Regeneron
Biotech
AssociateDirectorTranslationalPharmacokineticsandPharmacokinetic/Pharmacodynamic
“Associate Director Translational Pharmacokinetics and Pharmacokinetic/Pharmacodynamic at Regeneron. Skills: Translational Pharmacokinetics, PK/PD, Drug discovery. Provide input for preclinical in vivo studies. Oversee preclinical in vivo studies”
Industry & Context.
What They're Looking For.
Must Have
PhD in Pharmacology, Pharmacokinetics, Biology/Molecular Biology, or Biochemistry, 8-10 years of relevant experience in biotech or pharma, Deep theoretical and applied understanding of PK and PD, Proven ability to plan, coordinate, lead PK and/or PK/PD studies, Analyze related data, Familiarity with PK/PD (e.g., WinNonLin), Familiarity with data visualization software, Familiarity with AI software, Experience writing scientific reports, Experience writing regulatory summaries
Nice to Have
Experience with other modalities such as siRNA, Experience with CRISPR-based therapeutics, Experience with cell therapies
What You'll Do.
Provide input for preclinical in vivo studies
Oversee preclinical in vivo studies
Coordinate with scientific teams
Influence scientific teams
Manage nonclinical PK studies
Prepare summary reports for regulatory submissions
Serve as subject matter expert on Preclinical PK/PD
Guide design of preclinical PK/pharmacology studies
Collaborate with internal groups
Develop PK strategies for projects
Execute PK strategies for projects
Communicate project team queries to management
Communicate project expectations to management
Communicate project timelines to management
Conduct PK/PD analyses
Report PK/PD analyses
Work closely with Toxicology
Work closely with Pathology
Work closely with Clinical Pharmacology
Work closely with Quantitative Pharmacology
Deliver data for project progression
Deliver regulatory documents for project progression
Maintain current knowledge of scientific literature
Maintain current knowledge of regulatory guidance
Maintain current knowledge of best practices related to
How You'll Work.
Team & Collaboration
Discovery-stage project teams; Therapeutic Proteins; Therapeutic Function Areas; Assay Development; Precision Medicine; Preclinical Operations; PPK/PD management; Toxicology; Pathology; Clinical Pharmacology; Quantitative Pharmacology; Drug Safety and Pharmacometrics department
Communication Scope
Written communication; Verbal communication; Presentation skills; Influencing skills
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