Director, Study Quality and Compliance - Nonclinical Safety/Toxicology
Novartis
August 21, 2026
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Key Responsibilities:
- Lead and provide strategic oversight to the PCS Study Quality and Compliance team; set long-term strategy and yearly goals.
- Modernize group functionality by implementing tracking, management, and data analytics software (e.g., Smartsheet) across the toxicology line.
- Oversee toxicology study data management (external and internal), including data suitability and availability for the internal toxicology study data warehouse.
- Ensure SEND (Standard for Exchange of Nonclinical data) datasets are high-quality and ready for timely regulatory submissions (including external CRO SEND and de novo generation for internal non-GLP studies).
- Oversee SOPs and training records to ensure GLP compliance; interface with Archive Records Management.
- Support biomarker and pathology logistics (shipment of study samples and digital slide data transfer).
- Support diligence acquisition and licensing deals by overseeing transfer of study-related data (including SEND).
Essential Requirements:
- Advanced degree in biological-related sciences with 10+ years relevant pharmaceutical experience, or BS with 15+ years.
- Experience with GLP guidelines and pharmaceutical toxicology studies (quality, compliance, animal welfare).
- Prior people management/leadership experience.
- Excellent communication and logistical/planning skills.
- Fluent in English (spoken and written).
Desirable Requirements:
- Experience with software tools for data/program management.
- Prior SEND experience or strong familiarity with SEND requirements.
Compensation & Benefits:
- Salary range: $185,500–$344,500/year; performance-based incentive; potential annual equity awards.
- US-based eligible employees: comprehensive health/life/disability, 401(k) with match, and paid time off.
- Lead and provide strategic oversight to the PCS Study Quality and Compliance team; set long-term strategy and yearly goals.
- Modernize group functionality by implementing tracking, management, and data analytics software (e.g., Smartsheet) across the toxicology line.
- Oversee toxicology study data management (external and internal), including data suitability and availability for the internal toxicology study data warehouse.
- Ensure SEND (Standard for Exchange of Nonclinical data) datasets are high-quality and ready for timely regulatory submissions (including external CRO SEND and de novo generation for internal non-GLP studies).
- Oversee SOPs and training records to ensure GLP compliance; interface with Archive Records Management.
- Support biomarker and pathology logistics (shipment of study samples and digital slide data transfer).
- Support diligence acquisition and licensing deals by overseeing transfer of study-related data (including SEND).
Essential Requirements:
- Advanced degree in biological-related sciences with 10+ years relevant pharmaceutical experience, or BS with 15+ years.
- Experience with GLP guidelines and pharmaceutical toxicology studies (quality, compliance, animal welfare).
- Prior people management/leadership experience.
- Excellent communication and logistical/planning skills.
- Fluent in English (spoken and written).
Desirable Requirements:
- Experience with software tools for data/program management.
- Prior SEND experience or strong familiarity with SEND requirements.
Compensation & Benefits:
- Salary range: $185,500–$344,500/year; performance-based incentive; potential annual equity awards.
- US-based eligible employees: comprehensive health/life/disability, 401(k) with match, and paid time off.