We offer a wide range of toxicity and drug metabolism and pharmacokinetics (DMPK) studies, as well as other preclinical safety tests that are essential for preclinical drug development programs. With multiple test species available, studies are overseen by Study Directors with vast experience based on thousands of studies conducted for pharmaceutical and biotechnology companies across many disease therapies, thus ensuring quality performance, delivery of high-quality data, and proper interpretation, review and reporting of every aspect of our clients' studies.
location: Newark, Delaware
job type: Permanent
salary: $70,000 - 80,000 per year
work hours: 9 to 5
- Independently understand, recognize and generate draft and final study protocols and SOPs in Toxicokinetics analysis.
- Serving as a Principal Investigator on toxicokinetics studies, you will interact with Study Directors /Program Managers and Sponsors to perform TK methods/strategies on a regular basis as a primary point person.
- Coordinate TK phase of the study in conjunction with appropriate departments and across sites, as well as on bioanalytical data provided by Sponsors.
- Conduct TK/PK analysis using Phoenix WinNonlin software
- Generate high-quality TK/PK reports that comply with regulatory submissions.
- Supervise, train and/or mentor junior scientists as needed.
- Provide input to management on business needs and development opportunities
- Prepare materials for presentations and publications.
- Ph.D. degree (1- 3 years experience), MS degree (6+ years experience), BS degree (9+ years experience)
- Clear understanding of Bioanalytical data and validation as applied to Toxicological/ Pharmacokinetic (TK/PK) sample analysis.
- Must be proficient in Phoenix WinNonlin software.
- Must have experience in TK/PK data analysis and report writing.
- Demonstrated supervisory and managerial ability.
- Demonstrated knowledge of GLP regulations.
- Must have excellent oral and written communication skills.
- Ability to manage multiple priorities while maintaining the time lines.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.