PK Study Monitor

Zoetis • Kalamazoo, MI

23h • Hybrid

About The Position

Zoetis Veterinary Medicine Research, Global Therapeutics in Kalamazoo, MI is seeking a study monitor. The successful candidate will support the operational needs of the pharmacokinetics partner line. This position will support work within a range of projects from early discovery through full development and post-approval for both large and small molecules, across therapeutic areas for companion animals and livestock. In addition, this position will review pharmacokinetic protocols and ensure full compliance with animal use protocols. Zoetis is a Fortune 500 company and the world leader in animal health, discovering, developing, manufacturing and commercializing vaccines, medicines, diagnostics and other technologies for companion animals and livestock. Their award-winning culture, built around their Core Beliefs, focuses on colleagues’ careers, connection and support.

Requirements

• Bachelors degree with 3 years in a biological science area, veterinary or livestock industry, research experience in the pharmaceutical industry, or a related field.
• Understanding of pharmacokinetic study designs.
• Demonstrated skills in organization and management of animal colonies, organization of study samples, study logistics, and in vivo set up.
• Experience maintaining IACUC protocols and amendments.
• Familiarity with data collection and management software as well as review of data both paper and electronic.
• Advanced skills with Microsoft Office tools and overall comfort with computer systems.
• Excellent organizational and interpersonal skills as well as outstanding written and oral English communication skills.
• Ability to work in a collaborative and dynamic team environment in a global company.
• Self-motivation.
• High quality standards.
• Attention to detail.
• Judgment.
• Flexibility.
• Planning.
• Problem solving.
• Adaptability.

Nice To Haves

• Previous experience in working in vivo research setting.
• Understanding of scientific principles and experimental study design.
• Familiarity with pharmacokinetic and bioanalytical laboratory data collection and management software (LIMS) such as Watson.
• Knowledge of requirements of various global regulatory authorities, including FDA-CVM, VICH Guidelines, Animal Welfare Act, USDA and GLPs governing the conduct of preclinical safety studies for development of veterinary pharmaceuticals.

Responsibilities

• Work collaboratively with multidisciplinary teams to coordinate non-GLP and GLP pharmacokinetic studies internally and at contract research organizations (CROs).
• Coordinate and monitor all the logistics and completion for the pharmacokinetic sample analysis for all studies (Non-Clinical).
• Serve as primary owner for animal use protocols (AUPs) that support all pharmacokinetic study work as well as oversight of all animals on pharmacokinetic AUPs.
• Act as liaison with IACUC, veterinarians, and study representatives for AUP duties.
• May author/co-author protocols, reports, and contribute to compiling supporting documents and data.
• Plan, oversee, and forecast animal colony size and utilization to meet pharmacokinetic study timelines for portfolio support.
• Implement and monitor animal colony management in coordination with veterinary staff and coordinators.
• Facilitate data entry/import/transfer from CROs or internal into Zoetis databases; independently manage transfer of study documentation between CROs and Zoetis.
• Serve as gatekeeper for documents and document management systems for PK partner line.

Benefits

• Competitive healthcare and retirement savings benefits.
• An array of benefits, policies and programs to support employee well-being in every sense, from health and financial wellness to family and lifestyle resources.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees