Head of Regulatory Affairs

We are seeking a senior-level regulatory affairs professional to lead the registration of early stage prescription products for companion animal, equine and production animal. The successful candidate will drive the regulatory initiatives, provide regulatory expertise, industry contacts and proven success in the approval of new and innovative products for production and companion animals.

Qualifications include: 4+ years of experience in the veterinary pharmaceutical regulatory role with a proven track record with demonstrated success in achieving regulatory approvals for veterinary pharmaceuticals.  Experience should include writing submission to FDA CVM and obtaining NADAs. A scientific degree in a relevant biomedical subject (life sciences, biology, pharmacy, veterinary medicine, engineering). Experience working both independently and in multidisciplinary, geographically dispersed teams. Ability to prepare and present information to regulatory agencies and other scientific groups, experience submitting documents to CVM electronically, knowledge of European registration process is a plus and a solid understanding of the manufacturing and testing of veterinary pharmaceuticals. The successful candidate will have a “roll up your sleeves” attitude, be able to work in a fast paced environment and will be collaborative across functions. Domestic and international travel will be required.

To learn more and/or apply for this exciting opportunity, please  Apply Now.

Label Control Coordinator – Southwest

The incumbent will work with the Scientific Affairs Manager and will manage the development and inventory of all labels and packaging components. The incumbent will have significant contact with customer service and logistics and will provide regular reports on label issues and development status to the Scientific Affairs Manager.

Qualifications include a high school graduate, 3-5 years in the Animal Health Industry, basic management, including commercial and financial skills. A BS in Animal Science, Chemistry, Biological or Veterinary Science is preferred. Advanced certification or training is desirable.

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Lead Formulation Scientist – California

The incumbent will serve as formulation head for our client’s growing pipeline of prescription drug product candidates and non-prescription products. The incumbent will develop, plan and execute formulation projects, manage all aspects of CMO relationships including sourcing CMO’s preparing RFP’s, negotiating terms and determining budgets, along with managing development, optimization and production of formulated materials. The incumbent will implement formulation strategies in support of safety and efficacy studies, general pharmacology evaluations and toxicity evaluation.

Qualifications include a minimum of 5+ years of experience in animal health preformation, formulation development, drug discovery and drug delivery across a variety of delivery routes for companion and production animals. Experience formulating gastrointestinal products for companion and/or production animals strongly desired. Strong consideration will be given to the candidate with experience formulating solid and semi-solid dosage forms for the animal health industry.  Ph.D or an MS degree combined with the proper experience in formulation science from an accredited institution with strong emphasis in one or more of the following disciplines: biotechnology, biology, pharmaceutics, medicinal chemistry, chemical engineering, polymer science or pharmacokinetics, experience as a scientific leader and project manager a plus, proven understanding of cGMP, working knowledge of CMC Guidelines, experience working both independently and in multi-disciplinary, geographically dispersed teams, strong interpersonal and organizational skills, proactive self-starter with a roll-up-your –sleeves attitude and the ability to work independently, strong analytical and problem solving abilities, computer literacy in Excel and Word.

To be immediately considered for this opportunity, please  Apply Now.

Chief Veterinary Officer

The Chief Veterinary Officer (CVO) will facilitate the introduction a new proprietary technology to the Veterinary profession and thus in the creation of an entirely new product category in veterinary medicine, which will have a significant impact on treatment approaches and options for veterinary practitioners.  The CVO will lead the education-based, information-rich and phased introduction of the technology to the profession starting with universities and recognized experts in the field. Thus, in this role the CVO will develop and maintain knowledge in the technology’s clinical utilization by working closely with clinical investigators while building and maintaining credibility among the thought leaders in the arena.  The incumbent will work closely with universities, veterinary teaching hospitals and leading specialty clinics.  In this role, the incumbent will build and maintain relationships with key opinion leaders (KOLs) and ensure all appropriate research, literature and materials are provided to speakers and KOLs in support of participation at major veterinary conferences/meetings. Thus, the CVO will act to ensure the company has an outstanding reputation in the veterinary professions and will represent the company at external professional meetings and events.

Internally as a member of senior executive team, the CVO will serve as a resource for the Board of Directors and CEO providing strategic leadership in veterinary medicine, including medical educational strategies and potential new product/technology development.  The CVO will lead and execute product development, technical information development, and medical education/training programs.  The incumbent will work closely with the marketing and sales team in support of creation of product information sheets, technical bulletins, datasheets and articles and will ultimately build-out a veterinary team.

Qualifications include a DVM or VMD from an accredited school of veterinary medicine. Post-doctoral experience in canine or equine clinical practice is desired. A proven track record of success in launching and/or supporting new products, programs or professional initiatives is required.  The successful candidate will possess superior interpersonal and communication skills, strong organizational and leadership skills, and the ability to excel in a fast-paced, team-oriented, entrepreneurial environment. Startup experience would be beneficial.  Must be literate in use of Windows Office suite of software. There is a 40% to 60% travel requirement.  Flexible on location.

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Study Coordinator / Facilities Supervisor – Midwest

The incumbent is responsible for managing a clinical research technician staff and schedules, as well as managing the facility, ensuring facilities are prepared and ready for studies and proving quality data packages at the completion of a study. This includes site setup, study event planning, review of raw data and study event completion. The role entails facility setup and maintenance, maintaining knowledge of study protocols and providing staff for assisting study investigators with conduct of the study by management and planning of staff resources, inventory management, organize/set-up equipment for daily animal work, perform chores and feed and watering of animals, animal handing, ordering supplies, assure that the technical staff is trained on all aspects of study documentation, maintain training records, review SOPs revisions, assist with SOP reviews, literature reviews and data management, oversee the review/quality control of raw data documents throughout the study.

Qualifications include a BS degree in animal science, biology or equivalent experience, experience managing a staff of 4 to 5 technical employees, preferably in a clinical research setting. This would include working with poultry as well as other livestock, experience with Microsoft Word and Excel and understanding of farm animal husbandry systems, able to lift 75lbs.

To be immediately considered for this opportunity, please Apply Now.

Clinical Food Animal Research Veterinarian

The incumbent will serve as principal investigator and direct research studies to meet GCP or GLP standards and will provide leadership for clinical research team in the pursuit of excellence.  The incumbent will provide knowledge and innovation in the development of research models and study protocols.. The incumbent will oversee and provide animal care and handling that meets and/or exceeds IACUC and AWA standards and will lead the clinical study team in a manner that meets and/or exceeds study protocol and quality requirements and standards. The incumbent will manage the data capture system in cooperation with the QA Manager and third parties and will fulfill budgeting needs and expectations.

Qualifications include a licensed DVM with research experience in the animal health industry, experience in clinical diagnosis of common food animal diseases, strong scientific knowledge and understanding of large animal diseases, exceptional verbal and written communication skills, a commitment to providing first-rate client service, top notch animal care and handling skills, attentive to details and the ability to lead others to achieve high quality results, a high level of organizational skills and a willingness to work varied hours and weekends.

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Director of Product Development

The incumbent will lead the technical CMC and formulation activities from inception through product approval.

Qualifications include an MS or PhD in pharmaceutics, chemistry or similar discipline with 7+ years of experience in the field along with ability to design, develop and implement CMC/product development and validation activities. The successful candidates will have knowledge of GMP, ICH and FDA guidelines or regulations. Heavy travel is required.

To be immediately considered for this opportunity, please  Apply Now.