Director, Study Quality and Compliance - Nonclinical Safety/Toxicology
About The Position
The Director oversees the Study Quality and Compliance team within the Toxicology line function of PCS. The team handles samples and data associated with internally and externally conducted toxicology studies, maintains departmental SOPs, oversees departmental personnel training records, and works with the archives function to ensure proper storage of toxicology-related materials and records. A major focus is identifying and implementing software to track and analyze study-related information overseen by the group. The role provides strategic leadership for the team, sets long-term strategy and annual goals, and modernizes its functionality through tracking, management, and analytics software across the toxicology line function. It oversees toxicology study data management, including data suitability and availability for the internal toxicology study data warehouse, and ensures high-quality SEND datasets are prepared promptly for regulatory submissions. The Director also oversees SOPs, training records, archive interfaces, support for biomarker and pathology sample shipments and digital-slide data transfers, and study-related data transfers for diligence, acquisition, and licensing deals.
Requirements
- Advanced degree in a biological-related science and at least 10 years of relevant pharmaceutical experience; or a BS degree in a biological-related science and at least 15 years of experience; or 25 or more years of relevant industry experience overseeing and ensuring compliance of toxicology studies.
- Previous experience working with GLP guidelines and pharmaceutical toxicology studies, including associated quality, compliance, and animal welfare attributes.
- Good communication skills and excellent logistical and planning skills.
- Fluency in spoken and written English.
Nice To Haves
- Previous experience with software tools for data and/or program management is highly desired.
- Previous experience with SEND, or at minimum good general familiarity with its requirements, is desired.
Responsibilities
- Lead and provide strategic oversight to the PCS Study Quality and Compliance team, establishing long-term strategy and annual goals.
- Modernize group functionality by leading implementation of tracking, management, and data analytics software across the toxicology line function.
- Oversee toxicology study data management for internal and external studies, including suitability and availability of data for the internal toxicology study data warehouse.
- Ensure SEND datasets are high-quality and ready in a timely manner for regulatory submissions, including datasets from external CROs and datasets generated de novo for internal non-GLP studies.
- Oversee SOPs and training records for PCS personnel to ensure compliance with GLP expectations.
- Serve as the management interface with the Archive Records Management team.
- Oversee support for biomarker and pathology, including shipment of study samples and transfer of digital-slide data.
- Support diligence, acquisition, and licensing deals by overseeing and managing study-related data, including SEND, for transfer.
Benefits
- Comprehensive health, life, and disability benefits.
- 401(k) with company contribution and match.
- A variety of other benefits.
- Generous time-off package including vacation, personal days, holidays, and other leaves.
- Performance-based cash incentive.
- Depending on role level, eligibility to be considered for annual equity awards.
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What This Job Offers
Job Type
Full-time
Career Level
Director
