Regeneron
Healthcare
PrincipalQuantitativePharmacologist(Pharmacometrician)
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“Principal Quantitative Pharmacologist (Pharmacometrician) at Regeneron. Skills: Pharmacometrics, Quantitative pharmacology, Regulatory interactions. Design quantitative PMx analyses. Conduct quantitative PMx analyses”
Industry & Context.
Quantitative analysis
What They're Looking For.
Must Have
PhD with 4+ years experience, MS degree with relevant industry experience, Advanced pharmacokinetics experience, Advanced pharmacological principles experience, Non-compartmental analysis methods experience
Nice to Have
Exposure-Response analysis methods familiarity, Translational modelling/pharmacology familiarity, Nonlinear Mixed Effects modeling familiarity, Logistic regression familiarity, Survival analysis familiarity, Bayesian approaches familiarity, Disease modelling/QSP familiarity
What You'll Do.
Design quantitative PMx analyses
Conduct quantitative PMx analyses
Keep PMx management advised
Communicate PMx results
Implement PMx strategic changes
Author PMx contributions
Prepare study reports
Deliver study reports
Prepare regulatory documents
Deliver regulatory documents
Contribute tables for presentations
Contribute figures for presentations
Perform additional analyses
Share scientific ideas
Represent PMx at meetings
How You'll Work.
Team & Collaboration
Program teams; Development teams; Health Authority meetings
Communication Scope
Communicate results; Author documentation
Full Job Description
As a Principal Quantitative Pharmacologist in Pharmacometrics (PMx), this individual is encouraged to provide contributions to PMx results in support of programs. Is further able to prospectively provide PMx contributions in support of longer-term development strategies implemented over the course of multiple experiments, studies, and/or clinical trials. **In this role, a typical day might include the following:** * Prospectively designs and conducts quantitative or other PMx analyses of a sophisticated nature or otherwise appropriate that is consistent with and encouraging of the program development strategy for one or more program. * Keeps PMx management advised of significant PMx results. * As a PMx Program Representative on program teams, efficiently communicate sophisticated PMx results in colloquial terms that are understandable across the development teams. * Implements PMx management strategic or otherwise impactful changes to the program strategy, direction, and/or regulatory interactions. * As a PMx Program Representative, with limited mentorship from PMx management is responsible for, authoring PMx contributions to regulatory documentation, such as IB’s, as well as briefing document for; pre-IND, EOP2, and other global Health Authority (HA) meetings. * Is responsible for the preparation and timely delivery of accurate and well-articulated study reports was well as regulatory submission documents as appropriate. * Contributes accurate tables and figures for inclusion in slides for senior management presentations. * Is able to independently draft and review documentation for accuracy, clarity and messaging to ensure documents are appropriate for further PMx management review. * Performs additional analyses as required to support regulatory interactions. * Share scientific ideas and contribute to the mentoring of PMx staff. * With some supervision is able to competently represents PMx at pre-IND, Type C, pre- BLA, and other HA meetings. **This role may be fo
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