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Associate Director Preclinical & Translational PK/PD

$176.1k - $287.3k

Initial Therapeutics, Inc.

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, including working with the Research PK group to optimize mouse PK data for translation to nonhuman primate and human PK.
  • Effectively integrates and summarizes modeling and simulation analyses into usable 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, NONMEM, Monolix, ADAPT, MATLAB, SimBiology, etc.).
  • Strong theoretical and practical foundation in pharmacokinetics, including non-compartmental, compartmental, PK/PD and PBPK.
  • Effective 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.

Benefits
  • Health and wellness programs (medical, dental, vision, life, and disability insurance).
  • Fitness centers and wellness resources.
  • 401(k) company match and equity awards.
  • Annual bonuses and paid time off, including medical, parental, and military leave.
Salary Range (annually)

$176,100.00 - $287,300.00

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.

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Vacancy posted 3 days ago
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