Full Job Description
Senior Director, Preclinical & Translational PK/PD
Location: Tarrytown, NY
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
This role requires:
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
Salary Range (annually)
$242,000.00 - $403,300.00
