Chief of Project Management – West Coast

The Chief of Project Management will report to the CEO and each of the project managers will be accountable to this position.  This leader will assist with training team members and will create plans that address the following:

Agreeing on team objectives with senior management, both short and long term and creating plan, organizing team members and meeting on a regular schedule as needed, generating timelines, both for detailed project management as well as acceptable format for senior management and board of directors, generating critical path activities, identifying and generating risk management program for plan, including in particular the critical path activities.

Qualifications include Pharmaceutical industry drug development training and project management experience. The preferred candidate will be a veterinarian.

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Director of Business Development

The Director of Business Development will oversee and direct global partnerships for the organization and will lead expansion into new markets and manage industry partners and collaborations.  The incumbent will secure and manage distribution partners both domestically and abroad. In addition, the incumbent will direct and execute market entry strategies working alongside regulatory and sales teams and will expand the pipeline and create new revenue streams by seeking out and negotiating partnerships, acquisitions and licensing opportunities.  The incumbent will help build a team of highly qualified individuals to help evaluate incoming opportunities and will help to identify financing opportunities to support growth of new markets.

Qualifications include Bachelor’s degree, with MBA preferred, previous experience designing and negotiating technical licensing, M&A and partnership deals, particularly in the pharmaceutical and biotechnology sectors, experience successfully managing distributors and industry partners, track record of success in meeting and exceeding objectives, effective, professional, communication and presentation skills, knowledge of intellectual property is preferred, ability to thrive in an entrepreneurial work environment.

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Chief Veterinary Officer – west coast

The Chief Veterinary Officer will develop and commercialize veterinary prescription and non-prescription products. The incumbent will oversee all clinical programs, including the planning, development and execution of clinical trials. Other responsibilities include developing effective study protocols, ensuring that study timelines and clinical endpoints align with the organization’s product development directives, regulatory requirements, clinical budgets and commercialization milestones.

Qualifications include DVM/VMD or equivalent, extensive experience overseeing clinical programs in a corporate environment, including the development of study protocols and the strategic planning, development and execution of clinical trials. The successful candidate will be experienced leading teams of clinical veterinarians and will have a proven track record of success supporting the commercialization of veterinary prescription and non-prescription products in the production animal and/or companion animal markets from a clinical development perspective. A proven track record of success interfacing with the FDA’s CVM, thorough understanding of GLP and GCP guidelines pertaining to veterinary clinical programs, proven understanding of FDA/CVM study design requirements, superior interpersonal and communication skills, strong organizations and leadership skills and the ability to excel in a fast-paced, team-oriented environment. Detailed knowledge of animal health issues and veterinary practice issues, exceptional strategic and critical thinking skills and problem-solving abilities, excellent oral, written and presentation skills, ability to travel nationally and occasionally internationally (there is a 40% to 60% travel requirement). Strong computer skills, including proficiency with the Windows Office suite and the ability to master new technology tools quickly.

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Senior Project Manager – west coast

We are seeking an experienced project management professional to support Clinical Operations, Regulatory Affairs and Manufacturing with the planning and tracking of multiple new and ongoing projects. The incumbent will employ project management tools and methodologies to support and manage the development, coordination and ongoing tracking of multiple clinical and regulatory initiatives.

Qualifications include a proven track record of effectively applying project management tools and methodologies to manage and support the development, coordination and tracking of complex clinical and regulatory initiatives. As Senior Project Manager; you will interface daily with members of Clinical Operations, Regulatory Affairs and Manufacturing teams as well as external partners. Excellent communication skills are essential.  Other qualifications include a BS/BA  with 7+ years of experience in project management, 5+ years of project management experience in the pharmaceutical or life sciences space, expertise with project management software and other technical tools used in managing large projects, high proficiency with MS Office and ability to quickly master other software tools, Project Management Professional (PMP) Certification a big plus, proven ability to prioritize and execute tasks with minimal direction or supervision, work independently and meet tight deadlines in a fast-paced and demanding working environment, skilled in working with cross-functional project teams including Clinical Operations, Regulatory Affairs, Quality Assurance, Manufacturing and Marketing, excellent interpersonal, written and communication skills, exceptional analytical and problem-solving abilities, proactive self-starter with a roll-up-your-sleeves attitude, attention to detail and follow-through a must, general understanding of animal health product development and regulatory processes a plus.

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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.

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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.

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