Remote Associate Director, Bioanalysis & PK Strategy

Otsuka America Pharmaceutical Inc.; Salt Lake City (UT); Remote; USD 169,000 - 253,000; Full time

Benefits offered by this job

Comprehensive medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

Tuition reimbursement

Student loan assistance

401(k) match

Flexible time off

Paid holidays

Paid leave

Job summary

Otsuka America Pharmaceutical Inc. seeks a scientifically driven Associate Director, Bioanalysis to oversee outsourced bioanalytical activities for clinical development, with a focus on PK and biomarkers.

You will lead method development, validation, and data delivery from CROs, ensuring audit-ready and submission-ready results. You will manage external partnerships, monitor performance, and drive adoption of innovative technologies while ensuring global regulatory alignment across programs in a

Qualifications

• Ph.D. with a minimum of 5 years of relevant industry experience in regulated bioanalysis or MS/BS with 8+ years experience.
• Demonstrated 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 other platforms.
• Experience with immunogenicity assays (ADA, NAb) is a plus.
• Experience managing CROs and external partnerships, including oversight of deliverables, budgets, timelines, quality, and compliance.

Responsibilities

• Provide strategic and scientific leadership for outsourced bioanalytical activities supporting clinical development programs.
• Oversee bioanalytical method development, qualification, validation, and sample analysis activities, including troubleshooting and optimization.
• Develop and maintain partnerships with bioanalytical CROs and external vendors to ensure successful execution of strategies.
• Monitor vendor performance and ensure adherence to study timelines, quality standards, contractual obligations, and regulatory requirements.
• Ensure activities are conducted in accordance with global regulatory guidance and industry best practices.
• Serve as bioanalytical SME on cross-functional teams, providing recommendations and risk assessments.
• Support regulatory submissions by contributing to and reviewing submission-related documents and agency responses.
• Identify and evaluate emerging technologies and biomarker strategies to enhance development programs.
• Drive continuous improvement and champion new technologies and operational efficiencies.

Skills

Regulated bioanalysis

Pharmacokinetics (PK)

Biomarkers

CRO management

Project management

Excellent communication

Education

PhD in a relevant field

MS or BS in a relevant field

Tools

LC-MS/MS

ELISA

ECL

Flow cytometry

Job description

Otsuka America Pharmaceutical Inc. seeks a scientifically driven Associate Director, Bioanalysis to oversee outsourced bioanalytical activities for clinical development, with a focus on PK and biomarkers.

You will lead method development, validation, and data delivery from CROs, ensuring audit-ready and submission-ready results. You will manage external partnerships, monitor performance, and drive adoption of innovative technologies while ensuring global regulatory alignment across programs in a