Senior Director, Clinical Pharmacology & Translational Lead

Otsuka America Pharmaceutical Inc.; Baton Rouge (LA); On-site; USD 231,000 - 345,000; Full time

Benefits offered by this job

Comprehensive medical, dental, vision

401(k) match

Paid holidays and leave

Tuition/reimbursement

Job summary

Otsuka America Pharmaceutical Inc. seeks a Clinical Pharmacology Lead to oversee clinical pharmacology activities across all stages of drug development. You will mentor junior scientists, guide SOP development, and ensure high-quality regulatory submissions.

This role partners with pharmacometrics, biomarker, and clinical development teams. The ideal candidate holds a PhD in Clinical Pharmacology with 12+ years of experience in early- to late-phase programs, and excels in data-driven decision

Qualifications

• Extensive experience developing and executing clinical pharmacology strategies for early‑ through late‑stage programs, including registrational support.
• In-depth knowledge of early phase study design, PK, PD, drug metabolism, biopharmaceutics, biomarker and bioanalytical assay in small molecule and monoclonal antibody assets.
• Hands-on experience in PK and PK/PD data analysis with Phoenix NLME.
• Excellent working knowledge of phase I clinical operations and multi‑region regulatory requirements.
• Formulation development and clinical development awareness with current pharmacology guidance.

Responsibilities

• Serve as clinical pharmacology lead on cross-functional project teams and integrate strategies into development plans.
• Review and lead development of pharmacology sections for regulatory filings (IND/NDA/BLA) and pediatrics plans.
• Collaborate with pharmacometrics and biomarker teams to support dose selection and safety assessments.
• Mentor junior scientists and oversee study design and protocols for healthy subject trials.
• Oversee interactions with nonclinical pharmacology/toxicology and regulatory teams.

Skills

Clinical Pharmacology

PK/PD Modeling

Leadership

Regulatory Submissions

Cross-functional Collaboration

Data Analysis

Education

PhD in Clinical Pharmacology

Tools

Phoenix NLME

Job description

Otsuka America Pharmaceutical Inc. seeks a Clinical Pharmacology Lead to oversee clinical pharmacology activities across all stages of drug development. You will mentor junior scientists, guide SOP development, and ensure high-quality regulatory submissions.

This role partners with pharmacometrics, biomarker, and clinical development teams. The ideal candidate holds a PhD in Clinical Pharmacology with 12+ years of experience in early- to late-phase programs, and excels in data-driven decision