We are a gene therapy company changing lives with every genetic advancement.
Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that cure genetic diseases has never wavered.
As the only end-to-end gene therapy company in the industry, we’ve built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease and congestive heart failure. Our gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library.
We became a wholly owned, independently operated subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy Platform. Our global headquarters are in Research Triangle Park, North Carolina, a thriving biotechnology hub, and we maintain additional research and development operations in Scotland and France and gene therapy manufacturing in Spain.
We have an opportunity for a Sr. Toxicologist/Pharmacologist to join the AskBio team in our Research Triangle Park (Durham), NC location and be part of our continued success!
About the role
We are seeking a Sr. Toxicologist/Pharmacologist (Scientist 2-3). This role will provide scientific guidance and leadership in the preclinical safety de-risking of AAV-based gene therapies and work in close collaboration with colleagues in Translational Medicine.
Responsibilities & accountabilities
- Key member on multidisciplinary project teams to represent the toxicology function to define and implement nonclinical safety evaluation strategy and plan of novel candidate molecules
- Participate in research project teams to lead the evaluation of potential safety and toxicity liabilities of biologic pathways of interest
- Lead the design and conduct of experiments to help inform the potential translatability and relevance of nonclinical safety findings to humans
- Design and interpret PK/TK models
- Responsible for drafting and reviewing nonclinical sections of regulatory documents (IND, IMPD, IB, briefing packages) including nonclinical pharmacology and toxicology
- Manage toxicology studies in-house and at contract research organizations (CROs)
- Perform the role of Study Monitor and/or provide support for nonclinical toxicology studies, primarily in the framework of studies conducted globally by CROs
- Participate in the selection and qualification of applicable CROs and manage the logistics of study initiation and conduct, including protocol development, attention to budget management/tracking, ongoing oversight and review and data and final report
- Between 2-6+ years of experience in the biotech/pharmaceutical industry in the area of nonclinical drug discovery and/or development
- PhD degree with 2-5+ years of experience or MS degree with 3-6+ years of experience in toxicology, pathology, pharmacology, or related discipline
- Understanding of pharmacokinetic/pharmacodynamic models
- Excellent interpersonal skills and ability to work in a matrixed environment and develop relationships with key stakeholders
- Excellent communication and presentation skills to efficiently relay information to project teams and other key stakeholders
- Experience with AAV, cell and gene therapies, drug discovery and development desired, but not required
- Proven ability to work independently and be self-motivated
Live an AskLife™
We offer a competitive total rewards package. Are you our next great discovery?