Principal Quantitative Pharmacologist (Pharmacometrician)

Regeneron Pharmaceuticals • Warren, MI

23h • Onsite

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. A typical day might include prospectively designing and conducting quantitative or other PMx analyses of a sophisticated nature that is consistent with and encouraging of the program development strategy for one or more programs. The individual will keep PMx management advised of significant PMx results. As a PMx Program Representative on program teams, they will efficiently communicate sophisticated PMx results in colloquial terms that are understandable across the development teams. They will implement 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 IBs, 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. They will contribute accurate tables and figures for inclusion in slides for senior management presentations. The individual will be able to independently draft and review documentation for accuracy, clarity and messaging to ensure documents are appropriate for further PMx management review. They will perform additional analyses as required to support regulatory interactions. They will share scientific ideas and contribute to the mentoring of PMx staff. With some supervision, they will be able to competently represent PMx at pre-IND, Type C, pre-BLA, and other HA meetings.

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 4+ 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 is also advantageous.

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.

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Ph.D. or professional degree