Principal Research Toxicologist
- The Principal Research Toxicologist plans, develops and executes the toxicological study of pharmaceutical drug candidates. This individual will identify, evaluate and manage appropriate Contract Research Organizations (CROs) to perform non-GLP and GLP in vitro and in vivo studies to support candidate assessment and regulatory filings. The Principal Research Toxicologist will serve as an expert resource for safety and toxicological information and will be responsible for the toxicology strategy to support preclinical development and first in human regulatory filings. Additionally, this researcher is expected to actively lead and participate in the planning and execution of related pharmacology and pharmacokinetic studies to support early drug development.
- ESSENTIAL FUNCTIONS:
- · Design, monitor and execute GLP safety pharmacology and toxicology studies at a CRO.
- · Prepare, negotiate and maintain agreements for research and developmental studies with outside contractors and academic researchers.
- · Participate in the organization, preparation and review of the Pharmacology and Toxicology sections of IND or NDA submissions; Modules 2.4 and 4.0 of the CTD.
- · Serve as an in-house expert for general toxicological issues and Provide toxicological expertise and regulatory strategy to project teams.
- · Thorough knowledge of GLP and GMP requirements for regulatory submissions of new chemical entities for the US, Europe and Japan.
- · Ability to interpret, describe and present results in a concise manner to peers, team members and upper management.
- · Critique and edit reports as appropriate.
- · Understand the environmental and occupational regulation that apply to the manufacturing and distribution of new pharmaceutical products.
- · Provide general toxicological assessments as needed.
- · Understands, performs and interprets studies to assess ADME, including biodistribution, PK and metabolism.
- · May act as technical lead for specific drug development projects.
- DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
- · Other duties as assigned with or without accommodation.
- MINIMUM REQUIREMENTS:
- Education:
- · A PhD or DVM in toxicology, pharmacology, physiology or other toxicology-related science is required.
- Experience:
- · Minimum of 6-8 years of experience with at least 5 years relevant pharmaceutical industry experience as a Toxicologist or Senior Toxicologist is required.
- Preferred Skills/Qualifications:
- DABT certification is highly desirable.
- · Knowledge of relevant scientific disciplines including drug metabolism, drug transport, formulation sciences, biopharmaceutics, pathophysiology and therapeutics.
- · Knowledge of FDA and ICH guidance and regulations
- · Record of successful publications in the areas of pharmacology, toxicology general mechanism and drug development.
- Skills/Competencies:
- Ability to organize and work simultaneously on multiple projects.
- Ability to work in a matrix, project-oriented environment.
- Excellent written and oral communication skills, interpersonal/influencing skills, and ability to work in a continually changing environment.
- ORGANIZATIONAL RELATIONSHIPS/SCOPE:
- This position will report to the Director Pharmacology in Department of Research and have frequent contact with other departments within Science & Technology (i.e. Research, Regulatory, Clinical Development, and Program Management).
- WORKING CONDITIONS:
- Normal Office Conditions
- DISCLAIMER:
- The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.