Director, Study Quality and Compliance - Nonclinical Safety/Toxicology

Novartis AG; Cambridge (MA); Hybrid; USD 186,000 - 345,000; Full time

Benefits offered by this job

Health, life and disability benefits

401(k) with company match

Generous vacation and time-off

Job summary

Novartis AG in Cambridge, MA seeks a Director to lead the PCS Study Quality and Compliance team, driving long-term strategy and yearly goals. The role focuses on GLP-compliant toxicology studies, data management, and readiness of SEND datasets for regulatory submissions.

The position requires extensive toxicology experience, strong leadership, and fluency in English. It is a hybrid role with responsibilities spanning data systems, training, and cross-functional collaboration.

Qualifications

• PhD/advanced degree in biology-related sciences with extensive toxicology experience preferred.
• GLP guidelines knowledge and toxicology study oversight.
• Familiarity with SEND or related data requirements.

Responsibilities

• Lead and provide strategic oversight to the PCS Study Quality and Compliance team.
• Modernize group functionality with tracking, management, and data analytics software across toxicology.
• Oversee toxicology study data management and prepare data for internal data warehouse.

Skills

Leadership

Communication

Data Analysis

Problem Solving

Ethics

Mentorship

Education

Advanced degree in biology-related sciences

BS in biology-related sciences

25+ years of relevant industry experience

Tools

Smartsheet

Job description

Job Description Summary

Location: Cambridge MA

Internal: Director

LI#-Hybrid

Job Description

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

Essential Requirements:

• Advanced degree in biological-related sciences with at least 10 years of relevant pharmaceutical experience, BS degree in biological-related science with at least 15 years of experience, or 25+ years of relevant industry experience in oversight and compliance of toxicology studies.


• Previous experience working with GLP guidelines and pharmaceutical toxicology studies, and associated quality, compliance, and animal welfare attributes


• 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


• Good communication skills, and excellent logistical/planning skills


• Fluent in English (spoken and written)

Salary

• The salary for this position is expected to range between: $185,500 and $344,500 per year.


• The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

Benefits

• US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits.


• In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

Click here link

To learn more about the culture, rewards and benefits we offer our people click here .

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

• $185,500.00 - $344,500.00

Skills Desired

• Animal Models


• Bioinformatics


• Collaboration


• Communication


• Data Analysis


• Decision Making


• Ethics


• Laboratory Research


• Leadership


• Management Techniques


• Mentorship


• Problem Solving


• Regulatory Compliance


• Researching


• Risk Assessments


• Toxicology


• Training and Development


• Waterfall Model