Remote Associate Director Bioanalysis & PK Strategy

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision care

Prescription drug coverage

401(k) match

Paid holidays

Paid time off

Tuition reimbursement

Student loan assistance

Job summary

Otsuka America Pharmaceutical Inc. is seeking an Associate Director of Bioanalysis to provide strategic leadership for outsourced bioanalytical activities in clinical development, with a focus on PK and biomarkers.

The role leads external CRO collaborations, ensures timely delivery of audit-ready data, and guides assay strategy, method development, validation, and troubleshooting while driving adoption of new technologies and process improvements in a fast-paced environment.

Qualifications

• Ph.D. with at least 5 years in regulated bioanalysis or MS/PK focus.
• MD or MSc/BS with 8+ years relevant industry experience acceptable.
• Expertise in regulated bioanalysis for clinical development, PK and biomarkers.

Responsibilities

• Provide strategic leadership for outsourced bioanalytical activities in clinical development.
• Oversee method development, qualification, validation, and sample analysis with troubleshooting.
• Manage CRO partnerships, timelines, budgets, and regulatory compliance.
• Support regulatory submissions with scientific input and inspection readiness.

Skills

Regulated bioanalysis

Pharmacokinetics (PK)

Biomarker assays

Mass spectrometry

LBA and cell-based assays

Immunogenicity assays (ADA, NAb)

CRO/vendor management

Project management

Cross-functional communication

Education

Ph.D.

M.S.

B.S.

Tools

LC-MS/MS

ELISA

ECL

Flow cytometry

Job description

Otsuka America Pharmaceutical Inc. is seeking an Associate Director of Bioanalysis to provide strategic leadership for outsourced bioanalytical activities in clinical development, with a focus on PK and biomarkers.

The role leads external CRO collaborations, ensures timely delivery of audit-ready data, and guides assay strategy, method development, validation, and troubleshooting while driving adoption of new technologies and process improvements in a fast-paced environment.