JOB SUMMARY: Toxicology
The candidate will provide scientific oversight and strategic guidance for nonclinical safety evaluation programs from late-stage research through all phases of the drug development process including market application. reporting to the Senior Director Nonclinical Safety Evaluation.
This individual will participate in the pharmacological and toxicological assessment at Company by developing and implementing nonclinical strategies, including creating a best-evidence synthesis of existing knowledge and by designing, executing, interpreting, investigating toxicity relationships and reporting data that elucidates the toxicologic/pharmacologic profile of gene therapy and gene editing/regulating candidates. This individual will work collaboratively with internal and external cross-functional teams, collaborators and consultants to design and efficiently execute nonclinical programs that support clinical development and regulatory submissions. The comprehensive analysis and interpretations of non-GLP and GLP studies will be reported and defended to regulatory agencies in meetings and documents including the IND/CTA, annual reports, investigator brochures, special protocol assessments and market applications. The successful candidate will have an extensive pharmacology/toxicology background, along with biologics and/or gene therapy development experience as well as a strong understanding of Good Laboratory Practices (GLPs) that will provide broad-based support to align the nonclinical efforts with the company’s philosophy on drug development.
- Develop and implement nonclinical strategies
- Design, execute, interpret and report nonclinical studies to support cDNA and zinc finger protein and zing finger nuclease-based gene therapy compounds in late-stage research and all stages of nonclinical/clinical development
- Represent the department at Core Teams and provide expert advice and direction on development programs.
- Lead nonclinical development sub teams and actively support the integration of nonclinical activities in Company’s drug development paradigm
- Provide scientific leadership influence across the organization and support cross-functional strategy initiatives.
- Work with disease models of pharmacology and toxicology
- Work closely with scientists and other functions across Company departments and project teams to ensure effective product development efforts.
- Develop target safety assessment and integrated pharmacology/toxicology summaries of investigational gene therapy candidates for internal decisions and regulatory submissions
- Interact with CROs, university laboratories, collaborators and consultants as necessary to ensure timely study completion, report production and progression of Company nonclinical projects
- Communicate effectively cross-functionally to accomplish company goals.
- Represent the company at scientific and professional meetings and conferences.
- Maintain a high level of professional expertise through awareness of current and emerging standard practices and guidelines, and familiarity with scientific literature in toxicology and nonclinical safety evaluation
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
- Doctorate (PhD) in toxicology or closely related field of study, with a minimum of 8+ years of nonclinical experience in the pharmaceutical and/or biotechnology field
- Preference to candidates with Academic training in toxicology, pathology or related discipline, preferably with advanced degree (Ph.D., D.V.M.) and board certification (DABT, DACVP)
- Strong understanding of drug development
- Extensive experience in the design and conduct of nonclinical pharmacology and toxicology studies to support product registration
- Experience with managing studies conducted at CROs and academic labs
- Familiarity with CDER/CBER/ICH guidelines for new product development
- IND/CTA and NDA/BLA development experience
- Ability to build and foster cross-functional collaborations both internally and externally at Company
- Excellent written and verbal communication skills
- This position will have a hybrid schedule on location at either our Brisbane or Point Richmond facility and will require occasional travel to the other office as needed.