Director, Bioanalysis & PK Strategy

Otsuka Pharmaceutical Companies (U.S.); United States; On-site; USD 169,000 - 253,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Prescription drug coverage

Life insurance

AD&D

Disability insurance

Tuition reimbursement

Student loan assistance

401(k) match

Flexible time off

Paid holidays

Paid leave programs

Job summary

Otsuka Pharmaceutical Companies (U.S.) seeks an Associate Director, Bioanalysis to lead outsourced bioanalytical activities supporting clinical development, focusing on PK and biomarkers. You will oversee assay strategy, method development, and data integrity while collaborating with CROs and cross-functional teams to ensure high-quality submission-ready data.

The role requires a PhD with 5+ years or a MS/BS with 8+ years in regulated bioanalysis, with hands-on LC-MS/MS, ELISA/ECL, and flow

Qualifications

• Ph.D. with ≥5 years in regulated bioanalysis or MS/BS with ≥8 years in industry applicable to clinical development.
• Experience with PK and biomarker assays in regulated environments.
• Knowledge of global bioanalytical regulatory guidance and industry standards.

Responsibilities

• Provide strategic and scientific leadership for outsourced bioanalytical activities in clinical programs.
• Oversee method development, qualification, validation, and sample analysis with troubleshooting.
• Develop partnerships with CROs to ensure timely, audit-ready data delivery.
• Monitor vendor performance and ensure timelines, quality, and compliance.
• Ensure studies follow regulatory guidance and industry best practices.
• Act as SME on cross-functional project teams and support regulatory submissions.

Skills

PK Biomarker assays

LC-MS/MS

ELISA/ECL

Flow cytometry

Immunogenicity assays

CRO management

Regulatory knowledge

Project management

Strong communication

Education

PhD in Bioanalytical Science

MS/BS in a related field

Tools

Outsourced bioanalysis

Job description

Otsuka Pharmaceutical Companies (U.S.) seeks an Associate Director, Bioanalysis to lead outsourced bioanalytical activities supporting clinical development, focusing on PK and biomarkers. You will oversee assay strategy, method development, and data integrity while collaborating with CROs and cross-functional teams to ensure high-quality submission-ready data.

The role requires a PhD with 5+ years or a MS/BS with 8+ years in regulated bioanalysis, with hands-on LC-MS/MS, ELISA/ECL, and flow