Director, Pharmacokinetics & Bioanalysis

Remote • Posted 5 days ago • Updated 5 days ago
Contract W2
No Travel Required
Remote
$103 - $116/hr
Fitment

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Job Details

Skills

  • Assays
  • Collaboration
  • ELISA
  • GLP
  • Good Clinical Practice
  • Google Cloud Platform
  • Leadership
  • Lifecycle Management
  • Management
  • Mergers and Acquisitions
  • NDA
  • Pharmaceutics
  • Regulatory Compliance

Summary

Seeking an experienced Bioanalytical Development leader to oversee PK assay development and validation for oligonucleotide therapeutics. This role will support both clinical and nonclinical studies, drive assay lifecycle management, and collaborate cross-functionally with QCP, Clinical, and Translational teams.

Key Responsibilities:

  • Lead development and validation of PK and ligand-binding assays (LC-MS/MS, ELISA, qPCR)
  • Manage CROs and ensure high-quality, regulatory-compliant data
  • Support IND/NDA filings and ensure compliance with GLP/Google Cloud Platform and ICH guidelines
  • Analyze and interpret PK, ADME, and immunogenicity data

Key Requirements:

  • Ph.D. with 7+ years in bioanalytical development (biotech/pharma)
  • Strong expertise in oligonucleotide therapeutics (siRNA, ASOs)
  • Experience with complex biological matrices and assay validation
  • Proven leadership, CRO management, and cross-functional collaboration skills
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91099677
  • Position Id: 8956781
  • Posted 5 days ago
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