Associate Director, Preclinical and Translational PK/PD
Core
Lead preclinical PK and PK/PD studies for early-stage drug discovery and IND projects, serving as a subject matter expert to guide study design and analyze data for regulatory submissions.
Role type
Senior IC Associate Director, Preclinical PK/PD
Builds
Preclinical PK/PD strategies, study designs, and regulatory data packages for therapeutic proteins and novel modalities.
Domain
Biopharma, Preclinical Pharmacology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
PK/PD study planning and coordination, nonclinical PK study management, PK/PD data analysis, regulatory summary writing, scientific report preparation, WinNonLin proficiency, therapeutic protein pharmacology expertise
Preferred skills
Experience with siRNA, CRISPR-based therapeutics, cell therapies, data visualization, AI software
Technologies
WinNonLin
Responsibilities
Provide input and oversight for preclinical in vivo studies, coordinate with scientific teams, analyze and present PK/PD data to project teams and senior management, prepare summary reports for regulatory submissions, collaborate with Toxicology, Pathology, and Clinical Pharmacology teams, maintain knowledge of scientific literature and regulatory guidance
Seniority
Senior, hands-on IC
