Associate Director, Bioanalysis: PK & Biomarker Outsourcing

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

Benefits offered by this job

Comprehensive benefits

401(k) match

Flexible time off

Job summary

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

You will lead interactions with external CROs and cross-functional teams to deliver audit-ready data and support regulatory submissions. The role requires deep expertise in MS-based assays (LC-MS/MS, LBA, cell-based methods), strong knowledge of global regulatory requirements, and the ability to

Qualifications

• Ph.D. with at least 5 years in regulated bioanalysis
• Experience with PK and biomarker assays
• Knowledge of global bioanalytical regulatory guidance
• Hands-on experience with LC-MS/MS, ELISA, ECL, flow cytometry
• Experience managing CROs and external partnerships
• Strong project management and communication skills

Responsibilities

• Provide strategic and scientific leadership for outsourced bioanalytical activities supporting clinical development programs.
• Oversee bioanalytical method development, qualification, validation, and sample analysis activities.
• Develop and maintain strong partnerships with bioanalytical CROs and other external vendors.
• Monitor vendor performance and ensure adherence to study timelines, quality standards, and regulatory requirements.
• Ensure bioanalytical activities are conducted and documented per global regulatory guidance.
• Serve as SME on cross-functional project teams providing scientific recommendations.
• Support regulatory submissions with submission-related documents and responses.
• Identify and evaluate emerging analytical technologies and biomarker strategies.
• Drive continuous improvement and champion new technologies within bioanalysis.

Skills

Regulated bioanalysis

PK & biomarkers

Mass spectrometry

LBA assays

CRO management

Project management

Scientific communication

Cross-functional collaboration

Education

Ph.D. in related field

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

Tools

LC-MS/MS

ELISA

ECL

Flow cytometry

Job description

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

You will lead interactions with external CROs and cross-functional teams to deliver audit-ready data and support regulatory submissions. The role requires deep expertise in MS-based assays (LC-MS/MS, LBA, cell-based methods), strong knowledge of global regulatory requirements, and the ability to