Associate Director, Pathology

Asklepios BioPharmaceutical, Inc. (AskBio)•Durham, NC

92d

About The Position

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. Our vision: Pioneering science to create transformative molecular medicines. Our mission: Lead innovative science and drive clinical outcomes to transform people's lives. Our principles: Advance innovative science by pushing boundaries. Bring transformative therapeutics to patients in need. Provide an environment for employees to reach their fullest potential. Our values: Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need. Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view. Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers. Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action. Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through. Position Summary The Associate 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 AD, 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.

Requirements

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

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