Principal Quantitative Pharmacologist – Pharmacometrician
| Company | Regeneron Pharmaceuticals |
|---|---|
| Location | Cambridge, MA, USA, Berkeley Heights, NJ, USA, Tarrytown, NY, USA |
| Salary | $148300 – $241900 |
| Type | Full-Time |
| Degrees | Master’s, PhD |
| Experience Level | Senior, Expert or higher |
Requirements
- Understanding of PMx concepts and techniques, compartmental modeling, translational modelling/pharmacology, Exposure-Responses analysis methods, Nonlinear Mixed Effects modeling (population PK/PD), logistic regression, survival analysis, Bayesian approaches, disease modelling/QSP.
- Knowledge of advanced PMx methodologies applicable to clinical trials, such as survival analysis, stratified or covariate analyses, and strategies for handling missing data.
- Has regulatory experience through authoring of regulatory briefing books, CTD summaries, contribution at HA meetings, HA negotiations through regulatory review and approval of BLA or equivalent.
- Proficient in use of analysis tools such as: MS-Excel, R, R-Studio, Phoenix WinNonlin, NLME, NonMem, STAN.
- PhD with 3+ years or an MS degree with relevant industry experience. We expect this experience to include advanced pharmacokinetics, advanced pharmacological principles, non-compartmental analysis methods.
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.
Preferred Qualifications
- 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.