Remote Associate Director, Bioanalysis & PK Strategy

Otsuka America Pharmaceutical Inc.; Cheyenne (WY); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

401(k) match

Tuition reimbursement

Job summary

Otsuka America Pharmaceutical Inc. seeks an Associate Director, Bioanalysis to provide strategic and scientific oversight of outsourced bioanalytical activities for clinical programs, focusing on pharmacokinetics and biomarkers.

You will lead assay strategy, method development, validation, and data interpretation with CRO partners. In this role you will collaborate with cross-functional teams, drive process improvements, evaluate emerging technologies, and ensure audit-ready, submission-ready

Qualifications

• Ph.D. or MS/BS with extensive regulated bioanalysis experience.
• Experience supporting clinical development with PK/biomarker assays.
• Knowledge of global bioanalytical regulatory guidance and standards.

Responsibilities

• Provide strategic and scientific leadership for outsourced bioanalytical activities in clinical programs.
• Oversee method development, qualification, validation, and data troubleshooting.
• Manage CRO partnerships, vendor performance, budgets, and timelines.

Skills

Regulated bioanalysis

PK/biomarker assays

Mass spectrometry

CRO management

Regulatory knowledge

Education

Ph.D. in a relevant field

MS/BS with 8+ years experience

Tools

LC-MS/MS

ELISA/LBA

Flow cytometry

Job description

Otsuka America Pharmaceutical Inc. seeks an Associate Director, Bioanalysis to provide strategic and scientific oversight of outsourced bioanalytical activities for clinical programs, focusing on pharmacokinetics and biomarkers.

You will lead assay strategy, method development, validation, and data interpretation with CRO partners. In this role you will collaborate with cross-functional teams, drive process improvements, evaluate emerging technologies, and ensure audit-ready, submission-ready