Senior Associate Scientist/Scientist - Study Coordinator

States considered: all states considered however the position is on site in Kalamazoo, MI.

Role Description

Zoetis Veterinary Medicine Research and Development, Global Therapeutics in Kalamazoo, MI is seeking a Study Coordinator at the Sr. Associate Scientist/Scientist level. This role will work collaboratively with the Biomarker Working Group across multiple therapeutic areas to coordinate and monitor the logistics of biological samples from GXP and non-GXP studies and operationalize biomarker strategies spanning early to late-stage drug development. The successful candidate will closely collaborate with biomarker leads, biomarker laboratories, clinical trial operations, supply chain leads, non-clinical pharmacology and safety, data management, biospecimen sample lab, biomarker data scientists, and external laboratory vendors/contract research organizations (CROs).

Responsibilities:

* Partner with multidisciplinary project teams to forecast, plan, coordinate, monitor, and manage the logistics for GXP and non-GXP studies and biological specimen logistics internally and externally at CROs.

* Track study progress and provide regular updates to stakeholders, serving as the primary point of contact between stakeholders, partner lines, and team members.

* Work closely with internal partners such as digital biologists, data management, and central technical operations to establish appropriate metadata collection and sample tracking.

* Facilitate data entry/import/transfer from CROs into Zoetis databases; ensure data transformation and organization is accurate and usable for project analysis and decision-making; independently manage the transfer of data and study documentation between CROs and Zoetis.

* Draft as well as critically review study protocols, study reports, and analytical plans, and prepare documents to be signature ready.

* QC review non-clinical study results for completeness and in compliance with the study protocol, Zoetis SOPs, and applicable government regulations and guidelines.

Minimum skills, education, attributes:

* Bachelor's degree with 4 years or Master's degree with 2 years of experience in non-clinical development, diagnostics, and/or Pharmaceutical/Biotech R&D (or the equivalent combination of education and experience).

* Knowledge and understanding of general scientific principles as applied to research, development, and implementation.

* Strong organizational abilities coupled with the ability to manage multiple projects. Demonstrated skills in the organization of study samples, study logistics, and in vivo/biomarker analysis laboratory data.

* Familiarity with biospecimen collection and processing for biomarker analysis.

* Experience authoring technical documents and study reports and creating data tables for reporting.

* Familiarity with data collection and management software (LIMS) such as Watson

* Advanced skills with Microsoft Office (Word, Excel, Outlook) and overall comfort with computer systems.

* Strong attention to detail, excellent organizational skills, and interpersonal skills, as well as outstanding written and oral English communication skills.

* High level of self-motivation, high quality standards and attention to detail, strong judgment, exceptional problem-solving skills, ability to balance competing priorities tactfully, and the ability to be flexible and adaptable to work in a complex, dynamic, and global environment.

Desirable skills, education, attributes:

* Previous biomarker laboratory experience.

* Experience managing large data sets.

* Experience in pharmaceutical drug development

* GLP / GCP experience preferred. Knowledge of clinical/non-clinical study design and implementation.

* Knowledge of requirements of various global regulatory authorities, including FDA-CVM, VICH Guidelines, and GLPs governing the conduct of preclinical safety studies for development of veterinary pharmaceuticals.

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.