Bioanalytical Sciences Director — PK & Immunogenicity Lead

Real; United States; Sur place; USD 180 000 - 240 000; Plein temps

Résumé du poste

Mentari Therapeutics seeks an Associate Director/Director of Bioanalytical Sciences to design and oversee bioanalytical strategies for development programs. You will lead outsourced activities, ensuring PK, ADA/nAb, and biomarker data meet regulatory expectations across GLP/GCLP environments.

The role requires extensive hands‑on expertise, strong CRO oversight, and cross‑functional collaboration with nonclinical development, clinical pharmacology, and translational medicine to deliver

Qualifications

• Advanced degree and 5+ years of industry or CRO experience in bioanalytical sciences.
• Deep expertise in regulated bioanalysis for biologics development.
• Hands-on bioanalytical work in PK/TK, ADA, nAb, and biomarker assays.

Responsabilités

• Lead biosanalytical strategy for clinical and nonclinical studies.
• Manage CROs, timelines, budgets, and regulatory compliance.
• Oversee development, validation, and sample analysis for PK/TK, ADA, nAb, and biomarkers.
• Review data and ensure rigor, data integrity, and regulatory readiness.
• Collaborate across functions to support study design and sample strategy.

Connaissances

Bioanalytical science

CRO management

Project management

Communication

Formation

PhD/MS/BS in a relevant field

Outils

ELISA

MSD/ECL

LC-MS/MS

Description du poste

Mentari Therapeutics seeks an Associate Director/Director of Bioanalytical Sciences to design and oversee bioanalytical strategies for development programs. You will lead outsourced activities, ensuring PK, ADA/nAb, and biomarker data meet regulatory expectations across GLP/GCLP environments.

The role requires extensive hands‑on expertise, strong CRO oversight, and cross‑functional collaboration with nonclinical development, clinical pharmacology, and translational medicine to deliver