Clinical Pharmacology Leader — Strategy & Development

Otsuka America Pharmaceutical Inc.; Indianapolis (IN); On-site; USD 231,000 - 345,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) match

Paid holidays and leave programs

Tuition reimbursement and student loan

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Clinical Pharmacology Lead to oversee pharmacology activities across all development stages. You will mentor junior scientists, drive SOPs, and align cross-functional teams with development plans.

The role requires deep PK/PD expertise, dose selection, and regulatory filings leadership, with collaboration across pharmacometrics, biomarker, and translational biology groups. Travel 20% is expected.

Qualifications

• Extensive experience developing and executing clinical pharmacology strategies for early- through late-stage programs.
• In-depth knowledge of PK/PD, biopharmaceutics, biomarkers, and related regulatory expectations.
• Hands-on PK/PD data analysis and modeling with Phoenix NLME or similar tools.
• Strong leadership and mentoring abilities with cross-functional influence.
• Experience supporting regulatory submissions (IND/NDA/BLA) and pediatrics planning.

Responsibilities

• Serve as clinical pharmacology lead on cross-functional project teams and plan optimization of strategies.
• Lead development of clinical pharmacology sections for regulatory filings and reports.
• Collaborate with pharmacometrics for model-based drug development and dose selection.
• Support biomarker development and integration into early phase studies.
• Design and review healthy subject trial protocols (FIH SAD/MAD, DDI, etc.).
• Coordinate interactions with nonclinical, regulatory, CMC, and bioanalytical teams.
• Train and mentor junior team members and drive department growth.

Skills

Leadership

Organization

Communication

Adaptability

Problem Solving

Education

PhD in Clinical Pharmacology

Tools

Phoenix NLME

Job description

Otsuka America Pharmaceutical Inc. is seeking a Clinical Pharmacology Lead to oversee pharmacology activities across all development stages. You will mentor junior scientists, drive SOPs, and align cross-functional teams with development plans.

The role requires deep PK/PD expertise, dose selection, and regulatory filings leadership, with collaboration across pharmacometrics, biomarker, and translational biology groups. Travel 20% is expected.