Director, Pathology

askbio; Durham (NC); On-site; USD 180,000 - 250,000; Full time

Job summary

AskBio Inc. seeks a Director of Pathology to lead Translational Medicine Safety (anatomic and clinical pathology & toxicology) across multiple drug candidates.

You will act as PI for non‑GLP and GLP studies, ensuring high‑quality pathology assessments to support regulatory submissions (IND/CTA/NDA) and cross‑functional dissemination of findings. The role requires deep expertise in nonclinical safety, histopathology, and regulatory biology, with leadership across Discovery, Product Development,

Qualifications

• DVM with 6+ years of post‑graduate experience in pharma/biotech/academia.
• Board certification in Veterinary Pathology (DACVP or ECVP) required or equivalent.
• Experience integrating pathology data into clinical development decisions.
• Familiarity with regulatory submissions (IND/CTA/NDA) and tox/pathology reporting.
• Strong leadership and cross‑functional collaboration skills.

Responsibilities

• Lead Translational Medicine Safety (pathology & toxicology) strategy for nonclinical programs.
• Provide pathology support including histopathology reviews and data interpretation.
• Serve as Principal Investigator for non-GLP and GLP studies and coordinate CROs.
• Guide study design, execution, and reporting for regulatory submissions.
• Mentor and manage histopathology staff and collaborators; drive SOPs and quality.
• Communicate regulatory findings clearly to internal teams and Health Authorities.

Skills

Project management

Regulatory knowledge

Nonclinical safety assessment

Leadership

Written communication

Education

DVM

Board Certification in Veterinary Pathology (DACVP/ECVP)

Master’s or PhD in a scientific discipline

Tools

LIMS

Digital/pathology imaging (H&E/IHC)

Job description

AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life‑saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical‑stage pipeline that includes investigational therapeutics for congestive heart failure, limb‑girdle muscular dystrophy, multiple system atrophy, Parkinson’s disease, and Pompe disease. AskBio’s gene therapy platform includes Pro10™, an industry‑leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre‑clinical and clinical testing.

Position Summary

The Director Pathology serves as the lead for Translational Medicine Safety (anatomic and clinical pathology & toxicology) of multiple drug candidates of AskBio’s pipeline and reports to the Sr. Director, Pathology. This individual will act as the Principal Investigator for pathology components of non‑GLP and GLP‑compliant studies to ensure high‑quality toxicology and pathology assessments. The Director, Pathology will 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.). Additionally, they will frequently interact with internal and external colleagues to ensure timely and accurate dissemination of findings. The successful candidate will demonstrate excellent communication and leadership skills, with the ability to translate complex scientific findings into actionable insights for cross‑functional teams.

Job Responsibilities

• Serve as the lead for Translational Medicine (anatomic and clinical pathology & toxicology), shaping the strategy and execution of nonclinical safety assessments
• 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, Product Development, Clinical Development, and Regulatory to integrate nonclinical safety findings into overall program strategy and goals
• Advise and direct the preparation of Toxicology sections of regulatory documents (IND, CTA, NDA, briefing books, Investigator Brochures, etc.)
• Represent Translational Medicine on discovery and development‑IPT and EPT program teams
• Oversee and drive 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
• Participate in selecting, developing and evaluating personnel to ensure efficient operation within the histopathology group
• Other pathology and translational medicine‑related tasks as assigned

Minimum Requirements

• DVM with 6+ years of post‑graduate experience in a pharmaceutical, biotech or academic organization
• Board certification in Veterinary Pathology (DACVP or ECVP)
• Previous experience working on programs that integrate pathological results to drive clinical development
• Experience with LIMS, digital/computational pathology platforms to characterize features from H&E and IHC images
• Expert knowledge in nonclinical safety assessment in drug development of small molecules, biologics, and peptides. Knowledge in gene therapy is plus
• Proven project management skills with the ability to manage multiple projects and priorities simultaneously
• Excellent communication skills (both oral and written) and collaboration skills with the ability to work effectively in a fast paced cross‑functional team environment
• 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

Preferred Education, Experience and Skills

• Master’s or PhD in a scientific discipline

AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‑related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561‑6210 or sending us an email at [e-mail].