Job Introduction
This is a US remote role, with a preference for candidates based in the Boston area.
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 primary function of the Chief Development Officer is to ensure the progression of Invetx's portfolio of development projects from nomination as development candidates through to global regulatory approval. The Invetx portfolio consists of novel monoclonal antibodies targeting important diseases in companion animals. The CDO is directly responsible for the Clinical Development and Regulatory Affairs teams and works in partnership with the Chief Technology Officer for CMC development and manufacturing related regulatory activities. The breadth of responsibilities encompasses proof-of-concept studies, pilot and pivotal clinical studies and regulatory interactions and submissions leading to approval of the NADA/Marketing Authorizations/Product Licenses for the portfolio of development candidates. The CDO supervises the Clinical and Regulatory Affairs teams and assists the President in defined areas including strategy, regulatory responsibilities, and communications.
Main Responsibilities
- Develop and execute successful clinical and regulatory strategies to achieve agreed project goals, ultimately leading to regulatory approvals.
- Lead the Clinical Development and Regulatory Affairs teams to ensure pre-clinical, pilot and pivotal effectiveness and target animal safety studies are executed to a high quality and in accordance with approved Plans, internal Quality standards, regulatory guidance and legal requirements.
- Develop and approve appropriate clinical and regulatory strategies to obtain agreed project goals.
- Build Invetx's development organization to support future growth and development plans.
- Participate in the planning of associated clinical studies, timelines and budgets and guide the team in the execution of clinical studies.
- 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.
- Participate in the development of project plans, pilot and pivotal protocols and study reports.
- Ensure pre-clinical, pilot and pivotal effectiveness and target animal safety studies are executed to a high quality and in accordance with approved plans, regulatory guidance and legal requirements.
- Approve budgets for development programs and deliver programs to approved budgets.
- Identify program risks and create and implement mitigation strategies.
- Develop appropriate regulatory strategies leading to approval of Invetx's product candidates,
- Create and/or review and approve all regulatory documentation submitted to government regulatory agencies in particular FDA, USDA and EMA.
- Lead meetings and other interactions with the relevant regulatory agencies,.
- Maintain knowledge of current regulations, policies and guidances of regulatory agencies and associated bodies.
- Review and approve high-quality documentation pertaining to the effectiveness and target animal safety technical sections of dossiers and collaborate with Invetx's CMC group for CMC technical sections, to ensure timely filing with the appropriate regulatory agencies.
- Ensure proficiency in electronic dossier submission.
- 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
- Doctor of Veterinary Medicine (DVM) or equivalent.
- 10+ years of experience in a R&D position within the Animal Health pharmaceutical industry, preferably focused on product development.
- 10+ years of experience participating in cross-functional teams.
- Experience interacting with regulatory agencies at a senior level.
- Proven success in achieving regulatory approval of veterinary products.
- Experience collaborating with CROs and other external vendors.
- Demonstrated success in achieving objectives comparable to those of this position.
A high level of proficiency in the following areas is required:
- Verbal and written communication skills.
- 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 setting.
- Microsoft Office, Adobe, and specific regulatory agency software.
- Planning, managing, and delivering long-range projects, such as regulatory approvals.
- Understanding and application of relevant regulatory guidances.
- Development of protocols, data capture systems, execution of studies, and data interpretation.
Desirable
- PhD, preferably in a veterinary clinical discipline
- Previous experience in a biotech start-up applied to animal health.
- Experience in the safety assessment of veterinary products
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.
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