Bioanalysis Strategy Lead – PK & Biomarkers (Remote)

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

Benefits offered by this job

Comprehensive medical, dental, vision,

401(k) match

Flexible time off

Paid holidays & leave

Job summary

Otsuka America Pharmaceutical Inc. seeks an Associate Director, Bioanalysis to provide strategic and scientific oversight of outsourced bioanalytical activities for clinical development programs, focusing on PK and biomarker assays.

The role leads CRO interactions, ensures timely delivery of audit-ready data, and drives assay strategy, method development, validation, and troubleshooting while advancing bioanalytical capabilities across development portfolios.

Qualifications

• Ph.D. with a minimum of 5 years in regulated bioanalysis; or MS/BS with a minimum of 8 years in the field.
• Deep expertise in PK and biomarker assays and regulated bioanalysis.
• Strong knowledge of global regulatory bioanalytical guidance and standards.
• Hands-on experience with LC-MS/MS, ELISA, ECL, flow cytometry, and related platforms.

Responsibilities

• Provide strategic and scientific oversight for outsourced bioanalytical activities.
• Oversee method development, qualification, validation, and sample analysis with troubleshooting.
• Manage CRO partnerships, oversight of deliverables, budgets, and timelines.
• Ensure compliance with regulatory guidance and audit readiness for submissions.
• Lead evaluation of new analytical technologies and process improvements.

Skills

Mass spectrometry (LC-MS/MS)

Bioanalytical science

PK and biomarker assays

CRO management

Project management

Regulatory knowledge

Education

Ph.D.

M.S./B.S.

Tools

LIMS

ELISA/ECF platforms

Job description

Otsuka America Pharmaceutical Inc. seeks an Associate Director, Bioanalysis to provide strategic and scientific oversight of outsourced bioanalytical activities for clinical development programs, focusing on PK and biomarker assays.

The role leads CRO interactions, ensures timely delivery of audit-ready data, and drives assay strategy, method development, validation, and troubleshooting while advancing bioanalytical capabilities across development portfolios.