Lead, Quantitative Clinical Pharmacology & PK/PD

Otsuka Pharmaceutical Co., Ltd; United States; Remote; USD 169,000 - 253,000; Full time

Benefits offered by this job

Comprehensive medical, dental, vision

401(k) match

Paid holidays and paid leave

Tuition reimbursement

Job summary

Otsuka Pharmaceutical Co., Ltd in the United States seeks a Senior Clinical Pharmacologist to lead clinical pharmacology activities across early and late development, including CNS, Infectious Disease, and immunology programs.

You will design studies, perform PK/PD analyses, author regulatory sections, collaborate with pharmacometrics and bioanalytical teams, and contribute to model-based drug development while managing budgets and timelines.

Qualifications

• PhD, PharmD, or MS in Clinical Pharmacology with 4+ years of industry experience.
• Experience in population PK and PK/PD modeling is a plus.
• Strong PK/PD analysis skills with Phoenix NLME and R.
• Knowledge of phase I operations, multi-region regulatory requirements and PK/PD modeling.
• Excellent communication and collaboration skills, written and verbal.

Responsibilities

• Support clinical pharmacology activities related to study design, protocol development, study execution, reporting and interpretation of data.
• Serve as clinical pharmacology lead on cross-functional project teams and support model-based drug development strategies.
• Conduct translational or clinical PK and PK/PD data plotting and analysis.
• Work with pharmacometrics team on PK/PD analyses and reporting.
• Authors clinical pharmacology sections in regulatory documents (IND/NDA, annual reports, pediatrics plans).
• Collaborate with bioanalytical and formulation teams on assays, biomarker development and IVIVC.
• Manage project budgets, outsourcing, SOWs and invoices.

Skills

Clinical pharmacology

PK/PD analysis

Bioanalytical chemistry

Drug metabolism

Biopharmaceutics

Education

PhD, Clinical Pharmacology

PharmD

MS in Clinical Pharmacology

Tools

Phoenix NLME

R

Job description

Otsuka Pharmaceutical Co., Ltd in the United States seeks a Senior Clinical Pharmacologist to lead clinical pharmacology activities across early and late development, including CNS, Infectious Disease, and immunology programs.

You will design studies, perform PK/PD analyses, author regulatory sections, collaborate with pharmacometrics and bioanalytical teams, and contribute to model-based drug development while managing budgets and timelines.