Director, Study Quality and Compliance - Nonclinical Safety/Toxicology

Location: Cambridge (USA)

Job Description Summary

Location: Cambridge MA

Internal: Director

LI#-Hybrid

This role oversees the Study Quality and Compliance team within the Toxicology line function of PCS. This team is responsible for: handling samples and data associated with both internally and externally conducted toxicology studies; maintaining departmental SOPs, and oversight of training records for departmental personnel; and interfacing with the archives function to ensure proper storage of toxicology-related materials and records. A major part of this role will be to identify and implement a software system that enables effective tracking and analytics of study-related information that this group is responsible for overseeing.

Key Responsibilities

Lead and provide strategic oversight to the PCS Study Quality and Compliance team including responsibility for establishing long-term strategy and yearly goals which support it

Modernize the group functionality leading the implementation of tracking, management, and data analytics software (eg, Smartsheet) across the toxicology line function to enhance quality and compliance oversight of toxicology studies

Oversight of toxicology study data management from external and internal studies; this includes data suitability and availability for our internal toxicology study data warehouse

Oversight and responsibility for ensuring SEND datasets are of high-quality and are ready in a timely manner for regulatory submissions, which includes SEND datasets from external CRO and de novo generation for internal non-GLP studies

Oversight of SOPs and training records for PCS personnel to ensure compliance with GLP expectations, and serve as the management interface with the Archive Records Management team

Oversight of support for biomarker and pathology with respect to shipment of study samples and data transfer of digital slides

Support diligence acquisition and licensing deals through oversight and management of study-related data (including SEND) that need to be transferred