Posted a month ago
DMPK and Bioanalytical Associate Director
VertexDMPK and Bioanalytical Associate Director
Requirements
DMPK and bioanalytical science expertise, Pharmacokinetics software knowledge, Bioanalytical assay development, CRO management, GLP/GxP knowledge, Regulatory data package preparation
Skills
DMPKBioanalysisPharmacokinetics
About the role
Responsibilities
- Act as the DMPK and Bioanalytical Lead on multidisciplinary project teams, communicating data, risk assessments, and recommendations to stakeholders
- Shape and deliver PK and bioanalytical strategies across a portfolio of biotherapeutic programs to inform development and regulatory decision-making
- Contribute scientific input to the design, execution, and interpretation of in vivo PK and PK/PD studies
- Plan and manage bioanalytical testing activities, including method development and phase-appropriate qualification and validation of assays
- Oversee CRO management, including evaluation, selection, vendor audits, and troubleshooting assay performance
- Prepare regulatory data packages, dossiers, and responses for health authority interactions, audits, and inspections
Requirements
- Deep expertise in DMPK and bioanalytical science, with the ability to integrate in vitro and in vivo data
- Experience with pharmacokinetics software (e.g., Phoenix WinNonlin)
- Specialized knowledge in bioanalytical assay development for large-molecule therapeutics (ligand binding, cell-based PK, immunogenicity, and biomarker assays)
- Strong experience managing CROs in regulated environments with oversight of GLP/GxP compliance
- Advanced degree (PhD, Master's, or Bachelor's) with relevant industry experience:
- PhD with 6-8+ years of post-doctoral experience
- Master's with 9+ years of experience
- Bachelor's with 11+ years of experience
Preferred Qualifications
- Prior participation in regulatory inspections, audits, or health authority interactions
- Ability to mentor and advise others on complex bioanalytical strategies
About the Company
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company is recognized for its work in treating the underlying causes of multiple chronic, life-shortening genetic diseases and continues to advance a robust clinical pipeline across various modalities.
ScoutJobs Agent
Get matches like this delivered daily
Sign up free — we'll pull jobs that fit your CV from across the web and rank them for you.
Get started — it's freeDMPK and Bioanalytical Associate Director
Vertex · Seattle
