Strategic Leader, Bioanalysis & CRO Partnerships

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

Benefits offered by this job

Comprehensive medical, dental, vision,

401(k) match

Tuition reimbursement

Job summary

Otsuka America Pharmaceutical Inc. is seeking an Associate Director, Bioanalysis to provide strategic and scientific oversight of outsourced bioanalytical activities across clinical development, with a focus on pharmacokinetics (PK) and biomarkers.

You will lead assay strategy, method development, validation, troubleshooting, and collaborate with cross-functional teams to ensure data integrity and regulatory readiness.

Qualifications

• Ph.D. with at least 5 years in regulated bioanalysis
• MS/BS with at least 8 years in regulated bioanalysis
• Experience with PK and biomarker assays and global regulatory guidance

Responsibilities

• Provide strategic and scientific leadership for outsourced bioanalytical activities.
• Oversee method development, qualification, validation, and sample analysis with troubleshooting.
• Develop partnerships with bioanalytical CROs and external vendors.
• Monitor vendor performance, timelines, quality, and regulatory compliance.
• Ensure activities follow global regulatory guidance and SOPs.
• Serve as SMEs on cross-functional teams, advising risk assessments and decisions.
• Support regulatory submissions with documentation and responses.

Skills

Bioanalytical leadership

LC-MS/MS expertise

ELISA / ECL

Flow cytometry

ADA / NAb assays

CRO management

Project management

Regulatory awareness

Scientific communication

Education

PhD with 5+ years

MS/BS with 8+ years

Tools

LC-MS/MS

ELISA

ECL

Flow cytometry

Job description

Otsuka America Pharmaceutical Inc. is seeking an Associate Director, Bioanalysis to provide strategic and scientific oversight of outsourced bioanalytical activities across clinical development, with a focus on pharmacokinetics (PK) and biomarkers.

You will lead assay strategy, method development, validation, troubleshooting, and collaborate with cross-functional teams to ensure data integrity and regulatory readiness.