Director, Midwest Clinical Center

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Director, Midwest Clinical Center

Description

Legal responsibility and overall administrative responsibility for operating the Clinical Center in Fulton MO - the site is staffed with over 50 BI AH employees (Clinical scientists, biologists, monitors, animal caretakers and other technical and administrative staff) responsible for designing and conducting clinical studies required in Animal Health Research and Development. Directs staff and allocation of resources for the rearing and maintenance of challenge materials (parasites and other agents) and proper animal care ' welfare for several different species (mice, rabbits, cats, dogs, sheep, pigs, cattle and horses). Ensures compliance with applicable local, international and BI internal regulations with regard to operations of the MRC site and also 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. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities

• Directs operational and administrative activities at the Midwest Clinical Site. Responsible for the effective functioning of the site including compliant and state-of-the-art animal facilities, parasitology and analytical laboratories, construction and maintenance activities and the field territory (~900 acres) within the agreed budget including budget planning and management of Capital and maintenance projects.
• Develops strategic and technical partnerships with Clinical staff for the development of animal models and the conduct of preclinical research, target animal safety, efficacy, food residue and environmental risk programs for assigned Animal Health Innovation Division projects.
• Directs personnel ensuring the care and welfare of research animals used at the site.
• Ensures and provides effective infrastructure support for the site. Drive and ensure progress of planning and execution to meet long-term and strategic infrastructure needs.
• Ensures compliance in the area of Environment Health and Safety (EHS), Biosafety ' Biosecurity, GxP, Pharmacovigilance, Animal Welfare, workers safety and local labor laws.
• Provide overall management, standards, and procedures for all site activities and for exempt and non-exempt personnel.
• Trains, coaches, encourages, develops, leads, recruits and retains staff members according to Talent Management and creates an environment that promotes Agility, Accountability and Intrapreneurship.
• 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.
• Ensures and promotes compliance with relevant Environmental Health ' Safety (EHS), Biosafety ' Biosecurity, Regulatory, GLP, GCP, GXP standards as well as with local labor laws and BI Policies, Procedures and Guidelines.
• Acts at all times according to industry and BI standards and ethics (BI Code of Conduct, Leitbild) and ensures adherence to appropriate standards related to animal welfare.
• Acts as Sponsor Representative for clinical laboratory studies as necessary (GCP)
• Acts as Test Facility Manager for GLP studies run at the site
• Responsible for supporting and providing resources for studies to be run at the site, including the development of animal models, rearing and maintenance of challenge materials (parasites and other agents), procurement of animals and supplies, etc.

Requirements

• A recognized Veterinary Degree from an accredited institution is required with a minimum of ten (10) years of experience in veterinary research and development.
• In lieu of a Veterinary Degree, a Research-based Degree from an accredited institution with a minimum of fifteen (15) years of experience in veterinary research and development.
• Skill manager with extensive experience, ten-plus (10+) years, in animal health research ' development including regulatory requirements and/or in-depth technical expertise in specific fields (e.g. Parasitology, Animal Science, Animal Husbandry, Veterinary Medicine, Immunology, etc.).
• Experience in managing diverse technical and scientific personnel in an international and cross-functional matrix environment
• Experience in managing an R&D site.
• Extended experience in management of R&D facilities including a solid understanding of relevant regulations on Environment, Health ' Safety (EHS), Biosafety, Biosecurity, local labor laws, Animal Welfare, Laboratory regulations, Animal Husbandry.
• Proven ability to manage and develop high performing teams capable of operating and delivering in a complex regulated international matrix organization.
• Good working knowledge of guidelines applicable to safety and efficacy studies (FDA/CVM, EPA/FIFRA, USDA, MAFF, VICH, etc.)
• 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 (in particular 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.
• Willingness to travel.

Desired Experience, Skills, and Abilities:

• Additional language skills (German, French) advantageous

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