Senior Scientist Drug Safety & Metabolism
About The Position
The Senior Scientist, Drug Safety and Metabolism, is part of the Global Preclinical Development team in Rahway, New Jersey. The role participates on multiple study teams under the supervision or leadership of an assigned Preclinical Development (PCD)-US study lead. The scientist assists with the design, coordination, monitoring, and reporting of in vivo safety studies for companion animals and residue studies for livestock veterinary small-molecule pharmaceuticals to support regulatory approvals from global health authorities. Studies must be conducted in accordance with Good Laboratory Practice (GLP) regulations and applicable regulatory guidance. The role also includes travel to contract research organizations (CROs) to observe critical study phases, quality control review, raw data/XML file generation and preparation, and creation of submission-ready packages for global health authorities, particularly the US FDA. The scientist works under applicable departmental SOPs, regulations, and guidelines, including VICH/GLP (21 CFR 58 or OECD). They assist study leads in ensuring study actions and timelines are met, lead generation of raw data packages and submission-ready reports or packages, and contribute to study planning, conduct, data review, reporting, and regulatory submission preparation. The position is hybrid and requires approximately 10% travel.
Requirements
- Bachelor of Science 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.
- Team-player attitude and strong interpersonal skills.
- Ability to multitask, manage competing priorities, deliver work within established timelines, and adapt to rapidly shifting priorities.
- Knowledge of standard computer software for general office work, such as Microsoft Word, Excel, PowerPoint, and SharePoint.
- Data analysis, research proposal development, scientific writing, and teamwork skills.
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 study leads in ensuring necessary actions are taken for successful study outcomes and that study timelines are met.
- 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 in preparing study contracts.
- Participate in pre-study meetings or discussions involving protocol review and training, and conduct study monitoring visits as appropriate to ensure CRO compliance with protocols and applicable regulations and guidelines.
- Collect, review, and monitor study documentation.
- Prepare monitoring visit reports and provide them to the study lead when monitoring the study.
- Communicate regularly with the study lead and help track study-related activities.
- Monitor and review raw data and study documentation to ensure high data quality and integrity, including organizing and assembling global and US-only submissions for PCD.
- Review study phase and final reports for completeness against protocols, amendments, deviations, SOPs, OECD guidelines, and GLP guidelines.
- Assist the study lead in reviewing and finalizing study reports.
- Assist in preparing study packages for regulatory submission in accordance with current quality and data-integrity standards.
- Work with the study lead to transfer study packages to the archivist or another document depositor.
- Travel to CROs to observe critical study phases as needed.
Benefits
- Medical, dental, vision healthcare, and other insurance benefits for employees and family.
- Retirement benefits, including 401(k).
- Paid holidays, vacation, and compassionate and sick days.
- Annual bonus and long-term incentive, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
