Bioanalysis Strategy Director (Remote)

Otsuka America Pharmaceutical Inc.

Charleston (WV)

Remote

USD 169,000 - 253,000

Full time

14 days+

Application generator

Turn this role into an interview — a resume and cover letter built around what this employer wants.

Get past ATS filters

Benefits offered by this job

Comprehensive medical coverage

Dental coverage

Vision coverage

Life insurance

Disability insurance

Tuition reimbursement

401(k) match

Flexible time off

Paid holidays

Paid leave

Job summary

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

The role leads interactions with CROs, guiding assay strategy, method development, validation, and data submission readiness while driving adoption of emerging technologies to enhance data quality and trial efficiency.

Qualifications

Ph.D. with a minimum of 5 years of relevant industry experience in regulated bioanalysis; or MS/B.S. with a minimum of 8 years of relevant industry experience.
Demonstrated expertise in regulated bioanalysis supporting clinical development, including pharmacokinetic 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 with immunogenicity assays (ADA, NAb) is a plus
Experience managing CROs and external partnerships with oversight of deliverables, budgets, timelines, quality

Responsibilities

Provide strategic and scientific leadership for outsourced bioanalytical activities in clinical development.
Oversee method development, qualification, validation, and sample analysis with troubleshooting.
Develop and maintain partnerships with bioanalytical CROs and vendors for successful execution.
Monitor vendor performance, timelines, quality, and regulatory obligations.
Ensure bioanalytical activities comply with global regulatory guidance and best practices.
Serve as SME on cross-functional teams, offering scientific recommendations and risk assessments.
Support regulatory submissions with documentation, agency responses, and inspection readiness.
Identify emerging technologies and biomarker strategies to enhance programs.
Drive continuous improvement and adoption of digital solutions in bioanalysis.