Senior Clinical Pharmacologist

As a Senior Clinical Pharmacologist 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.

A day in the life may look like:

• 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 work closely with 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 PMx Stats Programming team) to ensure TFLs for PMx reports are complete. 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 modeling, logistic regression, survival analysis, Bayesian approaches, disease modelling/QSP.
• Is 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*.

This may be the right role for you if you:

• Are able to serve independently as study CP/QP/PPKPD lead for moderately complex studies or support study CP/QP/PPKPD lead for more complex studies, and to contribute to or lead non-project objectives.
• Are able to communicate effectively with and influence team members from other functions.
• Fully understand processes and are able to represent PMx on process initiatives.
• Beginning to establish own research areas within development sciences.

To be considered for this role you must have:
A PhD in Biology, Pharmacology, Engineering or a Pharmacy (Pharm.D.), Medicine (MD) degree and at least 3+ years of relevant Clinical Pharmacology experience.

Benefits
Regeneron provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves for eligible 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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.