Bioanalysis Strategy Director—CRO Partnerships

Otsuka America Pharmaceutical Inc.; Santa Fe (NM); À distance; USD 169 000 - 253 000; Plein temps

Résumé du poste

Otsuka America Pharmaceutical, Inc. is seeking an Associate Director of Bioanalysis to provide strategic and scientific oversight of outsourced activities supporting clinical development, with a focus on PK and biomarker assays.

The role leads interactions with CROs, ensures audit-ready and submission-ready data, and guides assay strategy, development, validation, and troubleshooting across global projects in a fast-paced environment.

Qualifications

• Ph.D. with a minimum of 5 years of relevant industry experience in regulated bioanalysis; or MS/BS with 8+ years of relevant industry experience.
• Demonstrated expertise in regulated bioanalysis for PK 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.

Responsabilités

• Provide strategic and scientific leadership for outsourced bioanalytical activities in clinical development.
• Oversee method development, qualification, validation, and sample analysis with troubleshooting.
• Develop partnerships with bioanalytical CROs and external vendors for successful execution.
• Monitor vendor performance, timelines, quality, and regulatory compliance.
• Ensure activities align with regulatory guidance and best practices.
• Serve as SME on cross-functional teams, advising on risk assessments.
• Support regulatory submissions with documents, agency responses, and inspection readiness.
• Identify emerging technologies and biomarker strategies for program enhancement.
• Drive continuous improvement and adoption of new tech and digital solutions.

Connaissances

Mass spectrometry

LBA assays

Cell-based assays

Global regulatory knowledge

CRO/vendor management

Project management

Scientific leadership

Communication skills

Formation

PhD with 5+ years

MS/BS with 8+ years

Outils

LC-MS/MS

ELISA

ECL

Flow cytometry

Description du poste

Otsuka America Pharmaceutical, Inc. is seeking an Associate Director of Bioanalysis to provide strategic and scientific oversight of outsourced activities supporting clinical development, with a focus on PK and biomarker assays.

The role leads interactions with CROs, ensures audit-ready and submission-ready data, and guides assay strategy, development, validation, and troubleshooting across global projects in a fast-paced environment.