Remote Associate Director, Bioanalysis & PK Leadership

Otsuka America Pharmaceutical Inc.; San Juan (PR); Remote; USD 169,000 - 253,000; Full time

Benefits offered by this job

Comprehensive medical benefits

401(k) match

Job summary

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

The role leads interactions with CROs, guiding assay strategy, method development, validation, troubleshooting, and ensuring audit- and submission-ready data while collaborating with cross-functional stakeholders.

Qualifications

• Ph.D. or equivalent with senior industry experience in regulated bioanalysis for clinical development.
• Deep expertise in PK and biomarker assays and knowledge of global bioanalytical regulatory guidance.

Responsibilities

• Provide strategic and scientific leadership for outsourced bioanalytical activities in clinical development.
• Oversee method development, qualification, validation, and sample analysis with troubleshooting and optimization.

Skills

bioanalytical leadership

project management

effective communication

cross-functional collaboration

Education

Ph.D. with 5+ years in regulated bioanalysis

M.S./B.S. with 8+ years in regulated bioanalysis

Tools

LC-MS/MS

ELISA

ECL

Flow cytometry

Job description

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

The role leads interactions with CROs, guiding assay strategy, method development, validation, troubleshooting, and ensuring audit- and submission-ready data while collaborating with cross-functional stakeholders.