PK Study Monitor

Role Description

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 addition this position will review pharmacokinetic protocols and ensure full compliance with animal use protocols.

Responsibilities:

• Work collaboratively with multidisciplinary teams to coordinate non-GLP and GLP pharmacokinetic studies internally and at contract research organizations (CROs). In addition 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.
• Position requires travel to study sites up to 5-10% of time.
• Hybrid position working on site at least 50% in Kalamazoo and from home is possible.

Minimum skills education attributes:

• 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.
• Other attributes: self-motivation high quality standards attention to detail judgment flexibility planning problem solving and adaptability.

Desirable skills education attributes:

• 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.

Full time

Regular

Colleague

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