Senior Bioanalysis Strategy Lead (PK & Biomarkers)

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) match

Paid time off

Tuition reimbursement

Student loan assistance

Paid holidays

Job summary

Otsuka America Pharmaceutical Inc. seeks an Associate Director, Bioanalysis to provide strategic and scientific oversight of outsourced bioanalytical activities in clinical development, with a primary focus on PK and biomarkers, and expertise in LC-MS/MS, LBA, and cell-based assays.

You will lead interactions with CROs, ensure timely, audit-ready, and submission-ready data, and support regulatory submissions while evaluating emerging technologies and driving process improvements in a fast-paced

Qualifications

• Ph.D. with 5+ years in regulated bioanalysis or MS/BS with 8+ years in industry.
• Expertise in PK and biomarker assays for regulated clinical development.
• Strong knowledge of global bioanalytical regulatory guidance.

Responsibilities

• Provide strategic and scientific leadership for outsourced bioanalytical activities.
• Oversee method development, qualification, validation, and sample analysis.
• Lead CRO partnerships; manage deliverables, budgets, timelines, quality.
• Ensure study data is audit-ready and submission-ready.
• Evaluate emerging technologies and biomarker strategies.
• Support regulatory submissions and responses to agency questions.
• Drive continuous improvement and operational efficiencies in bioanalysis.

Skills

Bioanalytical leadership

CRO management

Mass spectrometry (LC-MS/MS)

Biomarker assays

Regulatory compliance

Cross-functional collaboration

Project management

Education

PhD (5+ yrs)

MS/BS (8+ yrs)

Tools

LC-MS/MS

ELISA

ECL

Flow cytometry

ADA/NAb assays

Job description

Otsuka America Pharmaceutical Inc. seeks an Associate Director, Bioanalysis to provide strategic and scientific oversight of outsourced bioanalytical activities in clinical development, with a primary focus on PK and biomarkers, and expertise in LC-MS/MS, LBA, and cell-based assays.

You will lead interactions with CROs, ensure timely, audit-ready, and submission-ready data, and support regulatory submissions while evaluating emerging technologies and driving process improvements in a fast-paced