Senior Project Scientist, Clinical Development

Huvepharma; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Huvepharma in the United States is seeking a Senior Project Scientist of Clinical Development to lead pre-approval studies and strategic planning for INAD/NADA and JINAD/ANADA approvals in livestock.

The role requires MS/PhD/DVM in a relevant field, 5+ years of GxP clinical experience, and strong regulatory affairs knowledge to interact with FDA/CVM and CROs.

You will manage timelines, budgets, and cross-functional teams, delivering high-quality data and reports for regulatory submissions.

Qualifications

• MS, PhD or DVM in animal sciences or veterinary medicine; advanced degree desirable.
• 5+ years of clinical experience with livestock (ruminants, swine, poultry).
• Experience executing GxP clinical activities in the animal health industry.
• Experience with development timelines and budgets desirable.
• Regulatory Affairs experience with FDA/CVM desirable.

Responsibilities

• Lead clinical activities for pharmaceutical projects across livestock species.
• Generate and maintain project development plans, timelines, and budgets.
• Ensure activities comply with FDA/CVM regulations.
• Design clinical studies, draft protocols, execute per GCP/GLP, analyze data, draft reports.
• Coordinate with CROs to execute studies.
• Engage with FDA/CVM as needed.
• Collaborate with internal/external partners on analytical requirements.
• Develop strategic plans for future development projects.
• Identify and evaluate new product and business opportunities.
• Build external partnerships to enhance collaborations.

Skills

GxP clinical activities

Regulatory Affairs

Leadership

Cross-functional collaboration

Project management

Data analysis

Clinical study design

Communication

FDA/CVM liaison

Strategic planning

Education

MS/PhD or DVM in animal sciences or veterinary medicine

Job description

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.