Remote Associate Director, Bioanalysis & PK Leadership

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

Benefits offered by this job

Comprehensive medical, dental, vision,

Prescription drug coverage

401(k) match

Job summary

Otsuka America Pharmaceutical Inc. seeks an Associate Director, Bioanalysis to provide strategic oversight of outsourced bioanalytical activities supporting clinical development.

The role focuses on PK and biomarkers, guiding assay strategy, method development, validation, and data integrity across global programs. The successful candidate will lead CRO collaborations, evaluate emerging technologies, and communicate complex scientific concepts to cross‑functional teams in a fast‑paced

Qualifications

• Ph.D. with 5+ years in regulated bioanalysis or MS/BS with 8+ years in regulated bioanalysis.
• Experience with pharmacokinetics (PK) and biomarker assays in clinical development.
• Deep knowledge of global bioanalytical regulatory guidance and industry standards.

Responsibilities

• Provide strategic and scientific leadership for outsourced bioanalytical activities.
• Oversee method development, qualification, validation, and sample analysis with troubleshooting.
• Develop and maintain partnerships with bioanalytical CROs and vendors.
• Monitor vendor performance against timelines, quality, and regulatory requirements.
• Ensure activities are conducted and documented per global regulatory guidance.

Skills

LC‑MS/MS

ELISA

ECL

Flow cytometry

Immunogenicity assays (ADA/NAb)

Education

Ph.D.

MS or BS with 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 oversight of outsourced bioanalytical activities supporting clinical development.

The role focuses on PK and biomarkers, guiding assay strategy, method development, validation, and data integrity across global programs. The successful candidate will lead CRO collaborations, evaluate emerging technologies, and communicate complex scientific concepts to cross‑functional teams in a fast‑paced