Director, Study Quality and Compliance - Nonclinical Safety/Toxicology

Novartis Group Companies; Cambridge (MA); Vor Ort; USD 185.500 - 344.500; Vollzeit

Zusammenfassung

Novartis Group of Companies in Cambridge, MA seeks a Director to oversee the Study Quality and Compliance team within Preclinical Safety. You will drive GLP compliance, manage data for internal and external toxicology studies, and implement software to track study information and analytics.

The role requires an advanced biology degree with extensive pharma experience or a BS with substantial background, leadership skills, and fluency in English.

Qualifikationen

• Advanced degree or extensive experience in pharmaceutical biology and toxicology.
• Experience working with GLP guidelines and toxicology studies.
• Experience leading teams and projects.
• Excellent written and spoken English communication.
• Strong leadership and organizational abilities.

Aufgaben

• Oversee the Study Quality and Compliance team and set long‑term strategy.
• Lead implementation of tracking and analytics software across the toxicology function.
• Manage toxicology study data and prepare data warehouse availability.
• Ensure SEND datasets are high quality and regulatory-ready.
• Oversee SOPs and training records for GLP compliance and archives interfacing.
• Support biomarker data transfer and diligence activities involving SEND data.

Kenntnisse

Animal Models

Bioinformatics

Collaboration

Communication Skills

Data Analysis

Decision Making

Ethics

Leadership

Management

Mentorship

Problem Solving

Regulatory Compliance

Researching

Risk Assessments

Toxicology

Ausbildung

Advanced degree in biological-related sciences

BS degree in biological-related sciences

Jobbeschreibung

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 Preclinical Safety (PCS). The team is responsible for handling samples and data associated with both internally and externally conducted toxicology studies; maintaining departmental SOPs; and overseeing training records for departmental personnel. The team also interfaces with the archives function to ensure proper storage of toxicology‑related materials.

A major part of this role is to identify and implement a software system that enables effective tracking and analytics of study‑related information overseen by the group.

Key Responsibilities

• Lead and provide strategic oversight to the PCS Study Quality and Compliance team, establishing long‑term strategy and yearly goals.
• Modernize group functionality by leading the implementation of tracking, management, and data analytics software (e.g., Smartsheet) across the toxicology line function.
• Oversee toxicology study data management for external and internal studies, ensuring suitability and availability for the internal toxicology study data warehouse.
• Ensure SEND (Standard for Exchange of Nonclinical Data) datasets are of high quality and ready in a timely manner for regulatory submissions, including datasets from external CROs and de‑novo generation for internal non‑GLP studies.
• Oversee 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.
• Support biomarker and pathology with respect to shipment of study samples and digital slide data transfer.
• Support diligence acquisition and licensing deals through oversight and management of study‑related data (including SEND) requiring transfer.

Essential Requirements

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

Desirable Requirements

• Experience with software tools for data and/or program management.
• Experience with SEND, or at least general familiarity with its requirements.

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 relevant skills and experience and will be reviewed periodically upon joining Novartis. Compensation includes a performance‑based cash incentive and, depending on the role level, eligibility for annual equity awards.

US‑based eligible employees receive a comprehensive benefits package, including health, life and disability benefits, a 401(k) with company contribution and match, and various other benefits. Employees also receive a generous time‑off package, including vacation, personal days, holidays, and other leaves.

EEO Statement

The Novartis Group of Companies is an Equal Opportunity Employer. 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.

Skills Desired

• Animal Models
• Bioinformatics
• Collaboration
• Communication Skills
• Data Analysis
• Decision Making
• Ethics
• Leadership
• Management
• Mentorship
• Problem Solving
• Regulatory Compliance
• Researching
• Risk Assessments
• Toxicology