Remote Associate Director, Bioanalysis & PK Strategy

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

Job summary

Otsuka America Pharmaceutical, Inc. is seeking a highly capable Associate Director, Bioanalysis to provide strategic oversight of outsourced bioanalytical activities supporting clinical programs, with a focus on PK and biomarkers.

The role involves leading external CRO interactions, assay strategy, method development, validation, and data integrity across global regulatory standards. The successful candidate will guide scientists in MS-based assays, ligand-binding methods, and cell-based

Qualifications

• Regulated bioanalysis experience for clinical development.
• Experience with PK and biomarker assays in regulated environments.

Responsibilities

• Provide strategic and scientific leadership for outsourced bioanalytical activities.
• Oversee method development, qualification, validation, and sample analysis.
• Develop and maintain partnerships with bioanalytical CROs and vendors.
• Monitor vendor performance for timelines, quality and regulatory compliance.
• Ensure activities meet global regulatory guidance and industry best practices.
• Serve as SME on cross-functional project teams and provide risk assessments.
• Support regulatory submissions with submission-related documents and agency responses.
• Identify emerging analytical technologies and biomarker strategies.
• Drive continuous improvement and adoption of new technologies across bioanalysis.

Skills

Regulated bioanalysis

Pharmacokinetics

Biomarker assays

CRO management

Project management

Mass spectrometry

Cell-based assays

Elisa/ECL

Communication

Education

Ph.D. with 5+ years

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

Tools

LC-MS/MS

ELISA

ECL

Flow cytometry

Job description

Otsuka America Pharmaceutical, Inc. is seeking a highly capable Associate Director, Bioanalysis to provide strategic oversight of outsourced bioanalytical activities supporting clinical programs, with a focus on PK and biomarkers.

The role involves leading external CRO interactions, assay strategy, method development, validation, and data integrity across global regulatory standards. The successful candidate will guide scientists in MS-based assays, ligand-binding methods, and cell-based