Senior Project Scientist, Clinical Development

The Senior Project Scientist of Clinical Development is responsible for leading and executing pre-approval clinical development studies and activities. This person will be responsible for strategic planning, organization, and execution of studies required for INAD/NADA and JINAD/ANADA approvals in livestock. In addition, this person will contribute to FDA/CVM regulatory compliance and negotiations for new livestock product approval.

EDUCATION & EXPERIENCE:

• MS, PhD or DVM in animal sciences, veterinary medicine or related field. An advanced degree desirable.
• Must have clinical experience with livestock (ruminants, swine and/or poultry)
• Must have 5+ years of experience of executing GxP clinical activities within the animal health industry
• Experienced at developing development timelines and budgets is desirable
• Regulatory Affairs experience with FDA/CVM desirable

TECHNICAL SKILLS REQUIREMENTS

• Advanced understanding of FDA/CVM requirements for pharmaceutical development in livestock.
• Experience in designing and executing effectiveness, safety (target animal and human food safety), and bioequivalence studies.
• Demonstrated proficiency writing protocols and study reports for submission to FDA/CVM.
• Experience in working with Contract Research Organizations (CRO) to execute clinical studies.
• Knowledge and ability to analyze complex data and make good technical and business decisions based on this analysis.
• Ability and experience at leading and managing multiple projects simultaneously.
• Proficiency at acting strategically to align with technical and business needs.
• Ability to work effectively and communicate effectively with departments outside R&D and regulatory such as commercial and quality.
• Excellent verbal and written communication skills.
• Ability and experience delivering project updates to senior leadership.

PHYSICAL REQUIREMENTS:

Ability to safely and effectively perform the essential job functions consistent with the ADA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards.

Must be able to drive an automobile.
Travel will be required (up to 50%)

POSITION RESPONSIBILITIES:

• Assumes leadership of clinical activities for various pharmaceutical projects across all livestock species.
• Responsible for generation and maintenance of project development plans, timeline, and budget.
• Ensure all project activities are compliant with FDA/CVM regulations.
• Design clinical studies, draft protocols, execute studies per regulatory requirements (GCP, GLP), coordinate analytical and statistical analyses, draft final study reports, and prepare data and results for submission to FDA/CVM that are compliant with regulatory agency expectations.
• Effectively utilize internal resources to deliver project milestones and timelines within established budget.
• Manage study activities conducted at contract research organizations.
• Engages directly with FDA/CVM on behalf of the company as needed.
• Collaborate with internal and external partners to ensure all analytical requirements (e.g. feed and plasma assay methods) are met for clinical studies.
• Works closely with project teams to develop strategic plans for future development projects.
• Work across the organization to identify and evaluate new product and business development opportunities.
• Establishes and develops relationships with external parties that may enhance our collaborations and partnerships.