Principal Quantitative Pharmacologist (Pharmacometrician)
Regeneron
13 hours ago
On-site
Tarrytown, NY
Clinical Research and Development
In this role, a typical day might include the following:
- Prospectively design and conduct quantitative or other PMx analyses of a sophisticated nature consistent with and supportive of the program development strategy.
- Advise PMx management of significant PMx results.
- Communicate sophisticated PMx results in colloquial terms understandable across development teams.
- Implement strategic or otherwise impactful changes to program strategy, direction, and/or regulatory interactions.
- Author PMx contributions to regulatory documentation (e.g., IBs) and prepare briefing documents for pre-IND, EOP2, and other global Health Authority meetings (with limited mentorship).
- Prepare and deliver accurate study reports and regulatory submission documents as appropriate.
- Contribute accurate tables and figures for senior management slide presentations.
- Independently draft and review documentation for accuracy, clarity, and messaging for PMx management review.
- Perform additional analyses as required to support regulatory interactions.
- Share scientific ideas and contribute to mentoring PMx staff.
- Represent PMx at pre-IND, Type C, pre-BLA, and other HA meetings (with some supervision).
This role may be for you if you have:
- PMx concepts/techniques including compartmental modeling, translational modeling/pharmacology, exposure-response, nonlinear mixed effects (population PK/PD), logistic regression, survival analysis, Bayesian approaches, and disease modeling/QSP.
- Advanced PMx methods for clinical trials including survival analysis, stratified/covariate analyses, and missing data strategies.
- Regulatory experience authoring briefing books/CTD summaries and contributing to HA meetings/negotiations through BLA approval.
- Proficient use of MS Excel, R, R-Studio, Phoenix WinNonlin, NLME, NonMem, STAN.
To be considered, you will need:
- PhD with 4+ years or MS with relevant industry experience, including advanced pharmacokinetics/pharmacology and non-compartmental analysis (exposure-response, translational modeling, nonlinear mixed effects, logistic regression, survival analysis, Bayesian approaches, disease modeling/QSP advantageous).
Apply now to take your first step towards living the Regeneron Way.
- Prospectively design and conduct quantitative or other PMx analyses of a sophisticated nature consistent with and supportive of the program development strategy.
- Advise PMx management of significant PMx results.
- Communicate sophisticated PMx results in colloquial terms understandable across development teams.
- Implement strategic or otherwise impactful changes to program strategy, direction, and/or regulatory interactions.
- Author PMx contributions to regulatory documentation (e.g., IBs) and prepare briefing documents for pre-IND, EOP2, and other global Health Authority meetings (with limited mentorship).
- Prepare and deliver accurate study reports and regulatory submission documents as appropriate.
- Contribute accurate tables and figures for senior management slide presentations.
- Independently draft and review documentation for accuracy, clarity, and messaging for PMx management review.
- Perform additional analyses as required to support regulatory interactions.
- Share scientific ideas and contribute to mentoring PMx staff.
- Represent PMx at pre-IND, Type C, pre-BLA, and other HA meetings (with some supervision).
This role may be for you if you have:
- PMx concepts/techniques including compartmental modeling, translational modeling/pharmacology, exposure-response, nonlinear mixed effects (population PK/PD), logistic regression, survival analysis, Bayesian approaches, and disease modeling/QSP.
- Advanced PMx methods for clinical trials including survival analysis, stratified/covariate analyses, and missing data strategies.
- Regulatory experience authoring briefing books/CTD summaries and contributing to HA meetings/negotiations through BLA approval.
- Proficient use of MS Excel, R, R-Studio, Phoenix WinNonlin, NLME, NonMem, STAN.
To be considered, you will need:
- PhD with 4+ years or MS with relevant industry experience, including advanced pharmacokinetics/pharmacology and non-compartmental analysis (exposure-response, translational modeling, nonlinear mixed effects, logistic regression, survival analysis, Bayesian approaches, disease modeling/QSP advantageous).
Apply now to take your first step towards living the Regeneron Way.