Director of Safety

Vacancies

Director of Safety

Job Introduction

*This is a remote position open to candidates located in the US

Invetx, a division of Dechra, is a veterinary biotechnology company focused on developing protein-based therapeutics for chronic conditions in companion animals, with an emphasis on monoclonal antibodies (mAbs). Our proprietary innovation platform integrates leading industry technologies to create species-specific, half-life extended mAbs that are longer-lasting, safe, effective, and more affordable than current treatments. As part of Dechra, a global leader in veterinary pharmaceuticals, Invetx supports Dechra's mission to sustainably improve global animal health and welfare.

The Director of Safety will progress the target animal and user safety development of Invetx's portfolio of development projects from nomination as development candidates through to global regulatory approval. The Director of Safety will play a key role in the progression of Invetx's development candidates from proof-of-concept to pivotal safety studies leading to regulatory approvals. The Director is directly responsible for the design and execution of an assigned portfolio of target animal and user safety studies to support the 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 safety strategies to achieve agreed project goals, ultimately leading to regulatory approvals.
• Participate in the creation of development plans (ex: timelines and budget), pilot and pivotal protocols and study reports.
• Execute pre-clinical, pilot and pivotal target animal and user safety studies including study setup, engagement and supervision of CROs, monitoring and study data interpretation.
• Ensure pre-clinical, pilot and pivotal target animal safety studies are executed to a high quality and in accordance with approved plans, internal SOPs, regulatory guidance and legal requirements.
• Assist the CDO and VP of Clinical in the development of appropriate safety strategies to obtain agreed project goals.
• Collaborate with Discovery and CMC personnel to ensure seamless and efficient progression of early-stage candidates from research to proof of concept to development and ultimately, to approval.
• Maintain up-to-date knowledge of the disease areas pertaining to assigned development candidates.
• Collaborate with the Dechra Target Animal Safety team to ensure alignment between teams.

For assigned safety studies:

• Develop budget for approval
• Identify and source required external resources to execute study
• Develop protocol
• Identify partner CROs, laboratories, investigators and other required resources
• Monitor timely execution of study and troubleshoot issues in collaboration with partners.
• Ensure appropriate QA/QC of study
• Oversee creation of study report
• Interpret study data and prepare for submission to regulatory agencies
• In dealing with external collaborators and stakeholders, 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

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:

• DVM or Equivalent
• Certification in Toxicology (DABT, ERT)
• Extensive experience within the animal health pharmaceutical industry with a focus on target animal safety and mAbs.Significant experience participating in cross-functional teams.
• Experience collaborating with regulatory agencies and other partners.
• Proven success in achieving objectives comparable to those of this position.
• Knowledge of the safety requirements for approval of veterinary biological non-immunological medicinal products (mAbs)in the US and EU.
• Experience as a GLP Study Director.
• Verbal and written communication
• Interpersonal interactions
• Expected travel 20-25% (domestic and international)

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.