Senior Bioanalysis Lead: PK & Biomarkers | Remote

Otsuka America Pharmaceutical Inc.; Harrisburg (Dauphin County); Remote; USD 169,000 - 253,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401(k) match

Paid holidays

Paid leave

Job summary

Otsuka America Pharmaceutical Inc. is seeking an Associate Director of Bioanalysis to provide strategic oversight of outsourced bioanalytical work supporting clinical programs. The role emphasizes PK and biomarker assays, with leadership across CROs and cross-functional teams.

The ideal candidate will drive method development, validation, troubleshooting, and data readiness for submissions, while exploring new technologies to enhance clinical trial quality and efficiency.

Qualifications

• Ph.D. or equivalent with 5+ years in regulated bioanalysis.
• MS/BS with 8+ years in regulated bioanalysis.
• Experience with PK/biomarker assays and regulatory guidance.

Responsibilities

• Provide strategic and scientific leadership for outsourced bioanalytical activities.
• Oversee method development, qualification, validation, and sample analysis.
• Develop and maintain CRO partnerships for successful execution.
• Monitor vendor performance to meet timelines and quality standards.
• Ensure activities comply with global regulatory guidance and best practices.
• Serve as SB/SME on cross-functional teams for decision making.
• Support regulatory submissions with review of related documents.
• Identify and evaluate emerging analytical technologies for trials.
• Drive continuous improvement and adoption of new technologies.

Skills

CRO management

Project management

Cross-functional leadership

Scientific communication

Education

Ph.D. with 5+ years regulated bioanalysis

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

Tools

LC‑MS/MS

ELISA

ECL

Flow cytometry

Job description

Otsuka America Pharmaceutical Inc. is seeking an Associate Director of Bioanalysis to provide strategic oversight of outsourced bioanalytical work supporting clinical programs. The role emphasizes PK and biomarker assays, with leadership across CROs and cross-functional teams.

The ideal candidate will drive method development, validation, troubleshooting, and data readiness for submissions, while exploring new technologies to enhance clinical trial quality and efficiency.