Director, Study Quality and Compliance - Nonclinical Safety/Toxicology

Novartis • Cambridge, MA

9d • $185,500 - $344,500 • Hybrid

About The Position

This role oversees the Study Quality and Compliance team within the Toxicology line function of Preclinical Safety (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.

Requirements

• Advanced degree in biological-related sciences with at least 10 years of relevant pharmaceutical experience, or BS degree in biological-related science with 15 years of experience
• Previous experience working with GLP guidelines and pharmaceutical toxicology studies, and associated quality, compliance, and animal welfare attributes
• Previous people management or leadership experience
• Good communication skills, and excellent logistical/planning skills
• Fluent in English (spoken and written)

Nice To Haves

• Previous experience with software tools for data and/or program management is highly desired
• Previous experience with SEND, or at a minimum good general familiarity with its requirements is desired

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 (Standard for Exchange of Nonclinical data) 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

Benefits

• health, life and disability benefits
• a 401(k) with company contribution and match
• a variety of other benefits
• a generous time off package including vacation, personal days, holidays and other leaves

What This Job Offers

• Job Type: Full-time
• Career Level: Director