The Study Director/Staff Veterinarian, under the guidance of the Associate Director, In Vivo Pharmacology, will assume a pivotal role in leading in-vivo research initiatives while ensuring compliance with regulatory standards. This multifaceted position necessitates expertise in veterinary medicine, study design, and regulatory adherence. The incumbent will primarily oversee research projects, manage laboratory animal colonies, ensure animal welfare standards, maintain meticulous documentation, and facilitate effective communication within and across departments.

Key Responsibilities:

Study Leadership (50%)

• Serve as the primary Study Director/Principal Investigator for designated research projects.

• Develop, review, and endorse study protocols, amendments, and schedules adhering to regulatory guidelines and client specifications.

• Ensure strict adherence to protocols, SOPs, and pertinent regulatory standards throughout the study lifecycle.

• Act as the principal liaison for client communication, regulatory agencies, and internal departments.

• Lead pre-initiation meetings and other study-related discussions.

• Supervise the preparation and finalization of comprehensive study reports, ensuring accuracy and completeness.

• Manage study files, documenting correspondence, schedules, and protocol deviations.

• Provide timely and professional responses to audit reports and client inquiries.

Colony Management and Primary Care (30%)

• Oversee the management and care of laboratory animal colonies, ensuring compliance with AAALAC, USDA, and FDA regulations.

• Devise and implement robust health monitoring programs for research animals.

• Offer primary veterinary care and medical treatment to research animals as required.

• Monitor and uphold animal welfare standards, encompassing environmental enrichment and housing conditions.

• Collaborate with animal care staff to ensure adherence to proper husbandry practices and disease prevention measures.

Documentation and Record Keeping (5%)

• Generate and uphold high-quality study data in accordance with regulatory guidelines such as GLP, FDA, and ISO standards.

• Maintain accurate records of animal care, housing, and experimental procedures.

• Develop and interpret research protocols, ensuring alignment with GLP and EHS guidelines.

• Author, review, and update Standard Operating Procedures (SOPs) to standardize laboratory practices.

• Ensure prompt and accurate documentation in tracking systems, emphasizing EHS requirements.

• Prepare for and participate in regulatory inspections, ensuring inspection readiness and compliance with applicable regulations.

Communication and Collaboration (5%)

• Cultivate effective communication and collaboration within the research team and across functional areas.

• Serve as a liaison between the In Vivo Pharmacology department and other departments, ensuring smooth coordination of activities.

• Provide guidance and support to research teams on study design, execution, and compliance matters.

• Act as a member of the Institutional Animal Care and Use Committee (IACUC), ensuring ethical treatment of research animals and compliance with federal regulations.

Training and Development (5%)

• Design training programs for vivarium staff and research teams on vivarium scheduling and animal care.

• Provide technical leadership and expertise.

• Identify areas for improvement and deliver necessary training.

• Mentor staff, fostering a positive working environment and cross-cultural sensitivity.

• Continuously enhance skills and knowledge to augment contributions to vivarium operations.

Other Duties and Responsibilities as assigned (5%)

• May be tasked with additional duties as required.

Requirements:

Minimum Education and Experience:

• Doctor of Veterinary Medicine (DVM) degree from an accredited institution or currently in the process of completing last academic year.

• 3+ years of experience in laboratory animal science or preclinical research settings.

Preferred Education and Experience:

• Board certification or eligibility in laboratory animal medicine (ACLAM or equivalent).

• Previous experience as a Study Director or Principal Investigator in preclinical research studies.

• Familiarity with project management principles and practices.

• Proficiency in statistical analysis software (e.g., SAS, R) for data analysis and interpretation.