Product Development Manager, Clinical

Dechra   •  

Portland, ME

Industry: Business Services

  •  

5 - 7 years

Posted 350 days ago

Job Requirements:
• Graduate veterinarian (D.V.M., B.V.Med., or equivalent), experience in veterinary practice a plus
• Advanced degree or specialty board certification a plus
• 5+ years of veterinary industry experience with a working understanding and hands-on experience with all aspects of investigational veterinary product development in accordance with relevant guidelines (e.g. VICH, GCP), including study design/ protocol development/ study execution/ reporting, and dossier preparation
• Participation on cross-functional product development teams as a R&D Project Leader with experience leading project teams within veterinary drug development including interaction with governmental agencies
• Ability to lead diverse project team members located in the US and/or EU
• Ability to travel both domestically and internationally
Job Description:
The Project Team Leader will lead one or more global clinical development projects for pharmaceutical compounds in research and development through all stages required to obtain regulatory approval for sale in global markets.Specific responsibilities include:
• Preparation, design, and implementation of the product development operating plan including tasks, timing and costs for pre-clinical, pilot and pivotal effectiveness and target animal safety studies;
• Interpretation of study data;
• Dossier preparation (e.g. Efficacy Technical Section, Safety Technical Section, Part III, Part IV);
• Responsible for project-related proposals to the Senior Executive Team;
• Lead life cycle management projects as needed;
• Interaction with Regulatory Agencies, principally FDA, EMA, VMD, and other relevant regulatory agencies;

Interaction with Key Opinion Leaders (KOLs) and other experts in the exploration or advancement of development drug candidates
Earnings: Not provided at this time
Minimum Years of Experience: +5
Travel: up to 30%
Minimum Degree: DVM

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