AskBio Inc. · 10 hours ago
Associate Director, Pathology
Durham, NC
Full-time
Onsite
Lead/Staff, Director/Executive
8+ years expAskBio Inc. is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The Associate Director of Pathology will lead Translational Medicine Safety for multiple drug candidates, ensuring high-quality toxicology and pathology assessments while guiding study designs and regulatory submissions.
BiopharmaBiotechnologyHealth CareManufacturingMedicalMedical Device
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
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 histopathology group
Other pathology and translational medicine-related tasks as assigned
Qualification
Required
PhD or DVM with 8+ years of post-graduate experience in a pharmaceutical, biotech or academic organization
Board certification by the American College or European College of Veterinary Pathologists (ACVP or ECVP certification) in Anatomic Pathology
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
Company
AskBio Inc.
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.
501-1000 employees
H1B Sponsorship
AskBio Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (4)
2022 (8)
2021 (3)
2020 (3)
Funding
Current Stage
Late StageTotal Funding
$241.76MKey Investors
Scottish Enterprise
2020-10-26Acquired
2020-09-02Grant· $2.66M
2019-04-11Private Equity· $235M
Leadership Team
S
Samuel Hopkins
Sr. Vice President, Therapeutics
Mansuo L Shannon
Board Member
Recent News
Asklepios BioPharmaceutical, Inc. (AskBio)
2025-10-21
Company data provided by crunchbase