Sr Dir Preclinical & Translational PK/PD

Regeneron Pharmaceuticals•Tarrytown, GA

6d•$242,000 - $403,300•Onsite

About The Position

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Director to support PK and PK/PD requirements for early-stage drug discovery through IND/CTA projects. You'll utilize a mastery level of PK/PD knowledge and strategic leadership skills to effectively develop and implement strategic analyses supporting research and development projects. You'll exert influence across the organization at multiple levels, including individual contributors (in and out of the function), development program teams, and other functional managers, and will be accountable for the PK/PD evaluation of a portfolio of projects and/or highly complex programs/platforms that can be wide in scope. This role is suited for individuals who thrive in a fast-paced, collaborative environment, are passionate about science and motivated to contribute to bringing new drugs to patients, and desire exposure to multiple therapeutic areas and emerging modalities. We're looking for seasoned and tenured scientists with a demonstrated ability to provide significant impact on the organization and external groups, readily able to influence and effect change. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Requirements

A PhD in Pharmacology, Pharmacokinetics, Biology/Molecular Biology, or Biochemistry, with more than 12–14 years of relevant experience in biotech or pharma
Deep theoretical and applied understanding of PK and PD to interpret the pharmacology and biology of therapeutic proteins; experience with other modalities such as siRNA, peptide-conjugates, CRISPR-based therapeutics, and cell therapies is highly beneficial
Proven ability to plan, coordinate, and lead PK and/or PK/PD studies, and analyze related data
Excellent written and verbal communication, presentation, influencing, and leadership skills
Familiarity with PK/PD software (e.g., WinNonLin), data visualization and AI software, and extensive experience writing scientific reports and regulatory summaries

Nice To Haves

experience with other modalities such as siRNA, peptide-conjugates, CRISPR-based therapeutics, and cell therapies is highly beneficial

Responsibilities

Serves as a subject matter expert regarding Preclinical and Translational PK/PD on Discovery-stage project teams, guiding the design of preclinical pharmacology, PK, and PK/PD studies
Collaborates with various internal groups such as Therapeutic Proteins, Therapeutic Function Areas, Assay Development, Precision Medicine, Preclinical Operations, and TPK/PD management to develop and execute PK/PD strategies for projects
Provides input and oversight for preclinical in vivo studies, coordinating with scientific teams conducting these studies
Manages nonclinical PK and PK/PD studies, and conducts and reports PK/PD analyses based on data from preclinical studies
Analyzes and presents PK and PK/PD data to project teams, TPK/PD, and senior management
Derives first in human (FIH) dose predictions in collaboration with Clinical Pharmacology
Works closely with Toxicology, Pathology, Clinical Pharmacology, and Quantitative Pharmacology teams within the Drug Safety and Pharmacometrics department to deliver data and regulatory documents supporting project progression
Prepares summary reports for regulatory submissions
Effectively communicates project team queries, expectations, and timelines to management
Maintains current knowledge of scientific literature, regulatory guidance, and best practices related to PK/PD of protein therapeutics, siRNA, CAR-T, and gene therapy modalities