Associate Director, Bioanalysis — PK & Biomarkers (Remote)

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

Benefits offered by this job

Comprehensive medical, dental, vision,

Prescription drug coverage

Tuition reimbursement

Student loan assistance

401(k) match

Flexible time off

Paid holidays

Paid leave programs

Job summary

Otsuka America Pharmaceutical Inc. is seeking a scientifically driven Associate Director, Bioanalysis to oversee outsourced bioanalytical activities for clinical programs, with a focus on PK and biomarkers.

You will lead external CROs, shape assay strategy, and ensure audit‑ready data across development programs. Ideal candidates bring PhD with 5+ years or MS/BS with 8+ years of regulated bioanalysis experience, strong LC‑MS/MS/ELISA/ECL expertise, and robust cross‑functional collaboration and

Qualifications

• Ph.D. with a minimum of 5 years of relevant industry experience in regulated bioanalysis; or MS/BS with 8+ years.
• Experience in PK and biomarker assays and regulated bioanalysis for clinical development.
• Strong knowledge of global bioanalytical regulatory guidance and standards.
• Hands‑on experience with LC‑MS/MS, ELISA, ECL, flow cytometry and related platforms.
• Experience with ADA/NAb immunogenicity assays is a plus.
• Experience managing CROs and external partnerships with budgets and timelines.

Responsibilities

• Provide strategic and scientific leadership for outsourced bioanalytical activities.
• Oversee method development, qualification, validation, and sample analysis.
• Develop partnerships with bioanalytical CROs to ensure quality and timelines.
• Monitor vendor performance and regulatory compliance.
• Lead assay strategy, validation, troubleshooting, and data integrity.
• Evaluate emerging technologies to enhance clinical development.

Skills

Regulated bioanalysis

PK & biomarker assays

LC‑MS/MS

ELISA / ECL

CRO management

Project management

Cross‑functional collaboration

Scientific communication

Education

PhD with 5+ years

MS/BS with 8+ years

Job description

Otsuka America Pharmaceutical Inc. is seeking a scientifically driven Associate Director, Bioanalysis to oversee outsourced bioanalytical activities for clinical programs, with a focus on PK and biomarkers.

You will lead external CROs, shape assay strategy, and ensure audit‑ready data across development programs. Ideal candidates bring PhD with 5+ years or MS/BS with 8+ years of regulated bioanalysis experience, strong LC‑MS/MS/ELISA/ECL expertise, and robust cross‑functional collaboration and