Associate Director, Bioanalysis

Location: Remote within the United States

Salary: $169,222–$253,000, plus incentive opportunity

Company

Otsuka Pharmaceutical Companies develops pharmaceutical and healthcare solutions, with this role supporting clinical development bioanalysis.

What you will do

• Provide strategic and scientific oversight for outsourced bioanalytical activities supporting clinical development programs.
• Oversee method development, qualification, validation, sample analysis, troubleshooting, and optimization.
• Manage relationships with bioanalytical CROs and external vendors, including timelines, budgets, deliverables, quality, and compliance.
• Serve as a bioanalytical subject matter expert on cross-functional project teams and provide scientific recommendations and risk assessments.
• Support regulatory submissions, agency responses, and inspection-readiness activities.
• Evaluate emerging analytical technologies, biomarker strategies, digital solutions, and operational improvements.

Requirements

• Ph.D. with at least 5 years of relevant regulated-bioanalysis industry experience, or M.S. or B.S. degree with at least 8 years of relevant experience.
• Expertise in regulated bioanalysis supporting clinical development, including pharmacokinetic and biomarker assays.
• Strong knowledge of global bioanalytical regulatory guidance and industry standards.
• Experience with LC-MS/MS, ELISA, ECL, flow cytometry, and other bioanalytical platforms.
• Experience managing CROs and external partnerships, including deliverables, budgets, timelines, quality, and compliance.
• Strong project management, communication, presentation, collaboration, and scientific problem-solving skills.

Nice to have

• Experience with immunogenicity assays, including anti-drug antibody and neutralizing antibody assays.

Culture & Benefits

• Full-time employment with flexible time off, paid holidays, and paid leave programs.
• Medical, dental, vision, prescription drug, life, and disability insurance.
• 401(k) match, tuition reimbursement, and student loan assistance.
• Work with cross-functional stakeholders and external scientific partners in a fast-paced environment.