Remote Associate Director, Bioanalysis & PK Strategy

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

Benefits offered by this job

Comprehensive benefits package

401(k) match

Paid holidays and leave

Job summary

Otsuka America Pharmaceutical Inc. is seeking a highly motivated senior science leader to oversee outsourced bioanalytical activities supporting clinical development, with a focus on PK and biomarker assays.

You will manage CRO partnerships, guide assay strategy, method development, validation, and data generation to ensure audit-ready and submission-ready analyses across programs. Strong collaboration with cross-functional teams is essential for success.

Qualifications

• Ph.D. with 5+ years in regulated bioanalysis; or MS/BS with 8+ years.
• Expertise in regulated bioanalysis supporting clinical development, including 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 with immunogenicity assays (ADA & NAb) is a plus; CRO management experience

Responsibilities

• Provide strategic and scientific leadership for outsourced bioanalytical activities supporting clinical development programs.
• Oversee bioanalytical method development, qualification, validation, and sample analysis with troubleshooting and optimization.
• Develop and maintain partnerships with bioanalytical CROs and external vendors to ensure successful execution.
• Monitor vendor performance and ensure adherence to study timelines, quality standards, and regulatory obligations.
• Ensure activities are conducted and documented per global regulatory guidance and best practices.
• Serve as SME on cross-functional teams, providing scientific recommendations and risk assessments.
• Support regulatory submissions by reviewing submission documents and agency responses.
• Identify and evaluate emerging analytical technologies and biomarker strategies.

Skills

Bioanalytical leadership

Regulatory bioanalysis

Pharmacokinetics

Cross-functional collaboration

Project management

Education

Ph.D. in a relevant field

MS/BS with 8+ years industry experience

Tools

LC-MS/MS

ELISA

ECL

Flow cytometry

ADA/NAb assays

Job description

Otsuka America Pharmaceutical Inc. is seeking a highly motivated senior science leader to oversee outsourced bioanalytical activities supporting clinical development, with a focus on PK and biomarker assays.

You will manage CRO partnerships, guide assay strategy, method development, validation, and data generation to ensure audit-ready and submission-ready analyses across programs. Strong collaboration with cross-functional teams is essential for success.