Dechra Pharmaceuticals PLC
Director of Clinical Development
Dechra Pharmaceuticals PLC, Boston, Massachusetts, us, 02298
Vacancies
Director of Clinical Development
Job Introduction
This role is based in Boston, MA, with the option for hybrid or remote work.
Invetx, a Division of Dechra, 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 focused on companion animals. 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 organization.
The Director of Clinical Development will progress the clinical development of Invetx's portfolio of development projects from nomination as development candidates through to global regulatory approval. The Director will play a key role in the progression of Invetx's development candidates from proof-of-concept to pivotal clinical studies leading to regulatory approvals. The Director is directly responsible for the design and execution of an assigned portfolio of clinical studies to support the effectiveness and target animal safety technical sections of the NADA/Marketing Authorizations/Product Licenses for assigned development candidates.
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:
Develop and execute successful clinical strategies to achieve agreed project goals, ultimately leading to regulatory approvals.Participate in the creation of development plans, pilot and pivotal protocols, and study reports.Execute pre-clinical, pilot and pivotal effectiveness and target animal safety studies including study setup, engagement and supervision of CROs, monitoring and study data interpretation.Ensure studies are executed to a high quality and in accordance with approved plans, internal SOPs, regulatory guidance, and legal requirements.Assist the VP of Clinical and Regulatory Affairs in the development of appropriate clinical strategies to obtain agreed project goals.Participate in the planning of associated clinical studies, timelines, and budgets.Collaborate with Discovery and CMC personnel to ensure seamless and efficient progression of early-stage candidates from research to proof of concept to clinical development and ultimately, to approval.Maintain up-to-date knowledge of the disease areas pertaining to assigned development candidates.Identify and source required external resources to execute studies.Develop budget for approval.Develop protocol.Identify partner CROs, laboratories, investigators, and other required resources.Monitor timely execution of studies and troubleshoot issues in collaboration with partners.Ensure appropriate QA/QC of studies.Oversee creation of study reports.Interpret study data and prepare for submission to regulatory agencies.Present Invetx as an innovative and entrepreneurial division of Dechra, setting high professional work standards and pursuing goals with honesty, respect, determination, and energy.Act with integrity and in an ethical manner.
The Ideal Candidate
- 5+ years of experience in a R&D position within the Animal Health pharmaceutical industry preferably focused on companion animal clinical development.
- 5+ years' experience participating in cross-functional teams.
- Doctor of Veterinary Medicine (DVM) or equivalent.
- Experience in collaborations with CROs and other external vendors.
- Previous success achieving objectives comparable to those of this position.
A high level of proficiency in the following areas is required:Verbal and written communication.Interpersonal interactions.Building strong relationships with relevant stakeholders.Participating and performing effectively within cross-functional teams.Working in a remote-office environment and in a virtual project team environment.Microsoft Office software.Planning, managing, and delivering clinical programs leading to regulatory approvals.Development of protocols, data capture systems, execution of studies, and interpretation of data.
DesirableClinical development experience in the area of veterinary biologics particularly those regulated by the USDA Center for Veterinary Biologics in the USA.Experience in the safety assessment of veterinary products.PhD, preferably in a veterinary clinical discipline.
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 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.#J-18808-Ljbffr
Director of Clinical Development
Job Introduction
This role is based in Boston, MA, with the option for hybrid or remote work.
Invetx, a Division of Dechra, 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 focused on companion animals. 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 organization.
The Director of Clinical Development will progress the clinical development of Invetx's portfolio of development projects from nomination as development candidates through to global regulatory approval. The Director will play a key role in the progression of Invetx's development candidates from proof-of-concept to pivotal clinical studies leading to regulatory approvals. The Director is directly responsible for the design and execution of an assigned portfolio of clinical studies to support the effectiveness and target animal safety technical sections of the NADA/Marketing Authorizations/Product Licenses for assigned development candidates.
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:
Develop and execute successful clinical strategies to achieve agreed project goals, ultimately leading to regulatory approvals.Participate in the creation of development plans, pilot and pivotal protocols, and study reports.Execute pre-clinical, pilot and pivotal effectiveness and target animal safety studies including study setup, engagement and supervision of CROs, monitoring and study data interpretation.Ensure studies are executed to a high quality and in accordance with approved plans, internal SOPs, regulatory guidance, and legal requirements.Assist the VP of Clinical and Regulatory Affairs in the development of appropriate clinical strategies to obtain agreed project goals.Participate in the planning of associated clinical studies, timelines, and budgets.Collaborate with Discovery and CMC personnel to ensure seamless and efficient progression of early-stage candidates from research to proof of concept to clinical development and ultimately, to approval.Maintain up-to-date knowledge of the disease areas pertaining to assigned development candidates.Identify and source required external resources to execute studies.Develop budget for approval.Develop protocol.Identify partner CROs, laboratories, investigators, and other required resources.Monitor timely execution of studies and troubleshoot issues in collaboration with partners.Ensure appropriate QA/QC of studies.Oversee creation of study reports.Interpret study data and prepare for submission to regulatory agencies.Present Invetx as an innovative and entrepreneurial division of Dechra, setting high professional work standards and pursuing goals with honesty, respect, determination, and energy.Act with integrity and in an ethical manner.
The Ideal Candidate
- 5+ years of experience in a R&D position within the Animal Health pharmaceutical industry preferably focused on companion animal clinical development.
- 5+ years' experience participating in cross-functional teams.
- Doctor of Veterinary Medicine (DVM) or equivalent.
- Experience in collaborations with CROs and other external vendors.
- Previous success achieving objectives comparable to those of this position.
A high level of proficiency in the following areas is required:Verbal and written communication.Interpersonal interactions.Building strong relationships with relevant stakeholders.Participating and performing effectively within cross-functional teams.Working in a remote-office environment and in a virtual project team environment.Microsoft Office software.Planning, managing, and delivering clinical programs leading to regulatory approvals.Development of protocols, data capture systems, execution of studies, and interpretation of data.
DesirableClinical development experience in the area of veterinary biologics particularly those regulated by the USDA Center for Veterinary Biologics in the USA.Experience in the safety assessment of veterinary products.PhD, preferably in a veterinary clinical discipline.
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 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.#J-18808-Ljbffr