Remote Senior Director, Clinical Pharmacology & PK/PD Strategy

Otsuka America Pharmaceutical Inc.; Austin (TX); Remote; USD 231,000 - 345,000; Full time

Benefits offered by this job

Comprehensive medical

Dental

Vision

401(k) match

Paid holidays

Job summary

Otsuka America Pharmaceutical Inc. seeks a Clinical Pharmacology Lead within the Quantitative Translational Research group to oversee pharmacology activities and guide department growth across all clinical stages.

You will mentor scientists, drive SOP development, and coordinate with PK/PD, non-clinical toxicology, and biomarker teams to deliver robust pharmacology strategies for dosing, exposure-response, and pediatric development.

Qualifications

• Extensive experience developing and executing clinical pharmacology strategies.
• In-depth knowledge of PK/PD, dose finding, and regulatory submissions.
• Hands-on experience with model-based drug development and BIG data analyses.

Responsibilities

• Serve as clinical pharmacology lead on multiple cross-functional project teams; plan and optimize strategies for development plans.
• Review, approve and lead development of clinical pharmacology sections for regulatory filings.
• Mentor junior scientists and oversee SOPs/working processes within QTR.
• Collaborate with pharmacometrics, biomarker and other teams to integrate PK/PD into studies.

Skills

Clinical pharmacology

Leadership

Strategic thinking

Communication

Mentoring

Cross-functional collaboration

Education

PhD in Clinical Pharmacology

Job description

Otsuka America Pharmaceutical Inc. seeks a Clinical Pharmacology Lead within the Quantitative Translational Research group to oversee pharmacology activities and guide department growth across all clinical stages.

You will mentor scientists, drive SOP development, and coordinate with PK/PD, non-clinical toxicology, and biomarker teams to deliver robust pharmacology strategies for dosing, exposure-response, and pediatric development.