Director, Study Quality and Compliance – Nonclinical Safety/Toxicology

Overview

In this role you will lead the Study Quality and Compliance group within Preclinical Safety, shaping strategy and the annual plan. You will drive modernization of tracking and data analytics across the toxicology function, ensuring high-quality SEND data and GLP compliance for both internal and external studies. You will partner with archives, training, and biomarker teams to support data transfer and study readiness, enabling timely regulatory submissions and operational excellence. Join a mission-driven environment where quality, data, and cross-functional collaboration propel safer medicines.

Pay / Benefits

• comprehensive benefits package
• health, life and disability benefits
• 401(k) with company contribution and match
• performance-based cash incentive
• eligibility for annual equity awards
• generous time off package

Responsibilities

• Provide strategic leadership for the Study Quality and Compliance team and set long-term goals
• Lead modernization and rollout of tracking, management, and data analytics software across toxicology (e.g., Smartsheet)
• Oversee toxicology study data management from internal and external studies for the data warehouse
• Ensure high-quality SEND datasets and timely readiness for regulatory submissions (external CRO and internal non-GLP)
• Oversee SOPs and training records to ensure GLP compliance and interface with Archive Records Management
• Support sample shipment and data transfer for biomarker and pathology studies
• Assist diligence, acquisitions, and licensing data transfer related to study data (including SEND)

Key requirements

• Advanced degree in biological-related sciences or BS with 15 years of pharmaceutical experience
• Experience with GLP guidelines and pharmaceutical toxicology studies
• Prior people management or leadership experience
• Strong communication and logistical/planning skills
• Fluent in English (spoken and written)

• Strong communication
• Leadership
• Collaboration
• Data management and analytics
• Experience with regulatory data (SEND)
• Use of data management software (eg, Smartsheet)

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