Senior Scientist Drug Safety & Metabolism

Brief description of major activities and the scope of the job e.g. supervisory responsibilities and scientific decision making and authority, e.g. generating and evaluating data).

The Senior Scientist, Drug Safety and Metabolism, is part of Global Preclinical Development team in Rahway, NJ. The ideal candidate will participate as a member of multiple study teams working under the supervision/leadership of the assigned study lead in Preclinical Development (PCD)-US. He/She will be required to assist in the design, coordination, monitoring, and reporting of in vivo safety studies for companion animals and/or residue studies for livestock veterinary small molecule pharmaceuticals to obtain regulatory approval from various global health authorities.

The position requires study conduct in accordance with Good Laboratory Practice (GLP) regulations and applicable regulatory guidance documents. Additional aspects incumbent to the role include travel to CROs to observe critical phases, Quality Control (QC) review, raw data/XML file generation/preparation, and generation of submission-ready packages to global health authorities, especially the US FDA.

(Brief description of major activities and the scope of the job e.g. supervisory responsibilities and scientific decision making and authority, e.g. generating and evaluating data). The Senior Scientist, Drug Safety and Metabolism, is part of Global Preclinical Development team in Rahway, NJ. The ideal candidate will participate as a member of multiple study teams working under the supervision/leadership of the assigned study lead in Preclinical Development (PCD)-US.

He/She will be required to assist in the design, coordination, monitoring, and reporting of in vivo safety studies for companion animals and/or residue studies for livestock veterinary small molecule pharmaceuticals to obtain regulatory approval from various global health authorities.

The position requires study conduct in accordance with Good Laboratory Practice (GLP) regulations and applicable regulatory guidance documents. Additional aspects incumbent to the role include travel to CROs to observe critical phases, Quality Control (QC) review, raw data/XML file generation/preparation, and generation of submission-ready packages to global health authorities, especially the US FDA.

• Familiarity with and ability to work under applicable departmental SOPs, regulations, and guidelines (VICH/GLP [21
  
  CFR
  58 or OECD]).
• Assist study leads to ensure all necessary actions are taken for a successful study outcome and study timelines are met.
• Lead generation of raw data package and subsequent submission-ready report(s)/package.

• Participate in the creation of study protocols and data capture forms.
• Work with the study lead to identify potential CROs to conduct study.
• Assist the study lead in the preparation of study contracts, as appropriate.

• Conduct and/or participate in pre-study meeting(s) or discussions which involve protocol review/training and study monitoring visits, as appropriate, to ensure CRO compliance with the protocol and relevant regulations/guidelines.
• Collect, review, and monitor study documentation.
• Prepare monitoring visit reports and provide them to study lead (if monitored by incumbent).
• Communicate regularly with the study lead and assist study lead in tracking all study-related activities.

• Ensure high quality data by thorough monitoring/reviewing of raw data and study documentation. Specifically, develop expertise needed to address CVM’s data quality/integrity component as regards submissions, via training on review of raw data in line with CVM’s requirements, and be the point person to organize and assemble global and US-only submissions for PCD.
• In addition to review of raw data, review study phase reports and final reports for completeness against the study protocol, amendments, deviations, SOPs, OECD, and GLP guidelines.

• Assist study lead in reviewing and finalizing study reports.
• Assist in the preparation of the study package for regulatory submission to current quality/data integrity standards.
• Work with the study lead to transfer the study package to the archivist or other document depositor.

• Bachelor of Science with at least four (4) years of experience in veterinary sciences, toxicology/pharmacology, pharmacokinetics, biology, chemistry, biochemistry, or…