Senior Clinical Manager, Research & Development

Huvepharma; Lincoln (NE); Presencial; USD 130.000 - 195.000; Jornada completa

Descripción de la vacante

Huvepharma in Lincoln, Nebraska seeks a Senior Clinical Manager, R&D to lead planning, design, and execution of animal health clinical studies and regulatory submissions. You will guide the Clinical R&D team, ensure compliance with USDA-CVB requirements, and coordinate with Regulatory Affairs and other functions to advance product development.

The role requires a DVM and 5–7 years of relevant experience in animal health clinical research, with strong leadership in multidisciplinary teams and

Formación

• DVM is required; veterinary medical judgment is essential to the role.
• 5–7 years of relevant experience in animal health clinical research or product development.
• Proven leadership of clinical research programs and multidisciplinary teams.
• Experience designing and interpreting clinical studies for regulatory submissions.

Responsabilidades

• Leads and oversees clinical research activities across multiple species to support R&D and regulatory submissions.
• Directs planning, design, execution, monitoring, and reporting of clinical studies.
• Collaborates with Regulatory Affairs and other R&D leaders on study protocols and project plans.
• Ensures compliance with USDA-CVB requirements and quality/regulatory standards.
• Develops and manages the Clinical R&D team in Lincoln, focusing on capability building and resource allocation.
• Oversees external CROs, investigators, and collaborators, including study planning and reporting.
• Reviews study data and reports for scientific integrity and regulatory suitability.
• Identifies risks and implements corrective actions to maintain progress and compliance.
• Engages with cross-functional teams to support product development and regulatory approval.

Conocimientos

Clinical leadership

Regulatory submissions

Cross-functional collaboration

Project management

Quality systems

Educación

DVM

Descripción del empleo

The Senior Clinical Manager, R&D is responsible for leading the planning, design, execution, and oversight of clinical research activities supporting the development, evaluation, and regulatory approval of animal health biological products across multiple species. This position provides scientific and operational leadership to the Clinical R&D team based in Lincoln, Nebraska, ensuring clinical studies are conducted efficiently, in compliance with applicable regulatory requirements, and in alignment with organizational priorities. The role collaborates cross-functionally with Regulatory Affairs, R&D, Quality, Manufacturing, and external research partners to advance product development initiatives and achieve project objectives.

EDUCATION & EXPERIENCE:

• Doctor of Veterinary Medicine (DVM) required. Retain if veterinary medical judgment is essential to the role.
• Minimum of 5-7 years of relevant experience in animal health clinical research, product development, or a closely related scientific discipline, preferably within the animal health industry.
• Demonstrated experience leading clinical research programs and managing multidisciplinary scientific teams.
• Experience designing, conducting, and interpreting clinical studies supporting regulatory submissions.
• Demonstrated knowledge of USDA-CVB requirements and the regulatory approval process for veterinary biological products.
• Experience with poultry and swine clinical research required; experience across additional livestock species preferred.

TECHNICAL SKILLS REQUIREMENTS:

• Doctor of Veterinary Medicine (DVM) required. Retain if veterinary medical judgment is essential to the role.
• Minimum of 5-7 years of relevant experience in animal health clinical research, product development, or a closely related scientific discipline, preferably within the animal health industry.
• Demonstrated experience leading clinical research programs and managing multidisciplinary scientific teams.
• Experience designing, conducting, and interpreting clinical studies supporting regulatory submissions.
• Demonstrated knowledge of USDA-CVB requirements and the regulatory approval process for veterinary biological products.
• Experience with poultry and swine clinical research required; experience across additional livestock species preferred.

POSITION RESPONSIBILITIES:

• Leads and oversees clinical research activities supporting R&D Biologicals across multiple species, ensuring effective utilization of internal and external resources to achieve project objectives and timelines.
• Directs the planning, design, execution, monitoring, and reporting of clinical studies to support product development, regulatory submissions, and licensure.
• Collaborates with Regulatory Affairs and other R&D leaders to develop clinical research strategies, study protocols, and project plans aligned with organizational priorities and regulatory requirements.
• Ensures clinical studies are conducted in accordance with applicable USDA-CVB requirements, established protocols, internal procedures, and relevant quality and regulatory standards.
• Leads and develops the Clinical R&D team based in Lincoln, including resource allocation, performance management, employee development, and continuous improvement of team capabilities.
• Establishes clinical study priorities, manages competing project demands, and monitors study progress to ensure timely achievement of research and development milestones.
• Oversees external contract research organizations, investigators, and research collaborators, including study planning, protocol development, execution, data quality, and final reporting.
• Reviews and evaluates clinical study data, protocols, and reports to ensure scientific integrity, accuracy, and suitability for regulatory submissions and business decisions.
• Identifies and addresses clinical study risks, technical challenges, and resource constraints, implementing appropriate corrective actions to maintain project progress and compliance.
• Collaborates with cross-functional teams, including Regulatory Affairs, Quality, Manufacturing, and other R&D functions, to support product development and regulatory approval activities.
• Provides clinical research expertise and project updates to senior leadership, including recommendations regarding study design, project feasibility, resource requirements, and development priorities.
• Supports the evaluation of new research opportunities, external collaborations, and potential product development initiatives that contribute to the company’s R&D pipeline.
• Establishes and maintains productive relationships with external research organizations, academic institutions, and industry partners to support current and future research initiatives.
• Participates in the evaluation of scientific publications, patent applications, and technical due diligence activities, as needed.
• Collaborates with the Regulatory Pharma team to support pharmaceutical clinical research activities, as needed.