The scope of the position is to manage and direct all activities of the special techniques group in support of the conduct of global preclinical safety studies for pharmaceutical, OTC and medical device candidates.

Minimum Qualifications:

- Veterinarian (DVM) with laboratory animal medicine, veterinary surgery or ophthalmology experience
- Board certification by ACLAM, ACVS, or ACVO preferred
- At least 8 + years with supervisory and preclinical study implementation or conduct of ophthalmic procedures.
- Demonstrated clinical aptitude in surgical procedures required. Training opportunities available.

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Other responsibilities include to participate in meetings with regulatory authorities to present and explain the position of our client company with respect to study requirements or concerns associated with the toxicology or safety of specific products. Establish partnership-based working relationships with scientific experts within regulatory authorities and facilitate the scientific and regulatory review process for our client’s products.  Incumbent will contribute to the risk assessment process by providing input to product safety managers/risk assessors on hazard identification, dose-response interpretation, use of mechanistic data and interpretation of toxicology profiles integrating information from other disciplines into the overall toxicological assessment. Incumbent will ensure Quality Assurance/Regulatory compliance and participate and/or lead administrative and procedural activities such as development of new Standard Operating Procedures.

Qualifications include PhD with board certification in toxicology or an advanced degree (MS or PhD) in addition to a DVM is desirable and should be in toxicology or a related field of pharmacology, pathology, etc.  Five or more years of experience in product development.

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Qualifications include a DVM and/or a PhD in an animal health related area. Preferred Qualifications include one or more years of experience in product development within or closely associated to the animal health pharmaceutical industry. Must possess the ability to organize and manage a variety of projects at any one time demonstrating attention to detail. Must possess good organizational skills and manage time efficiently. Must be self-motivated, possess good interpersonal skills and have the ability to lead and work within and across interdisciplinary teams. Travel is approx 25% within the United States. Limited international travel may be required.

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Qualifications include a DVM from an AVMA approved and accredited program. 3 years of surgical experience is required, with large animal surgical experience preferred. Advanced training, including veterinary surgical residency is preferred. Board Certification preferred. A minimum of 4 years of research experience is preferred. A Master’s or PhD is preferred. Preclinical study design and model development experience is strongly preferred. Experience as a Study Director/Leader for product evaluations is preferred.

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By combining their knowledge of scientific, legal and business issues, the incumbent insures the appropriate licensing strategy in order to license the veterinary biological product in the most expedient time. The person monitors regulations, both domestic and abroad, to ensure registration maintenance, compliance and product life cycle management guidelines are maintained and monitors and update changes to regulations to determine possible impacts on products. The position also ensures compliance for pharmacovigilance (adverse event processing and safety report submissions) to comply with US regulations.

QUALIFICATONS:

Education: M.S. in biology, or related life/medical science field and 5-7 years of direct Regulatory Experience or B.S. in biology, or related life/medical science field and 7-10 years of direct Regulatory Experience. Degree in Veterinary Medicine (DVM) preferred.

Work Experience: A minimum of five years experience in product registration is required. Incumbent needs to have knowledge and experience with The Center of Veterinary Biologics (USDA – 9 CFR), and working knowledge of the European Medicines Agency (EMEA), the US Food and Drug Administration (FDA) and other Regulatory Agencies (Canada, China, Japan, Asia Pacific, and Latin America).

Skills: Strong interpersonal and communications skills, and organizational and planning abilities needed to handle multiple tasks concurrently. Good computer (spreadsheet and database) skills.  

May require up to 20% travel (local, regional or international).

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Qualifications include MS in Virology/Microbiology/Biology, preferred PhD in Virology/Microbiology/Biology or DVM or related degree. Need 5 years experience in Veterinary biological R&D; direct USDA license experience.

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Qualifications include three years experience in vaccine production, preferably in viral egg fluid production.   Supervisory experience required. Excellent communication skills are required.   Must be able to perform advanced math and technical writing functionsThe incumbent will manage R&D scientific services for support of biological products and to ensure timely management of autogenous vaccines in R&D.  Coordinate, manage and communicate results of approved controlled and field trials, field safety trials and workflow of the Autogenous R&D Laboratory, workflow of Laboratory Services and Animal Services.

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Qualifications:  Ph.D and/or DVM, 5-10 years of experience managing controlled and field trials, 3-5 years experience managing a diagnostic laboratory, knowledge of modern poultry industry practices, familiarity with USDA regulations governing licensed and experimental biological products.

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Qualifications include advanced scientific degree (ex. DVM, PhD). 7-10 years in industry, 3+ years in leadership capacity.

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