Dechra Pharmaceuticals PLC
Director of Clinical Development (Invetx)
Dechra Pharmaceuticals PLC, Boston, Massachusetts, us, 02298
Vacancies
Directors 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.
Responsibilities
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:
Source and manage external partners (CROs, labs, investigators)
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
Qualifications
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
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 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.
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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.
Responsibilities
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:
Source and manage external partners (CROs, labs, investigators)
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
Qualifications
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
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 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.
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