRA, ICH).
- Maintain audit‑ready documentation for system configuration, validation, testing, and data‑quality 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, data‑integrity standards, and internal quality requirements.
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What This Job Offers
Job Type
Full-time
Career Level
Director
