We are looking for a Director of Toxicology with an extensive pharmacology/toxicology background and expertise regarding the development of small molecules, biologics, and gene therapy. The successful candidate will provide scientific leadership and play a pivotal role from late-stage research through nonclinical development for all phases of the drug development process including market application and commercialization.
Contribute to and implement an overall drug development strategy to support nonclinical and clinical pharmacology development during all stages of drug development
Work closely with collaborators on animal models of disease including an in-depth understanding of disease etiology
Be able to serve as a nonclinical consult in tumor development based on the molecular biology of genetic alteration(s) following gene therapy (or other modalities) treatments
Help Design, implement, report and interpret nonclinical study data of gene therapy, small molecule, oligonucleotides, biologic or other novel drug candidate constructs across all stages of development
Prepare study synopses, protocols, study reports and regulatory documents to support nonclinical development of the company's drug candidates
Interact/collaborate with various company functions, CROs, university or analytical laboratories, business partners, as necessary to ensure appropriate/timely progression of company projects
Effectively communicate nonclinical findings and their relevance to senior management, project teams, collaborators, and regulatory agencies
Participate in multi-disciplinary drug development teams including lead sub-teams and serving as a program representative at cross functional program meetings
Excellent written and verbal communication skills
Ability to build/foster productive cross-functional collaborations both within and external to the company.
Nonclinical pharmacology with molecular biology/genetics background and with 8+ years of experience in the pharmaceutical, CRO, and/or biotechnology field at a Scientist level.
Expertise in in vivo pharmacology or experience with animal models of disease
Strong understanding of drug development and regulatory process, as well as a good understanding of Good Laboratory Practices (GLPs)
Experience in the design, conduct, and interpretation of GLP or non-GLP nonclinical pharmacology and toxicology studies
Experience supporting the development of gene therapy, small molecules, oligonucleotides, biologics, gene therapies and/or other therapies, including determining non-clinical program strategy and design. Experience in genotoxicity, especially as related to gene therapy is a big plus
Experience with the preparation of regulatory submissions (IND/CTDs, NDA/BLA, etc.) and communicating/ interacting with health authorities desirable
Strong critical, scientific, and strategic thinking skills; Strong problem solving and decision making abilities
Strong communication (verbal and written) skills
Experience and ability to work collaboratively in cross-functional teams
- Required: Masters (M.Sc.) or Doctorate (Ph.D.) or equivalent experience in molecular biology/genetics, pharmacology, toxicology or a related, relevant discipline.
8+ years of industry experience
- Intention to obtain Diplomate of the American Board of Toxicology (DABT) certification is a plus