Position Summary and Responsibilities:
Working with other Metabolism & Safety staff, the incumbent will serve VMRD needs for expertise in target animal safety (TAS), drug development and regulatory filing within the Safety Sciences Group. This person will spend much of their time providing the expertise to assure that target animal safety needs are foreseen and met during the drug development process in VMRD according to all global standards for TAS information. The candidate will work with a range of projects from early discovery through full development and post-approval primarily for large molecules, across therapeutic areas and across species. We are looking in particular for a candidate with experience in studies with biotherapeutics (such as monoclonal antibody therapeutics).
This candidate will author and review safety study protocols to be conducted by VMRD staff, monitor safety studies conducted at CROs, and may serve as a GLP study director for safety studies conducted in Zoetis facilities. The incumbent will provide consultation to Research teams to help them design early TAS strategy and study design. For products later in development, the incumbent will devise the safety strategy and carry out that plan according to regional needs. Working with VMRD Regulatory Affairs, the incumbent will be expected to remain current with global regulatory requirements relating to target animal safety.
The candidate should have a strong understanding of pharmacology, toxicology and immunology, and a successful candidate will be able to understand how basic biology may inform clinical findings from safety studies The candidate should be able to liaise with experts in other toxicology specialties. In addition, the candidate will be competent to search and interpret toxicology and immunology literature to assist teams with understanding potential safety concerns.
The incumbent will participate actively in the authoring and review of regulatory submissions of compounds for approval for marketing status worldwide.
Although travel is restricted currently, there is an expectation that at some time, travel to CROs and regulatory bodies will resume to support drug development plans and the conclusions of the studies conducted to support the drug safety of veterinary products. Working with other team members, this person will participate as a representative regarding budget projections, project planning, and urgent team needs.
This position will be hired remotely; however, the candidate should be aware that eventual relocation to Kalamazoo may be considered for the position.
Minimum skills, education, experience, attributes:
- DVM (or equivalent) plus at least 5 years of experience in a related animal health field
- Experience in clinical immunology pharmacology or toxicology
- Experience in leading and directing others, especially in the execution of studies
- Demonstrated skills in technical writing (protocols, reports, expert statements, journal articles) as well as oral communication skills in scientific venues are required
Desirable skills, education, experience, attributes:
- PhD and/or Board Certification in a veterinary specialty is desirable
- Knowledge and experience with biopharmaceuticals
- Veterinary clinical practice experience is highly desired
- Experience in the design, implementation, and interpretation of GLP studies evaluating toxicity of compounds is desired, as well as experience as a GLP Study Director