We are looking for a Senor R&D Specialist in the Preclinical Pharmacokinetics and Pharmacodynamics (PPKPD) Group. The Sr Specialist will contribute to the protocol design/input for all Pharmacokinetics/ Toxicokinetics studies & conduct data analysis using Win NonLin and other similar programs/analysis software. This person will work with the pre/nonclinical immunoassay group to ensure transparency of data transfer/sharing and will follow all SOPs to ensure GLP compliance.
A day in the life of the Sr Specialist may look like:
- Performs non-compartmental PK and compartmental PK/PD analyses, according to GxP as appropriate.
- Performs Nonlinear Mixed Effects modeling and simulation analyses (or other modeling efforts) as appropriate.
- Performs other descriptive analyses for study reports and publications as applicable
- Provide PK data analysis to support BLA Filings
- Independently carries out broad array of work supporting department priorities in routine Pharmacometrics deliverables on study design, analysis and reporting.
- Support CRO Studies, track study DS/DP requirements and track project priorities for the group
- Maintains a compliant work environment by staying current with SOPs and being up-to-date with existing GLP guidelines.
This may be the job for you if:
- Have good time management skills to ensure that key data is turned around to meet critical deadlines
- Have strong communication skills, making sure that key issues are brought to the attention of their supervisor
- Enjoy having worked in a GLP environment and following SOPs
This position requires a BS/MS degree and a minimum of 8+ years proven experience. This experience should include an understanding of pharmacokinetic concepts and techniques. We expect that you would be skilled in the use of relevant software, including Phoenix WinNonLin and NLME. Experience in animal PK/TK studies, including protocol design & study conduct is highly desirable.
You should be able to clearly describe and perform sophisticated pharmacometric techniques and interpret results.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
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