Senior Clinical Pharmacologist

Senior Clinical Pharmacologist As a Senior Clinical Pharmacologist, this individual is expected to plan, design, implement and analyze in‑vivo and in‑vitro pharmacokinetic and pharmacodynamic (PK/PD) studies, working with Clinical Pharmacology, Quantitative Pharmacology, Pharmacometrics/Pharmacodynamics (PK/PD), Toxicology, Bioanalytical, Therapeutic Focus areas and Clinical Development/Regulatory Affairs teams. The role contributes to the scientific understanding of PK/PD for assigned projects through quantitative evaluation of the pharmacokinetic and pharmacodynamic profile for research programs, applying state‑of‑the‑art knowledge in pharmacokinetics and pharmacodynamics. Day in the Life Plans, designs, implements and analyzes routine Pharmacometrics (PMx) studies to advance scientific knowledge, in collaboration with other team members. Performs analyses such as NCA, compartmental modeling, PopPK, translational modelling, disease modelling, Pop PK/PD, E‑R analyses (or works closely with the Research Specialist or PMx Stats Programming team) to deliver PMx results, interpretation and discussion. Works (or collaborates with Research Specialist or Programming team) to prepare TFLs to support IND/CTA, PK WSs, Tox WS, Pharm WS, CSRs, DSURs, IB and other documents. Collaborates with Scientific Writing (and where appropriate with the PMx Stats Programming team) to ensure TFLs for PMx reports are complete, and works in conjunction with Scientific Writing, QC and QAA (as required) to issue study reports in support of IND/CTA submissions and other regulatory documents. With close supervision from senior PMx staff, supports preparation of material to be used in regulatory interactions. Contributes to preparation of PMx materials for regulatory background packages, e.g., for pre‑IND, EOP2 and pre‑BLA meetings. Has understanding of advanced PMx concepts and techniques, such as advanced pharmacokinetics, advanced pharmacological principles, non‑compartmental analysis methods, Exposure‑Response analysis methods, translational modelling/pharmacology, Nonlinear Mixed Effects modelling, logistic regression, survival analysis, Bayesian approaches, disease modelling/QSP. Is highly skilled in the use of relevant software, including MS‑Excel, R, R‑Studio, Prism, Phoenix WinNonlin, NLME, STAN and Non-Mem, working in the department computing environment to perform advanced PMx analyses. Qualifications Serve independently as study CP/QP/PPKPD lead for moderately complex studies. Support study CP/QP/PPKPD lead for more complex studies and contribute to or lead non‑project objectives. Communicate effectively with and influence team members from other functions. Fully understand processes and represent PMx on process initiatives. Begin establishing own research areas within development sciences. Required Experience A PhD in Biology, Pharmacology, Engineering or a Pharmacy (Pharm.D.), Medicine (MD) degree and at least 3+ years of relevant Clinical Pharmacology experience. Salary Salary range: $128,600.00 – $210,000.00 per year. EEO Statement 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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business. #J-18808-Ljbffr Regeneron Pharmaceuticals, Inc