Director of Clinical Development (Invetx)

Vacancies

Director of Clinical Development (Invetx)

Job Introduction

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

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 3000 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

Invetx Inc., a Dechra division, is a veterinary biotechnology company based in the USA that is engaged in the discovery and development of novel therapeutic proteins for the treatment of important diseases in the veterinary species, initially focused on companion animals. Using a proprietary platform that combines industry-leading technologies from partners ─AbCellera, Twist BioPharma and WuXi Biologics─ Invetex is developing several fully species-specific monoclonal antibodies for veterinary use. In July 2024 Dechra Pharmaceuticals acquired Invetx. Invetx continues its focus to bring differentiated biotherapeutics for dogs and cats to the Animal Health market as its own Division within the Dechra organisation.

In this role you will lead the clinical advancement of Invetx's development candidates from nomination through to global regulatory approval in key markets (US, EU, and beyond). You will be responsible for designing and executing a portfolio of clinical studies that support the effectiveness sections of regulatory submissions, including NADA, Marketing Authorizations, and Product Licenses. This role is pivotal in transitioning candidates from proof-of-concept to pivotal trials, driving regulatory success.

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:

• Support the Chief Development Officer (CDO) and Director of Clinical Research and Development in shaping and implementing clinical strategies to achieve project goals and regulatory approvals
• Serve as the Clinical Lead on cross-functional project teams, responsible for the clinical development strategy and execution of assigned projects
• Lead the design and execution of preclinical (PK, proof of concept lab studies, etc.), pilot, and pivotal field efficacy studies, including protocol development, CRO and investigator engagement, study monitoring, data interpretation, and reporting
• For assigned studies: o Source and manage external partners (CROs, labs, investigators) o Develop and manage study budgets
• Ensure timely, high-quality execution and QA/QC compliance
• Interpret results and author Final Study Reports
• Identify program risks and implement mitigation strategies
• Author and collaborate in the preparation of high quality regulatory submissions to FDA, USDA, and EMA • Collaborate with Discovery and CMC teams to ensure seamless transition of candidates from research to development
• Maintain up-to-date knowledge of relevant disease areas and therapeutic targets
• Represent Invetx in interactions with external collaborators and stakeholders, consistently demonstrating professionalism, integrity, and the entrepreneurial spirit of Dechra.
• Act with integrity and uphold high ethical standards in all professional activities

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:

• Doctor of Veterinary Medicine (DVM) or equivalent
• 5+ years of experience in R&D within the Animal Health pharmaceutical industry, conducting GCP and GLP studies, preferably focused on companion animal product development
• Experience in collaborations with CROs and other external vendors
• Experience with regulatory agencies (FDA-CVM, USDA, EMA)
• Strong communication, organizational, and cross-functional collaboration skills
• Experience participating in cross-functional teams • Understanding and application of relevant regulatory guidances
• Development of protocols, data capture systems, execution of studies, and interpretation of data
• Willingness to travel (~20%) Travel to regulatory agencies, partner CROs/clinical sites, Invetx office (Boston, MA), meetings and events, academic collaborators and KOLs of relevance to the product portfolio, conferences and other locations as required. Travel will be mainly domestic (US) but international travel may also be required

Desirable

• Advanced degree (MSc, PhD, doctorate, Diplomate), preferably in a veterinary clinical discipline
• Experience with biologics and safety assessments
• Experience with in vitro/in vivo disease models and large-scale field studies

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.