Director, Georgia Clinical R&D Center

The role of Director, Georgia Clinical R&D Center is a key position within the Clinical Site Network organization of Animal Health (AH), responsible for leadership, direction and overall legal accountability for operating the Colbert site in Georgia, USA and for the R&D team located on the site (consisting of scientists, animal caretakers, technical and administrative staff) responsible for designing and conducting clinical studies required in Animal Health Research and Development. The site also conducts Quality Control studies required for the release of vaccines manufactured in the BI AH Operations site located in Athens GA.

Together with the Clinical Site Network and the other Global Clinical Functions, the Director, Georgia Clinical R&D Center oversees clinical development for assigned projects and studies with focus on site effective resource management and planning for advancing projects according to approved priorities. As part of the Clinical Network, the incumbent promotes a culture across site collaboration, harmonization of standards, good practices, and operational excellence, as well as transparency regarding study capabilities and capacities. As such, the position holder contributes to the long-term CAPEX and OPEX definition of the network. Ensures and provides effective infrastructure support for the site in line with Network Global Master Plan.

• Directs staff and allocation of resources for the rearing and maintenance of challenge materials (parasites and other agents) rodent animal models and proper animal care & welfare for several different species (rodents, rabbits, cats, dogs, poultry sheep, pigs, cattle, and horses).
• Ensures compliance with applicable local, international, and BI internal regulations regarding operations of the Colbert site and in compliance matters related to certain studies conducted in the facility (GLP - Test Facility Management).
• Together with scientific directors, oversees assigned vaccine and pharmaceutical Innovation studies with focus on site effective resource management and planning for advancing projects according to approved priorities.
• Supports the development of animal models in conjunction with the scientific staff.
• Ensures efficient management and interaction of staff from all functions on site and from Global Supply.
• Directs operational and administrative activities at the Georgia Clinical R&D Site.
• Responsible for the effective functioning of the site including compliant and state-of-the-art animal facilities, laboratories, construction and maintenance activities and the field territory within the agreed budget including budget planning and management of Capital and maintenance projects.
• Together with the Clinical Site Network, Clinical Study Excellence, and Clinical Functional Capabilities, ensures participation into the transparent study allocation processes across the network to ensure visibility of the studies on-going on site, resources allocations, skills development, and adequate prioritization to address portfolio needs.
• Develops strategic and technical partnerships with Clinical staff for the development of animal models and the conduct of studies for assigned Animal Health Innovation Division projects.
• Directs personnel ensuring the care and welfare of research animals used at the site.
• Accountable for the veterinary care, preventative medicine, and health surveillance of research animals (production, companion, laboratory animals and poultry). This may include on-call coverage for weekends and holidays.
• Ensures and provides effective infrastructure support for the site.
• Drives and ensures progress of planning and execution to meet long-term and strategic infrastructure needs.
• Ensures compliance around Environment Health and Safety (EHS), Biosafety & Biosecurity, GxP, Pharmacovigilance, Animal Welfare, workers safety and local labor laws.
• Provides overall management, standards, and procedures for all site activities and for exempt and non-exempt personnel.
• Oversees and coordinates the animal procurement system for R&D and Quality Control in-house studies.
• Provides aid, when required, in procuring animals for off-site studies.
• Creates and fosters a culture that supports teamwork and collaboration within the global clinical organization as well as with other functions inside and outside of the Animal Health Innovation Division.
• Coaches, encourages, develops, leads, recruits, and retains high quality staff according to Talent Management and creates an environment that promotes agility, accountability, and intrapreneurship.
• Creates and fosters a culture founded on innovation, collaboration, high performance, trust and speak up.
• Encourages an atmosphere of new ideas and innovative thoughts and agile working.
• Focuses on overall development of teams skills that support corporate goals and objectives, and global cooperation.
• Ensures functional excellence of Clinical Operations staff through hiring, developing, and retaining key talent.

• A recognized Veterinary Degree or PhD level scientist with a minimum of ten (10) years of experience in veterinary research and development is required.
• Board certification or board eligibility in Laboratory Animal Medicine is a plus.
• For DVM, license (or eligibility) to practice veterinary medicine in Georgia is a plus.
• Skilled manager with experience in the research, development, and registration of animal health products.
• Experience in managing diverse technical and scientific personnel in an international and cross-functional matrix environment.
• Experience in managing an R&D site.
• Safety and compliance training in all aspects of HSE.
• Proven leadership, people development and management skills.
• Effective communicator with excellent negotiation and interpersonal skills and the ability to form productive working relationships at all levels across disciplines, cultures, and nationalities; experience negotiating externally with CROs and technology providers.
• Strong knowledge of US regulatory requirements for animal health products, and insight into what is required to support appropriate claim structure.
• Additional knowledge of requirements outside US (particularly EMA/CVMP) would be an advantage.
• Experience in planning, conducting, and reporting clinical studies to support preclinical research and early development of new APIs and formulations, as well as, to generate pivotal safety and efficacy data for new veterinary pharmaceutical products.
• Experience in developing new claims and uses for existing products.
• Experience in protocol development and study design, data management and processing, analysis, and collation to meet the goals of global development programs.
• Self-motivated decision maker with a high degree of initiative, commitment, and persistence and with well-developed organizational capabilities and good judgement skills.
• Excellent English verbal, written and presentation skills; additional language skills (German, French) advantageous.
• Willingness to travel.

Eligibility Requirements :

• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required).
• Must be 18 years of age or older.