Associate Director, Bioanalysis & PK Strategy

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

Benefits offered by this job

Comprehensive medical, dental, vision

401(k) match

Paid holidays

Paid time off

Job summary

Otsuka America Pharmaceutical, Inc. seeks an Associate Director of Bioanalysis to provide strategic oversight of outsourced bioanalytical activities supporting clinical development, with focus on PK and biomarker assays.

You will lead interactions with CROs, ensure audit-ready data, and guide assay strategy, validation, and troubleshooting across global programs. The role requires deep expertise in LC-MS/MS, LBA, and cell-based technologies, with strong regulatory knowledge and collaboration

Qualifications

• Ph.D. with 5+ years of relevant industry experience in regulated bioanalysis; or MS/BS with 8+ years.
• 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 budgets and timelines.
• Excellent communication and cross-functional collaboration skills.
• Ability to lead assay strategy, method development, validation, and troubleshooting.

Responsibilities

• Provide strategic and scientific leadership for outsourced bioanalytical activities.
• Oversee method development, qualification, validation, and sample analysis with troubleshooting.
• Develop and maintain partnerships with CROs and external vendors to ensure successful execution.
• Monitor vendor performance and ensure timelines, quality, and regulatory compliance.
• Ensure activities align with global regulatory guidance and industry best practices.
• Serve as SME on cross-functional project teams and support decision making.
• Support regulatory submissions by contributing to submission documents and responses.
• Identify emerging technologies and biomarker strategies to enhance programs.
• Drive continuous improvement and adoption of new technologies and digital solutions.

Skills

Mass spectrometry

LBA assays

PK analysis

CRO management

Project management

Regulatory knowledge

Data interpretation

Communication skills

Education

Ph.D. in a relevant field

MS or BS with 8+ years in regulated bioanalysis

Tools

LC-MS/MS

ELISA

ECL

Flow cytometry

Job description

Otsuka America Pharmaceutical, Inc. seeks an Associate Director of Bioanalysis to provide strategic oversight of outsourced bioanalytical activities supporting clinical development, with focus on PK and biomarker assays.

You will lead interactions with CROs, ensure audit-ready data, and guide assay strategy, validation, and troubleshooting across global programs. The role requires deep expertise in LC-MS/MS, LBA, and cell-based technologies, with strong regulatory knowledge and collaboration