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Job Introduction

Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra Pharmaceuticals PLC.

Dechra is a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.

Here at Dechra, our values are embedded within our culture and thrive within our family of almost 2000 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

Dechra Pharmaceuticals PLC is a UK-based, global business involved in the development and marketing of veterinary products for dogs, cats, horses and food producing animals. Global Drug Safety at Dechra provides scientific leadership for early-stage programs through to marketed products. We are seeking a Safety Lead to be a part of our Team responsible for comprehensive safety evaluation of Dechra products.

Main Responsibilities

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

• Serves as the Safety Technical Lead in the Project Team to define and implement safety strategy
• Has knowledge of regulatory requirements for safety and toxicology testing for veterinary product development and serves as a resource for this information, ensuring that appropriate elements of safety and toxicity are addressed in data collected to support regulatory submissions
• Directs and delivers the design, execution, interpretation, and reporting of safety studies
• Responsible for mechanistic toxicology studies, when necessary, and the preparation of animal and human health risk assessments
• Manages and develops both internal and external resources for the execution of safety strategies
• Acts as Study Monitor and directs the design and scope of protocols to evaluate product safety in target and non-target species and interprets safety study data to ensure appropriate reflection of findings in study reports
• Establishes requirements and generates toxicological data required to establish MOE, ADI, POD, and MRL values for preparation of animal and human health risk assessments
• Responsible for presentations or discussions with VMD, EMA, FDA and other relevant regulatory agencies on issues related to safety; prepares data reviews or position papers to resolve regulatory issues pertaining to drug safety
• Responsible for the preparation of drug submissions for Veterinary Medicinal Products / New Animal Drugs
• Provide Safety support across products, materials, ingredients, technologies, and manufacturing processes
• Publishes research in peer reviewed publications, and presents research at internal and external scientific venues, as appropriate

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:

• PhD in Toxicology and/or similar field with a minimum of 3 years relevant industry experience
• Board certification in toxicology (DABT) preferred
• Maintenance of professional certification(s) through training and continuing education
• Advanced knowledge of toxicology & DMPK
• Experience with regulatory safety requirements and risk assessment strategies in Animal Health
• Expert knowledge of Good Laboratory Practices (GLP) – GLP study director experience is a plus
• Experience managing project budgets and timelines
• Excellent interpersonal, intercultural communication and networking skills
• Ability to work effectively in a matrix environment
• Ability to effectively multi-task and work under pressure with multiple competing priorities

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 employee stock purchase plan 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.