Principal Quantitative Pharmacologist

Regeneron Pharmaceuticals, Inc.; United States; On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Bonuses

Equity awards

Pension / retirement benefits

401(k) company match

Health & wellness programs

Fitness centers

Insurance benefits (medical, dental, v

Life and disability

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Principal Quantitative Pharmacologist in Pharmacometrics (PMx) to lead advanced PMx analyses supporting development programs.

This on-site role is based in Tarrytown, NY, and collaborates with cross-functional teams to influence program strategy and regulatory interactions. You will author PMx contributions to regulatory documentation and briefing packs, deliver timely study reports, and mentor PMx staff.

Qualifications

• PhD with 5+ years in PMx or related field; core pharmacometrics knowledge.
• Experience designing and communicating PMx analyses for development programs.
• Familiarity with regulatory interactions and regulatory documentation.

Responsibilities

• Design and conduct quantitative PMx analyses aligned with program strategy.
• Communicate PMx results clearly to cross-functional teams.
• Draft PMx contributions to regulatory documents (IBs) and briefing packs.
• Prepare accurate study reports and regulatory submission documents.
• Contribute to mentoring PMx staff and represent PMx at HA meetings.

Skills

PMx analyses

Pharmacokinetics

Non-compartmental analysis

Exposure-Response

Translational modelling

Nonlinear mixed effects modelling

Logistic regression

Survival analysis

Bayesian approaches

Disease modelling/QSP

Education

PhD with 5+ years

MS degree with relevant industry experience

Tools

NONMEM

R

Python

SAS

Job description

Build Our Future Together

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.

When & where:

Work Location: Tarrytown, NY

Work model/flexibility: 4 days per week onsite

Discover your role

• 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.
• Implies 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 requires:

• PhD with 5+ 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? We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

• annual bonuses or other incentive plans
• equity awards
• pension or retirement benefits
• 401(k) company match
• health and wellness programs
• fitness centers
• insurance benefits (e.g. medical, dental, vision, life and disability)
• paid time off
• family support benefits

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such check