Principal Quantitative Pharmacologist; Pharmacometrician

Principal Quantitative Pharmacologist In Pharmacometrics (Pmx)

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 for you if you have :

• 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 Win Nonlin, NLME, Non Mem, STAN.

To be considered for this opportunity you will need:

• PhD with 4+ years or an MS degree with relevant industry experience. We expect this experience to include advanced pharmacokinetics, advanced pharmacological principles, non-compartmental analysis methods. 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 is also advantageous.