Principal Quantitative Pharmacologist

BioSpace; New Jersey; On-site; USD 151,000 - 246,000; Full time

Job summary

Regeneron is seeking a Principal Quantitative Pharmacologist in Pharmacometrics (PMx) to design and conduct sophisticated PMx analyses, supporting program development strategies across multiple experiments and clinical trials. The role communicates PMx results to development teams and helps shape regulatory interactions with informed, data-driven insights.

The candidate will contribute to PMx documentation for regulatory submissions, mentor staff, and represent PMx at pre-IND and HA meetings

Qualifications

• PhD with 5+ years or an MS with relevant industry experience.
• Familiarity with exposure-response analysis, translational modelling/pharmacology, NLME, logistic regression, survival analysis, Bayesian approaches, disease modelling/QSP advantageous.

Responsibilities

• Designs and conducts quantitative PMx analyses to support program development strategies.
• Keeps PMx management informed of significant results.
• Communicates robust PMx results to cross-functional teams in accessible language.
• Implements PMx changes to program strategy and regulatory interactions.
• Authors PMx contributions to regulatory documents (IBs) and briefing documents for pre-IND, EOP2, and HA meetings.
• Prepares and delivers study reports and regulatory submission documents.
• Contributes tables and figures for senior management presentations.
• Drafts and reviews PMx documentation for clarity and accuracy.
• Performs additional analyses to support regulatory interactions.
• Mentors PMx staff and represents PMx at meetings with some supervision.

Skills

Pharmacokinetics

Pharmacology

Non-compartmental analysis

Bayesian methods

Survival analysis

Exposure-Response

Education

PhD with 5+ yrs

MS with industry experience

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.


• 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 IBs, 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.

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, and 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.

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 checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$150,500.00 - $245,500.00