Associate Director Preclinical & Translational PK/PD

Regeneron Pharmaceuticals; Tarrytown (GA); Vor Ort; USD 176.000 - 287.000; Vollzeit

Zusammenfassung

Regeneron Pharmaceuticals seeks an Associate Director of Translational/Preclinical Modeling to develop quantitative and mechanistic PK/PD models that inform target biology, modality selection, and early clinical dose decisions. You will work to translate preclinical findings into human predictions, guiding dose selection and study design.

You will advance modeling science, present at meetings, and collaborate with Clinical Pharmacology and R&D teams to shape translational strategy. A Ph.D.

Qualifikationen

• Ph.D. or M.S. in pharmacokinetics, pharmaceutical sciences, engineering, applied mathematics or related disciplines.
• Greater than 6 years of pharmaceutical industry or related experience applying mechanism-based PK/PD modeling and simulation to guide R&D from discovery to IND-stage development.

Aufgaben

• Independently develops and implements quantitative and mechanistic PK/PD models informing preclinical-to-early clinical translation.
• Advances and guides the strategic direction of modeling and simulation sciences.
• Provides expert support to PK/PD projects to design, execute and interpret studies across species and translate to humans.
• Summarizes analyses into usable information for multidisciplinary teams.
• Collaborates with Clinical Pharmacology, Quantitative Pharmacology and R&D to advance modeling sciences.
• Presents work at scientific meetings and publishes in journals.

Kenntnisse

PK/PD modeling expertise

Cross-functional collaboration

Data interpretation

Scientific communication

Ausbildung

Ph.D. in pharmacokinetics or related

M.S. in related disciplines

Tools

Phoenix NLME

NONMEM

Monolix

ADAPT

MATLAB

SimBiology

Jobbeschreibung

The Associate Director of Translational/Preclinical Modeling develops and implements quantitative and mechanistic PK/PD models to aid in the understanding of target biology, therapeutic modality selection/optimization, and contributes to early clinical trial dose selection and/or design and advancement and strategic direction of modeling and simulation sciences.

A Typical Day May Include:

• Independently develops and implements quantitative and mechanistic mathematical PK/PD models that inform preclinical-to-early clinical translation, including human efficacious dose predictions and first-in-human dose selection.

• Actively contributes to the advancement and strategic direction of modeling and simulation sciences

• Provides expert support to pre-clinical PK/PD project representatives and R&D project teams to design, execute and interpret in vitro and in vivo quantitative pharmacology studies. This included working with the Research PK group to optimize use of mouse PK data to inform translation to nonhuman primate and human PK.

• Effectively integrates and summarizes modeling and simulation analyses into useable information for multidisciplinary project teams.

• Remains apprised of emerging science and literature, and effectively collaborates with subject matter experts in Clinical Pharmacology, Quantitative Pharmacology and R&D to advance modeling and simulation sciences.

• Presents work at internal/external scientific meetings and publishes work in scientific journals

This role might be for you if:

• Experience using one or more modeling and simulation platforms (e.g., Phoenix NLME, NONMEN, Monolix, ADAPT, MATLAB, SimBiology, etc.)

• Strong theoretical and practical foundation in pharmacokinetics, including non-compartmental, compartmental, PK/PD and PBPK.

• Effectively work in a fast-paced, highly-matrixed team-based environment and leverages scientific reasoning to influence key stakeholders.

• Ability to learn new areas of biological sciences to develop quantitative and mechanistic PK/PD models for emerging therapeutic modalities.

• Familiarity with biotherapeutic modalities, including monoclonal and bispecific antibodies, gene therapy, CAR-T, siRNAs and other targeting agents preferred

To be considered for this position, you must have:

Ph.D. or M.S. in pharmacokinetics, pharmaceutical sciences, engineering, applied mathematics or related disciplines with a track record of applying quantitative and mechanism-based PK/PD modeling and simulation approaches to advance the discovery and development of therapeutics. Greater than 6 years of pharmaceutical industry or related experience in developing and applying mechanism-based PK/PD models to guide R&D teams from early discovery to IND-stage clinical development.

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, 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.

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 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)

$176,100.00 - $287,300.00