Job ID 4573 Company: Dechra Veterinary Products Job Location Portland, ME
Director US Product Development (Portland, ME)
Job RequirementsDechra is an international specialist veterinary pharmaceuticals products business. Our expertise is in the development, manufacture, sales and marketing of high quality products exclusively for veterinarians worldwide.
The Director US Product Development reports to the Group Director, Product Development and leads the US team of four Product Development Managers (senior scientists who lead the clinical and safety aspects of R&D projects and also provide overall leadership of projects). The Director and his/her team are accountable for delivering pilot and pivotal, clinical and non-clinical studies resulting in US NADA and ANADA approvals. Where requested the US Product Development Manager team may also be involved in studies to support approvals in the EU or the rest of the world. In addition, the Director and his/her team may also be assigned to the clinical and safety aspects of Due Diligence projects. The Director will ensure the US Product Development Manager team performs to -A- performance and collaborates effectively with other Dechra departments (e.g. EU Product Development Managers, CMC Product Development, Portfolio Management, Regulatory Affairs, Marketing, Quality Assurance, etc.).
Job Description* Support, develop and strengthen the Product Development Managers in leadership of project teams.
* Lead the US Product Development Manager team in planning, conducting, and reporting clinical and non-clinical studies.
* Ensure that studies are conducted in compliance with applicable requirements, including Standard Operating Procedures (SOPs), corporate policies, and regulatory requirements and guidelines (e.g., Good Clinical Practice and Good Laboratory Practice).
* Ensure the US Product Development Manager team provides technical and scientific support to Regulatory Affairs for existing products and products in the registration phase.
* Provide technical support to global, regional or local Marketing particularly in the launch phase of new products / indications.
* Facilitate effective working relationships between Product Development Managers and Clinical Trials Team and between different sites within the organization.
* Facilitate the preparation of scientific publications (article, posters or oral communications in congresses) of study results when requested.
* Monitor the activities and budgets on projects being conducted by the US Product Development Manager team. Identify when resource, time, and/or budget constraints occur and work with the Portfolio Manager and Product Development Managers to identify solutions.
* Ensure that the Group Director, Product Development is aware of the status of projects within the US Product Development Manager team and is informed of any material changes to the risk of development projects.
* Manage all team members to "A team" performance, moving promptly to address performance issues to resolution or termination.
* Represent the Group Director in leadership roles where requested.
Skills, Qualifications, Knowledge and Experience:
* DVM degree or PhD degree in relevant field. MS degree may be sufficient in the case of extensive job experience and prior accomplishments.
* Minimum 10 years of experience in clinical research or equivalent with proven track record of product approvals
* Excellent leadership and communication skills
* Demonstrated experience building and developing high performing teams
* Ability to manage international teams and work across cultures
* Strong scientific writing skills
* Travel potentially up to 25%
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