Senior Principal Professional - Veterinary Clinical Development

Vacancies

Senior Principal Professional - Veterinary Clinical Development

Job Introduction

Thanks for checking out our vacancy, we're delighted you want to learn more about Dechra!

Dechra is an international specialist veterinary pharmaceuticals products business. Our expertise is in the development, manufacture, and sales and marketing of high quality products exclusively for veterinarians worldwide.

Here at Dechra, our values are embedded within our culture and thrive within our family of over 2500 colleagues globally. From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do business.

The Opportunity

A Principal Scientist / Senior Principal Scientist within the Global Clinical team will work on a diversity of US, EU or Global research and development projects for veterinary medicines to obtain regulatory approval(s) in Dechra's target markets. They may act as the Project Lead (if suitably experienced) and/or the technical lead for all efficacy aspects of one or more development projects. As such, they will lead and/or work within a team planning, designing, executing and reporting the programme of studies required to determine and demonstrate efficacy.

Role Responsibility

So, what will you be doing? This role has a broad and varied scope and the successful candidate will have responsibility for duties including:

• Work closely with multiple different functions on multidisciplinary teams (and with experience, may be asked to lead such R&D project teams), with colleagues from across the Dechra organization including portfolio management, global product development, regulatory affairs, strategic and local marketing and manufacturing.
• Design and establish pre-clinical drug candidate screening processes for research programmes, or to design and prosecute the development studies required for regulatory submissions to bring products to market.
• Collaborate with third parties (CRO's, expert consultants, clinical practitioners and key opinion leaders), writing study protocols, interpreting, reporting and presenting study data and assembling the technical sections of regulatory submissions.
• Operating with a team of multi-disciplinary colleagues to plan and design a programme of studies required to demonstrate the safety and efficacy for one or more of Dechra's drug development candidates to support veterinary product registration in US and/or Europe.
• Planning, designing, executing and reporting the studies (laboratory and field) required to determine and demonstrate the efficacy of a drug development candidate.
• Investigating new diseases and potential therapies to design drug development programmes to determine efficacy.
• Provision of technical clinical support to Dechra commercial colleagues as and when requested to do so to support Dechra's portfolio of marketed products.
• Support Dechra's existing portfolio of marketed products with detailed scientific and technical knowledge on request.

The Ideal Candidate

Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We're particularly excited to hear from those who have/are:

• Graduate veterinarian (D.V.M., B.V.Med., or equivalent).
  (Candidates with a biomedical or animal science degree and significant experience in veterinary drug development and registration will also be considered.)
• Significant veterinary pharmaceutical/ biopharmaceutical industry experience with a working understanding and hands-on experience of all aspects of investigational veterinary product development in accordance with relevant guidelines (e.g. VICH, GCP and GLP), including study design/ protocol development/ study execution/ reporting, and dossier preparation for regulatory submission and interaction with governmental agencies for veterinary product registration.
• Excellent interpersonal and communication skills, both oral and written; ability to make the complex clear.
• Proven ability to collaborate cross-functionally in a multicultural/international, matrix environment.
• Comfortable with challenging others and to being challenged on technical matters in a professional manner
• Experienced in companion animal or equine clinical practice or research
• Experience of small and/or large molecule veterinary medicine R&D.
• Experience of US veterinary regulatory agency organizations (FDA-CVM and/or USDA), their regulations and guidelines.

Desirable:

• Advanced degree (MSc, PhD, doctorate), specialty board certification or diploma an advantage.
• First-hand experience working with, setting up and validating in-vitro and/or in-vivo disease models.
• A track record of successful delivery of one or large-scale companion field efficacy and safety studies.
• Experience of international regulatory organization requirements (for example EMA-CVMP, UK-VMD, AUS-APVMA).
• A market-led mindset in the application of scientific research.
• Working knowledge of pharmacokinetics

About the Company

As a people first values-based culture, we provide free weekly wellness sessions focused on our employee's physical and mental wellbeing, and flexible work arrangements. We offer a generous employer 401k match and an other incentives for long-term financial wellness. Our full array of health, financial and voluntary benefit programs are what you would expect from a recognized Best Place to Work.