Senior Bioanalysis Leader: PK & Biomarker Strategy (Remote)

Otsuka America Pharmaceutical Inc.; Dover (DE); A distancia; USD 169.000 - 253.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical insurance

Dental & Vision

401(k) match

Tuition reimbursement

Paid time off

Descripción de la vacante

Otsuka America Pharmaceutical, Inc. is seeking an Associate Director of Bioanalysis to provide strategic oversight of outsourced bioanalytical activities supporting clinical development, with a focus on PK and biomarker assays.

You will lead assay strategy, method development, validation, and troubleshooting, while ensuring audit-ready data. You will manage CRO partnerships, influence cross-functional teams, and explore new technologies to improve data quality and trial efficiency in a

Formación

• PhD with 5+ years in regulated bioanalysis or MS/BS with 8+ years of experience.
• Experience leading outsourced bioanalytical activities for clinical programs.
• Strong knowledge of global regulatory guidance and industry standards.

Responsabilidades

• Provide strategic and scientific leadership for outsourced bioanalytical activities.
• Oversee method development, qualification, validation, and sample analysis.
• Manage CRO relationships, budgets, timelines, and quality.
• Ensure regulatory readiness of data and submissions.
• Identify emerging technologies to enhance trial execution.
• Communicate complex science to diverse stakeholders.
• Support regulatory submissions and inspection readiness.
• Drive continuous improvement and digital solutions in bioanalysis.
• Collaborate with cross-functional teams to enable decisions.

Conocimientos

Bioanalysis expertise

PK analysis

LBA

Cell-based assays

CRO management

Regulatory knowledge

Project management

Scientific leadership

Communication

Educación

PhD or MS/BS with substantial experience

Herramientas

LC-MS/MS

ELISA

ECL

Flow cytometry

Descripción del empleo

Otsuka America Pharmaceutical, Inc. is seeking an Associate Director of Bioanalysis to provide strategic oversight of outsourced bioanalytical activities supporting clinical development, with a focus on PK and biomarker assays.

You will lead assay strategy, method development, validation, and troubleshooting, while ensuring audit-ready data. You will manage CRO partnerships, influence cross-functional teams, and explore new technologies to improve data quality and trial efficiency in a