Remote Bioanalysis Lead & CRO Strategy (PK/Biomarkers)

Otsuka America Pharmaceutical Inc.; Montpelier (VT); A distancia; USD 169.000 - 253.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, vision coverage

401(k) match

Paid time off

Tuition reimbursement

Student loan assistance

Descripción de la vacante

Otsuka America Pharmaceutical Inc. is seeking a highly motivated Associate Director, Bioanalysis to oversee outsourced bioanalytical activities supporting clinical development, with a primary focus on PK and biomarkers.

You will lead assay strategy, method development, validation, and data interpretation, while ensuring audit-ready, submission-ready analytics and compliance across global regulations. The role requires deep expertise in LC-MS/MS, LBA, and cell-based assays, plus strong vendor

Formación

• Ph.D. or MS/BS with extensive regulated bioanalysis experience in clinical development.
• Strong expertise in PK and biomarker assays.
• Solid knowledge of global bioanalytical regulatory guidance and industry standards.
• Hands-on experience with LC-MS/MS, ELISA, ECL, and flow cytometry.
• Experience managing CROs and external partnerships, including oversight of deliverables and timelines.

Responsabilidades

• Provide strategic and scientific leadership for outsourced bioanalytical activities supporting clinical development programs.
• Oversee method development, qualification, validation, and sample analysis with troubleshooting and optimization.
• Develop and maintain partnerships with bioanalytical CROs and external vendors to ensure successful execution.
• Monitor vendor performance and ensure adherence to timelines, quality standards, and regulatory obligations.
• Ensure activities are conducted per global regulatory guidance and best practices.
• Serve as SME on project teams, offering scientific recommendations and risk assessments.
• Support regulatory submissions with review of submission-related documents and agency responses.
• Assess emerging technologies and biomarker strategies to enhance trials.
• Drive continuous improvement and adoption of new technologies and digital solutions.

Conocimientos

Bioanalysis leadership

PK & Biomarkers

LC-MS/MS

ELISA

ECL

Flow cytometry

CRO management

Project management

Communication

Educación

Ph.D. with 5+ years experience

MS/BS with 8+ years experience

Herramientas

LC-MS/MS

ELISA

Flow cytometry

Descripción del empleo

Otsuka America Pharmaceutical Inc. is seeking a highly motivated Associate Director, Bioanalysis to oversee outsourced bioanalytical activities supporting clinical development, with a primary focus on PK and biomarkers.

You will lead assay strategy, method development, validation, and data interpretation, while ensuring audit-ready, submission-ready analytics and compliance across global regulations. The role requires deep expertise in LC-MS/MS, LBA, and cell-based assays, plus strong vendor