Sr. Scientific Director, Toxicologic Pathology
About The Position
About the Role: Act as the Principal Investigator for pathology components of non-GLP and GLP-compliant studies to ensure high-quality toxicology and pathology assessments. Provide comprehensive support for nonclinical studies, including primary histopathology and pathology peer reviews, interpretation of all nonclinical study data/findings, and guiding study designs, execution, and reporting to support regulatory submissions (IND, CTA, NDA, briefing books, Investigator Brochures, etc.). Represents Preclinical development on discovery and development teams and regularly interfaces with internal and external colleagues to ensure timely and accurate dissemination of Safety Pharmacology and Toxicology findings. Demonstrate excellent communication and leadership skills, with the ability to translate complex scientific findings into actionable insights for cross-functional teams.
Requirements
- DVM or PhD and 10+ years of industry experience in toxicologic pathology within biotech or pharmaceutical settings
- Board Certification by the American College of Veterinary Pathologists (ACVP) is required
- Expert knowledge in nonclinical safety assessment in drug development of small molecules, biologics, and peptides.
- Knowledge in gene therapy is plus
- Strong experience of designing, overseeing, and interpreting GLP and non-GLP toxicology studies
- Demonstrate ability to lead and manage internal team members, consultants, and CRO partnerships
- Deep understanding of regulatory requirements for nonclinical safety assessments, including experience with FDA, EMA, and other global health authorities
- Experience in responding to regulatory questions including discussion documents for various Health Authorities in support of discovery and development programs
- Expertise with the design and management of safety pharmacology and toxicology studies (GLP and non-GLP) supporting nonclinical and clinical development programs
- Excellent communication and leadership skills, with the ability to translate complex scientific findings into actionable insights for cross-functional teams
- Proven ability to thrive in a fast-paced, biotech environment
Responsibilities
- Serve as the lead for Nonclinical Safety (anatomic and clinical pathology & toxicology), shaping the strategy and execution of nonclinical safety assessments for NBI's pipeline
- Provide comprehensive support for nonclinical studies, including but not limited to pathology peer reviews, interpretation of all nonclinical study data/findings, and guiding study designs, execution, and reporting to support regulatory submissions
- Act as the Principal Investigator for pathology components of non-GLP and GLP-compliant studies and communicate effectively with CRO pathologists to discuss findings, address questions, and reach the pathology conclusions to ensure high-quality toxicology and pathology assessments
- Manage and provide scientific leadership to the internal staff and work closely with Discovery, Preclinical and Clinical Pharmacology (PCCP), Clinical Development, and Regulatory to integrate nonclinical safety findings into overall program strategy and goals
- Advises and directs the preparation of Safety Pharmacology and Toxicology sections of regulatory documents (IND, CTA, NDA, briefing books, Investigator Brochures, etc.)
- Represent Preclinical Development on discovery and development-stage program teams
- Oversees and drives the preparation of SOPs as needed to guide functional activities and ensures adherence to all Toxicology and Pathology SOPs
- Maintain current knowledge of regulatory guidance, industry standards and recommendations
- Participates in selecting, developing and evaluating personnel to ensure efficient operation within the toxicology group
- Other pathology-related tasks as assigned
Benefits
- retirement savings plan (with company match)
- paid vacation, holiday and personal days
- paid caregiver/parental and medical leave
- health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
Number of Employees
1,001-5,000 employees
