Associate Director, Bioanalysis - PK & Biomarker (Remote)

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

Benefits offered by this job

Comprehensive benefits package

401(k) match

Paid time off

Job summary

Otsuka America Pharmaceutical Inc. is seeking a highly motivated Associate Director of Bioanalysis to lead outsourced bioanalytical activities supporting clinical programs, with a focus on PK and biomarker assays.

The role includes scientific leadership, vendor management, and collaboration with cross‑functional teams to ensure high-quality, regulatory submission‑ready data. The successful candidate will have a Ph.D.

Qualifications

• Ph.D. with a minimum of 5 years of relevant industry experience in regulated bioanalysis or MS/BS with at least 8 years in the field.
• Demonstrated expertise in regulated bioanalysis for PK and biomarker assays.
• Strong knowledge of global bioanalytical regulatory guidance and industry standards.
• Hands-on experience with LC‑MS/MS, ELISA, ECL, flow cytometry, and related platforms.
• Experience managing CROs and external partnerships, including timelines, budgets, quality, and compliance.

Responsibilities

• Provide strategic and scientific leadership for outsourced bioanalytical activities in clinical development.
• Oversee method development, qualification, validation, and data troubleshooting.
• Develop partnerships with bioanalytical CROs to ensure timely, audit-ready data.
• Monitor vendor performance against timelines, quality standards, and regulatory requirements.
• Ensure activities align with global regulatory guidance and best practices.
• Serve as SME on cross-functional teams, offering risk assessments and recommendations.
• Support regulatory submissions with submission-ready documents and responses to questions.
• Identify emerging technologies and biomarkers to enhance trial execution.

Skills

Leadership

Strategic thinking

Project management

Communication

Regulatory knowledge

Education

Ph.D. with 5+ years

MS/BS with 8+ years

Tools

LC‑MS/MS

ELISA

ECL

Flow cytometry

ADA/NAb assays

Job description

Otsuka America Pharmaceutical Inc. is seeking a highly motivated Associate Director of Bioanalysis to lead outsourced bioanalytical activities supporting clinical programs, with a focus on PK and biomarker assays.

The role includes scientific leadership, vendor management, and collaboration with cross‑functional teams to ensure high-quality, regulatory submission‑ready data. The successful candidate will have a Ph.D.