Executive Director, Clinical Pharmacology & Strategy

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

Benefits offered by this job

Medical, dental, vision coverage

401(k) match

Tuition reimbursement

Paid holidays and paid leave

Job summary

Otsuka America Pharmaceutical Inc. seeks a Senior Clinical Pharmacology Lead to guide the Quantitative Pharmacology team within QTR. You will oversee clinical pharmacology activities, mentor scientists, and drive strategy across pre-IND to phase 3 across diverse drug programs.

You will manage cross-functional interfaces with non-clinical, biomarker, and regulatory teams, shaping study designs and regulatory submissions with data-driven insight.

Qualifications

• Extensive experience leading clinical pharmacology strategies across all development stages.
• Proven ability to mentor junior scientists and manage cross-functional teams.
• Strong knowledge of PK/PD, drug metabolism, and biopharmaceutics in small molecules and mAbs.
• Familiarity with regulatory submissions and guidelines for clinical pharmacology sections.

Responsibilities

• Lead clinical pharmacology strategy and oversee PK/PD modeling activities.
• Oversee regulatory filings and pharmacology sections for INDs/NDAs/BLAs and pediatric plans.
• Collaborate with pharmacometrics, biomarker, and clinical development teams to integrate PK/PD data into drug development.
• Mentor and develop junior scientists within the Quantitative Pharmacology team.
• Review study designs and ensure cross-functional alignment across sponsors and regulators.

Skills

Scientific knowledge

Leadership

Organization

Communication

Adaptability

Education

PhD in Clinical Pharmacology

Tools

Phoenix NLME

Job description

Otsuka America Pharmaceutical Inc. seeks a Senior Clinical Pharmacology Lead to guide the Quantitative Pharmacology team within QTR. You will oversee clinical pharmacology activities, mentor scientists, and drive strategy across pre-IND to phase 3 across diverse drug programs.

You will manage cross-functional interfaces with non-clinical, biomarker, and regulatory teams, shaping study designs and regulatory submissions with data-driven insight.