Senior Clinical Pharmacologist
Regeneron
Senior Clinical PharmacologistBuild our future together. This individual is expected to plan, design, implement and analyze in-vivo and in-vitro pharmacokinetic & pharmacodynamic studies working with Clinical Pharmacology, Quantitative Pharmacology, Pharmacometrics/Pharmacodynamics (PK/PD), Toxicology, Bioanalytical, Therapeutic Focus areas and Clinical Development / Regulatory Affairs teams.This individual contributes to the scientific understanding of PK/PD for assigned projects, based on quantitative evaluation of the pharmacokinetic and pharmacodynamic profile for research programs, through the application of state-of-the-art knowledge in pharmacokinetics and pharmacodynamics.Work location: Tarrytown, NY, Warren, NJ or Cambridge, MAWork model/flexibility: 4 days per week on siteDiscover your role:Plans, designs, implements and analyzes routine Pharmacometrics (PMx) studies to advance scientific knowledge, in collaboration with other team members.Performs analyses such as compartmental modeling, PopPK, translational modeling, disease modeling, Pop PK/PD, E-R analyses (or work closely with Research Specialist or Pharmacometrics Stats Programming team) to deliver Pharmacometrics results, interpretation and discussion.Collaborates with Scientific Writing (and where appropriate with Pharmacometrics Stats Programming team) to ensure TFLs for Pharmacometrics reports are complete. Works in conjunction with Scientific Writing, Quality Control and QAA (as required) to issue study reports in support of IND/CTA submissions and other regulatory documents.With close supervision from senior Pharmacometrics staff, supports preparation of material to be used in regulatory interactions.Contributes to preparation of Pharmacometrics materials for regulatory background packages, e.g. for pre-IND, EOP2, and pre-BLA meetings.This role requires:A PhD in Biology, Pharmacology, Engineering or a Pharmacy (Pharm.D.), Medicine (MD) degree and at least 3+ years of relevant Clinical Pharmacology experience.Are able to serve independently as study Clinical Pharmacology/Quantitative Pharmacology/PPKPD lead for moderately complexIs highly skilled in use of relevant software, including MS-Excel, R, R-Studio, Prism, Phoenix WinNonlin, NLME, STAN and NonMem, working in department computing environment to perform advanced PMx analyses.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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.
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