Apply on Employer Site

Argenta · 12 hours ago

Senior Product Development Manager

United States

Full-time

Remote

Senior Level, Lead/Staff

10+ years exp

Argenta is a global team dedicated to healthier animals, seeking a Senior Product Development Manager to support their Americas CRO business. The role involves managing product development requirements, overseeing projects from initiation to completion, and ensuring compliance with regulations in veterinary drug development.

ManufacturingMedicalPharmaceuticalVeterinary

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

Qualification

Veterinary drug developmentClinical Research AssociateProject managementAnalytical thinkingProblem-solvingComputer proficiencyCommunication skillsCollaboration