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 livestock. In 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

 

 

Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.

Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.

 

 

Notice: Zoetis Recruiters will contact candidates via email from an address ending in @zoetis.com and may also initially connect with candidates through LinkedIn, including LinkedIn InMail. Zoetis does not use Gmail, Outlook, Yahoo, or other web-based/generic email domains to communicate about job opportunities, interviews, or offers of employment. If you receive a recruitment-related email message claiming to be from Zoetis that does not come from @zoetis.com, please treat it as suspicious. For your security, do not reply, click links, open attachments, share personal or financial information, or send money in response to unexpected or questionable recruitment communications.

 

 

Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at zoetiscolleagueservices@zoetis.com to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.