Senior Product Development Manager
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Job Description
Senior Product Development Manager overseeing veterinary drug development and clinical research at Argenta. Managing projects from pre-clinical to clinical phases while ensuring compliance with regulations.
Responsibilities:
- Supports the Americas CRO business (regulatory to pre-clinical to clinical service) needs of Argenta Molecule to Market, and Risk/Mitigation plans
- Effectively manage the product development requirements (pre-clinical and clinical projects) of internal and external projects
- Demonstrates an awareness of current regulations, guidance's, and the animal drug development process, while maintaining a flexible and creative mindset to work through product development challenges.
- Contribute to the development of business strategies to increase profitability and grow the business to create value.
- Manage development projects or key development project areas from initial conversations to live-phase study activities to close-out / final study report signatures to tracking overall timelines and budgets for study activities.
- Coordinates selection of the vendor(s) for study protocol conduct &/or laboratory requirements and activities including the provision of necessary supplies required by the study protocol
- Provides oversight to ensure tasks are completed correctly and on time (i.e. oversight in the tracking of adverse events (AEs) encountered in the study and ensures that all serious AEs and non-serious AEs are communicated appropriately to the Sponsor)
- Coordinates the creation of materials and documentation for the study, and QA resources, as required
- Directs and provides oversight of investigational veterinary product/control product inventory, accountability, labelling, regulatory documentation/notifications, and shipment of drug supplies to/from the Sponsor and study sites
Requirements:
- 10+ years or greater in veterinary drug development
- Clinical Research Associate experience or equivalent experience and training
- Experience and skills necessary to monitor a study
- Results oriented. Defines and plans priorities well
- Effectively manage client and stakeholder expectations through relevant communication
- Comfortable balancing shifting priorities as required to meet business needs
- A collaborative working style to be able to lead and motivate people at all levels and across all functions in an organization
- Strong analytical thinking and problem-solving skills
- Capable of working in a changing environment and under pressure
- Effectively present information and concepts, in both written and oral formats clearly and concisely
- Actively listens to ensure understanding
- Computer proficiency including Outlook & Microsoft Suite and various assigned database platforms and electronic meeting applications
- Express facts and ideas in writing in a clear, concise, convincing, and organized manner
Benefits:
- strong culture
- great benefits
- opportunity for growth
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