Remote Associate Director, Bioanalysis & CRO Strategy

Otsuka America Pharmaceutical Inc.; Hartford (CT); Remote; USD 169,000 - 253,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) match

Paid holidays

Paid time off

Tuition reimbursement

Job summary

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

The role leads assay strategy, method development, validation and troubleshooting while collaborating with CROs and cross-functional teams to drive data integrity and regulatory readiness.

Qualifications

• Ph.D. with minimum 5 years in regulated bioanalysis or MS/BS with 8+ years.
• Expertise in regulated bioanalysis for PK and biomarker assays.
• Strong knowledge of global regulatory bioanalysis guidelines.
• Hands-on experience with LC-MS/MS, ELISA/ECL and flow cytometry.

Responsibilities

• Provide strategic and scientific leadership for outsourced bioanalytical activities.
• Oversee method development, qualification, validation and sample analysis.
• Manage CROs and external vendors to ensure timely, quality data.
• Ensure compliance with global regulatory guidance and audit readiness.

Skills

Bioanalysis leadership

Pharmacokinetics

LBA

Mass spectrometry

Regulatory knowledge

CRO management

Project management

Communication skills

Education

Ph.D.

M.S.

B.S.

Tools

LC-MS/MS

ELISA

ECL

Flow cytometry

Job description

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

The role leads assay strategy, method development, validation and troubleshooting while collaborating with CROs and cross-functional teams to drive data integrity and regulatory readiness.