Remote Bioanalysis Director: PK & Biomarkers Strategy

Otsuka America Pharmaceutical Inc.; Topeka (KS); À distance; USD 169 000 - 253 000; Plein temps

Avantages offerts par ce poste

Comprehensive benefits

401(k) match

Paid time off

Résumé du poste

Otsuka America Pharmaceutical Inc. seeks an Associate Director, Bioanalysis to provide strategic and scientific oversight of outsourced bioanalytical activities supporting clinical development, focusing on PK and biomarkers.

You will lead assay strategy, method development, validation, and data integrity for global programs. You will manage CRO partnerships, drive adoption of new technologies, and communicate complex science to cross-functional teams while ensuring compliance with global

Qualifications

• Ph.D. with a minimum of 5 years of relevant industry experience in regulated bioanalysis; or MS or BS with a minimum of 8 years.
• 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 and understanding of bioanalytical technologies, including LC-MS/MS, ELISA, ECL, flow cytometry, and other relevant platforms.
• Experience with immunogenicity assays, including anti-drug antibody (ADA) and neutralizing antibody (NAb) assays, is a plus.
• Experience managing CROs and external partnerships, including oversight of deliverables, budgets, timelines, quality, and compliance.
• Strong project management skills with the ability to prioritize and manage multiple complex programs simultaneously.
• Excellent verbal, written, and presentation skills, with the ability to communicate complex scientific information effectively to technical and non-technical stakeholders.
• Demonstrated ability to work collaboratively in cross‑functional teams and influence decision making.

Responsabilités

• Provide strategic and scientific leadership for outsourced bioanalytical activities supporting clinical development programs.
• Oversee bioanalytical method development, qualification, validation, and sample analysis activities, including scientific troubleshooting and optimization.
• Develop and maintain strong partnerships with bioanalytical CROs and other external vendors to ensure successful execution of bioanalytical strategies.
• Monitor vendor performance and ensure adherence to study timelines, quality standards, contractual obligations, and regulatory requirements.
• Ensure bioanalytical activities are conducted and documented in accordance with applicable global regulatory guidance and industry best practices.
• Serve as the bioanalytical subject matter expert on cross-functional project teams, providing scientific recommendations and risk assessments to support decision making.
• Support regulatory submissions by contributing to and reviewing submission-related documents, responses to agency questions, and inspection-readiness activities.
• Identify and evaluate emerging analytical technologies, biomarker strategies, and innovative measurement approaches that may enhance clinical development programs.
• Drive continuous improvement initiatives and champion new technologies, digital solutions, and operational efficiencies within the bioanalysis function.

Connaissances

Bioanalytical leadership

Mass spectrometry

LBA expertise

Regulatory compliance

Project management

Formation

PhD in Bioanalytical Science

MS in Chemistry

Outils

LC-MS/MS

ELISA

ECL

Flow cytometry

ADA/NAb assays

Description du poste

Otsuka America Pharmaceutical Inc. seeks an Associate Director, Bioanalysis to provide strategic and scientific oversight of outsourced bioanalytical activities supporting clinical development, focusing on PK and biomarkers.

You will lead assay strategy, method development, validation, and data integrity for global programs. You will manage CRO partnerships, drive adoption of new technologies, and communicate complex science to cross-functional teams while ensuring compliance with global