Bioanalysis Strategy Lead – PK & Biomarkers

Otsuka Pharmaceutical Co., Ltd; United States; A distancia; USD 169.000 - 253.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Comprehensive medical, dental, vision

401(k) with company match

Paid time off and holidays

Tuition reimbursement

Disability insurance

Life insurance

Descripción de la vacante

Otsuka Pharmaceutical Co., Ltd in United States seeks an Associate Director, Bioanalysis to provide strategic and scientific oversight of outsourced bioanalytical activities supporting clinical development programs, with a focus on PK and biomarkers.

The role leads CRO interactions, guides assay strategy, method development, validation, and data integrity, while evaluating new technologies to advance bioanalytical capabilities across the portfolio.

Formación

• Regulated bioanalysis experience in clinical development required.
• Strong PK and biomarker assay experience.
• Knowledge of global bioanalytical regulatory guidance.
• Experience managing CROs and external partnerships.

Responsabilidades

• Lead outsourced bioanalytical activities for clinical programs.
• Oversee method development, qualification, validation, and sample analysis.
• Maintain partnerships with CROs and external vendors.
• Ensure timelines, quality, and regulatory compliance.
• Support regulatory submissions and inspection readiness.
• Identify emerging technologies to enhance trial execution.

Conocimientos

Bioanalytical leadership

PK & Biomarker assays

Regulatory knowledge

CRO management

Project management

Communication skills

Cross-functional collaboration

Mass spectrometry-based assays

Educación

Ph.D. with 5+ years experience or MS/BS with 8+ years

Herramientas

LC-MS/MS

ELISA

ECL

Flow cytometry

ADA/NAb assays

Descripción del empleo

Otsuka Pharmaceutical Co., Ltd in United States seeks an Associate Director, Bioanalysis to provide strategic and scientific oversight of outsourced bioanalytical activities supporting clinical development programs, with a focus on PK and biomarkers.

The role leads CRO interactions, guides assay strategy, method development, validation, and data integrity, while evaluating new technologies to advance bioanalytical capabilities across the portfolio.