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
- 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
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
