Principal Quantitative Pharmacologist

Regeneron Pharmaceuticals•Tarrytown, GA

3d•$150,500 - $245,500•Hybrid

About The Position

As a Principal Quantitative Pharmacologist in Pharmacometrics (PMx), this individual is encouraged to provide contributions to PMx results in support of programs. This role also prospectively provides PMx contributions in support of longer-term development strategies implemented over the course of multiple experiments, studies, and/or clinical trials. The individual will prospectively design and conduct 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 programs. They will keep PMx management advised of significant PMx results and act as a PMx Program Representative on program teams, efficiently communicating sophisticated PMx results in colloquial terms that are understandable across the development teams. This role 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, they will be responsible for authoring PMx contributions to regulatory documentation, such as IB’s, as well as briefing documents for pre-IND, EOP2, and other global Health Authority (HA) meetings. They will be responsible for the preparation and timely delivery of accurate and well-articulated study reports as well as regulatory submission documents as appropriate. This role also contributes accurate tables and figures for inclusion in slides for senior management presentations and is able to independently draft and review documentation for accuracy, clarity and messaging to ensure documents are appropriate for further PMx management review. Additional analyses will be performed as required to support regulatory interactions. The role involves sharing scientific ideas and contributing to the mentoring of PMx staff. With some supervision, the individual will competently represent PMx at pre-IND, Type C, pre-BLA, and other HA meetings.

Requirements

PhD with 5+ years or an MS degree with relevant industry experience.
Advanced pharmacokinetics
Advanced pharmacological principles
Non-compartmental analysis methods

Nice To Haves

Familiarity with other methodologies such as exposure-Response analysis methods
Translational modelling/pharmacology
Nonlinear Mixed Effects modeling
Logistic regression
Survival analysis
Bayesian approaches
Disease modelling/QSP

Responsibilities

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.