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 WinNonlin, NLME, NonMem, STAN.
To be considered for this opportunity you will need:
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. 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.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
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