Remote Bioanalysis: Associate Director for PK & Biomarkers

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

Benefits offered by this job

Medical, dental, vision benefits

401(k) match and retirement benefits

Paid time off and holidays

Job summary

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

You will lead assay strategy, method development, validation, and data integrity across CROs and internal teams. The role emphasizes expert knowledge in LC-MS/MS, ligand-binding, and cell-based assays, with strong regulatory awareness and collaboration across cross-functional stakeholders in a

Qualifications

• Ph.D. or higher with 5+ years in regulated bioanalysis.
• Experience with PK and biomarker assays using MS-based methods.
• Knowledge of global bioanalytical regulatory guidance.
• Experience managing CROs and external partnerships.
• Excellent written and oral communication; cross-functional collaboration.

Responsibilities

• Provide strategic and scientific leadership for outsourced bioanalytical activities.
• Oversee method development, qualification, validation, and sample analysis with troubleshooting.
• Develop partnerships with bioanalytical CROs and vendors for execution.
• Monitor vendor performance; ensure timelines, quality, and regulatory compliance.
• Ensure activities are conducted and documented per global guidance.
• Serve as bioanalytical SME on cross-functional teams; provide risk assessments.
• Support regulatory submissions with responses and inspection readiness.
• Evaluate emerging technologies and biomarker strategies for trials.
• Drive continuous improvement and adoption of new technologies and digital solutions.

Skills

Regulated bioanalysis expertise

Mass spectrometry assays

CRO management

Project management

Communication skills

Education

Ph.D. with 5+ years

M.S./B.S. with 8+ years

Tools

LC-MS/MS

ELISA

ECL

Flow cytometry

ADA/NAb assays (plus)

Job description

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

You will lead assay strategy, method development, validation, and data integrity across CROs and internal teams. The role emphasizes expert knowledge in LC-MS/MS, ligand-binding, and cell-based assays, with strong regulatory awareness and collaboration across cross-functional stakeholders in a