Senior Scientist Drug Safety & Metabolism

MSD • Rahway, NJ

1d • Hybrid

About The Position

The Senior Scientist, Drug Safety and Metabolism, is part of the Global Preclinical Development team in Rahway, New Jersey. Working under the supervision and leadership of assigned study leads in Preclinical Development-US, the scientist participates in multiple study teams and assists with the design, coordination, monitoring, and reporting of in vivo safety studies for companion animals and/or residue studies for livestock veterinary small-molecule pharmaceuticals. These studies support regulatory approval by global health authorities and must be conducted in accordance with Good Laboratory Practice (GLP) regulations and applicable guidance.

The role includes visiting contract research organizations (CROs) to observe critical study phases, quality-control review, generating and preparing raw data/XML files, and producing submission-ready packages for global health authorities, especially the US FDA. The scientist assists study leads in meeting study objectives and timelines, developing protocols and data capture forms, identifying CROs, preparing contracts, conducting pre-study discussions and monitoring visits, collecting and reviewing study documentation, and tracking study activities.

The incumbent monitors and reviews raw data and study documentation to ensure data quality and integrity, develops expertise in CVM submission data-quality requirements, and serves as a point person for organizing and assembling global and US-only submissions for Preclinical Development. The scientist also reviews study-phase and final reports for completeness against protocols, amendments, deviations, SOPs, OECD requirements, and GLP guidelines; assists with finalizing reports and regulatory submission packages; and helps transfer completed packages to the archivist or other document depositor.

Requirements

• Bachelor of Science degree and at least four years of experience in veterinary sciences, toxicology/pharmacology, pharmacokinetics, biology, chemistry, biochemistry, or an equivalent field.
• Recent experience within the last three years conducting and/or monitoring in vivo preclinical safety studies supporting registration of veterinary or companion-animal pharmaceuticals in an industrial setting or CRO.
• Experience preparing and/or obtaining solid scientific reports from CROs.
• Experience with Good Laboratory Practices (GLPs).
• Excellent verbal and written communication skills and strong attention to detail.
• Strong interpersonal skills and ability to work as a team member.
• Ability to multitask, manage competing priorities, deliver work within established timelines, and adapt to rapidly shifting priorities.
• Knowledge of standard office software such as Microsoft Word, Excel, PowerPoint, and SharePoint.
• Skills listed include automated liquid handling systems, bioanalytical method development, bioanalytical techniques, clinical judgment, data analysis, experimentation, flow cytometry, immunohistochemistry (IHC), research proposal development, scientific writing, teamwork, and tissue culture techniques.

Nice To Haves

• Working understanding of domestic and international regulations and guidance governing veterinary drug development for companion and food animals.
• Knowledge of electronic data capture systems and submission package preparation.
• Experience conducting, monitoring, reviewing, and/or summarizing residue and safety studies supporting domestic and international registration of veterinary pharmaceuticals.

Responsibilities

• Assist with the design, coordination, monitoring, and reporting of in vivo safety studies for companion animals and/or residue studies for livestock veterinary small-molecule pharmaceuticals.
• Work with assigned study leads to help ensure successful study outcomes and meet study timelines.
• Lead generation of raw data packages and subsequent submission-ready reports or packages.
• Participate in creating study protocols and data capture forms.
• Work with study leads to identify potential CROs and, as appropriate, assist with preparing study contracts.
• Participate in pre-study meetings or discussions involving protocol review and training, and conduct or participate in monitoring visits as appropriate.
• Collect, review, and monitor study documentation; prepare monitoring visit reports and provide them to the study lead when the incumbent conducts monitoring.
• Communicate regularly with study leads and help track study-related activities.
• Thoroughly monitor and review raw data and study documentation to ensure high data quality and integrity.
• Develop expertise in reviewing raw data to meet CVM submission requirements and organize and assemble global and US-only submissions for Preclinical Development.
• Review study-phase and final reports for completeness against protocols, amendments, deviations, SOPs, OECD guidance, and GLP guidelines.
• Assist study leads in reviewing and finalizing study reports and preparing study packages for regulatory submissions.
• Work with the study lead to transfer study packages to the archivist or other document depositor.
• Travel to CROs to observe critical study phases.

Benefits

• Medical, dental, vision healthcare, and other insurance benefits for employees and family.
• Retirement benefits, including a 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Eligible for an annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior