Dechra Development LLC
Product Development Manager
Overland Park, Kansas
Broad Function:
Project Team Leader for pharmaceutical compounds in research and development
Essential Functions:
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Lead the project team through the research and development process to gain registrations
Design and implement the product development operating plan (tasks, timings, and costs)
Lead the Clinical Trial Managers in the design of protocols for studies
 Preliminary safety, metabolism, pharmacokinetics, and proof-of-concept studies
 Dose determination studies and/or pharmacokinetics studies
 Pivotal efficacy studies, safety studies and field trials
Responsible for negotiations with VMD, EMA, FDA and other relevant regulatory agencies
Responsible for preparing the Part IV Section of the dossier
Responsible for project-related proposals to the Senior Executive Team
Lead life cycle management projects as needed
Knowledge, Skills, and Abilities:
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Experience leading project teams within veterinary drug development including interaction
with governmental agencies
Understanding of all aspects of product development, including formulation development,
analytical method development, GMP stability batch production/release, protocol
development, GCP guidelines, study reports, and dossier preparation
Ability to lead diverse project team members located in the US and/or EU
Ability to travel
Requirements:
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Graduate veterinarian (D.V.M., B.V.Sc., or equivalent), experience in veterinary practice a
plus
Advanced degree or specialty board certification a plus
Veterinary industry experience as an R&D Project Leader
Please send your CV to Chris Huettner, Human Resource Manager,
recruitnorthamerica@dechra.com.