Bioanalysis Strategy Lead — PK & Biomarkers (Remote)

Otsuka America Pharmaceutical Inc.; Des Moines (IA); Remote; USD 169,000 - 253,000; Full time

Benefits offered by this job

Comprehensive benefits package

401(k) with company match

Tuition reimbursement

Job summary

Otsuka America Pharmaceutical Inc. is seeking an Associate Director, Bioanalysis to lead outsourced bioanalytical activities for clinical development, with a focus on PK and biomarkers.

The role requires expertise in MS-based assays, LBA, and cell-based methodologies, plus strong CRO oversight and regulatory alignment. The candidate will drive assay strategy, collaborate with cross-functional teams, and evaluate emerging technologies to enhance data quality and trial execution in a fast-paced

Qualifications

• Ph.D. with at least 5 years of industry experience in regulated bioanalysis or MS-based assays.
• Experience in PK and biomarker assays.
• Knowledge of global bioanalytical regulatory guidance.
• Experience managing CROs and external partnerships.
• Strong communication and cross-functional collaboration.

Responsibilities

• Provide strategic and scientific leadership for outsourced bioanalytical activities.
• Oversee method development, qualification, validation, and sample analysis.
• Develop partnerships with CROs and external vendors.
• Monitor vendor performance and ensure timelines, quality, and regulatory compliance.
• Support regulatory submissions and inspection readiness.
• Identify and evaluate emerging technologies and biomarker strategies.
• Drive continuous improvement and adoption of digital solutions within bioanalysis.

Skills

Regulated bioanalysis

Pharmacokinetics (PK)

Biomarker assays

Mass spectrometry (LC-MS/MS)

Immunogenicity assays

CRO management

Cross-functional collaboration

Regulatory knowledge

Education

PhD in a related field

MS/BS with 8+ years of experience

Tools

LC-MS/MS

ELISA

ECL

Flow cytometry

Job description

Otsuka America Pharmaceutical Inc. is seeking an Associate Director, Bioanalysis to lead outsourced bioanalytical activities for clinical development, with a focus on PK and biomarkers.

The role requires expertise in MS-based assays, LBA, and cell-based methodologies, plus strong CRO oversight and regulatory alignment. The candidate will drive assay strategy, collaborate with cross-functional teams, and evaluate emerging technologies to enhance data quality and trial execution in a fast-paced