Argenta

Clinical Research

• Obtains a clear understanding of all aspects of the study and defines roles of study personnel
• Collaborates with the sponsor to establish projected study timelines for the study
• Provides detailed oversight to ensure tasks are completed correctly and on time

Senior Clinical Trial Manager

Compliance

• Facilitates and supports the regulatory and drug development requirements of external clients and internal projects
• Effectively manage client and stakeholder expectations by providing timely, relevant, and accurate documents, assessments, reports and communications
• Demonstrates an awareness of current regulations, guidance's, regulatory processes, and the animal drug development process, while maintaining a flexible and creative mindset to work through regulatory challenges
• Creates regulatory solutions to complex issues
• Provides client accurate expert regulatory advice on animal health product development
• Represent Argenta in industry associations (e.g. GADA, AHI, SQA)
• Identify and pursue new regulatory consulting opportunities which may include meeting with new clients, traveling and speaking at professional meetings, networking in the industry and contributing to various publications

Senior Regulatory Affairs Manager

Product Manager

• 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

Senior Product Development Manager

Business Development Rep

• Maintain current client relationships and identify areas for potential clients
• Contacting potential clients to establish a business relationship
• Develop the CDO sales area, improve sales and win rates
• Research the latest trends in animal health and identify most likely areas for business expansion
• Develop a strong understanding of company products and intellectual property to drive sales
• Lead preparation, negotiation, and closure of high quality proposals
• Ability to work closely with marketing agency and technical staff to promote science and execution

Senior Clinical Trial Manager

Senior Regulatory Affairs Manager

Senior Product Development Manager

Business Development Manager