Remote Associate Director, Bioanalysis & PK Leadership

Otsuka America Pharmaceutical Inc.; Sacramento (CA); Remote; USD 169,000 - 253,000; Full time

Benefits offered by this job

Comprehensive medical coverage

Dental coverage

Vision coverage

Prescription drug coverage

Basic life insurance

AD&D insurance

Disability insurance

Tuition reimbursement

Student loan assistance

401(k) match

Flexible time off

Paid holidays

Paid leave programs

Job summary

Otsuka America Pharmaceutical Inc. is seeking an Associate Director, Bioanalysis to provide strategic and scientific oversight of outsourced bioanalytical activities for clinical development programs, focusing on pharmacokinetics and biomarkers.

You will lead interactions with CROs, ensure timely, audit-ready data, and guide assay strategy, development, validation, and troubleshooting. The ideal candidate will have deep expertise in mass spectrometry-based assays, LBA, cell-based methods, and a

Qualifications

• Ph.D. with 5+ years of regulated bioanalysis experience; or MS/BS with 8+ years in industry.
• Deep expertise in PK and biomarker assays for clinical development.
• Strong knowledge of global bioanalytical regulatory guidance and standards.
• Hands-on experience with LC-MS/MS, ELISA, ECL, and flow cytometry.

Responsibilities

• Provide strategic and scientific leadership for outsourced bioanalytical activities.
• Oversee method development, qualification, validation, and sample analysis with troubleshooting.
• Develop and maintain partnerships with bioanalytical CROs and external vendors.
• Monitor vendor performance to ensure timelines, quality, and compliance.
• Ensure activities align with global regulatory guidance and best practices.
• Act as bioanalytical SME on cross-functional teams and provide risk assessments.
• Support regulatory submissions with document review and inspection readiness.
• Evaluate emerging analytical technologies and biomarker strategies.
• Drive continuous improvement and adoption of new technologies.

Skills

Bioanalytical leadership

Pharmacokinetics expertise

Regulatory bioanalysis know-how

LC-MS/MS

Immunogenicity assays

CRO management

Project management

Science communication

Education

Ph.D. in a relevant field

MS/BS in a relevant field

Tools

LC-MS/MS

ELISA

ECL

Flow cytometry

Job description

Otsuka America Pharmaceutical Inc. is seeking an Associate Director, Bioanalysis to provide strategic and scientific oversight of outsourced bioanalytical activities for clinical development programs, focusing on pharmacokinetics and biomarkers.

You will lead interactions with CROs, ensure timely, audit-ready data, and guide assay strategy, development, validation, and troubleshooting. The ideal candidate will have deep expertise in mass spectrometry-based assays, LBA, cell-based methods, and a