Remote Associate Director, Clinical Pharmacology

Otsuka America Pharmaceutical Inc.; Raleigh (NC); Remote; USD 169,000 - 253,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) matching

Tuition reimbursement

Paid time off

Job summary

Otsuka America Pharmaceutical Inc. is seeking a senior clinical pharmacology expert to provide leadership across small and large molecule programs. The role covers study design, PK/PD analyses, and regulatory submissions in collaboration with multi-disciplinary teams.

You will contribute to first-in-human planning, mass balance studies, and cross-functional decision making while advancing pharmacometrics strategies in a remote-friendly environment.

Qualifications

• PhD, PharmD, or MS in Clinical Pharmacology (or related area) with a minimum of 4 years of industry experience within the field.
• Experience in population PK and PK/PD modeling and statistical models is a plus.
• Hands-on PK/PD analysis using software such as Phoenix NLME and R.

Responsibilities

• Supports clinical pharmacology activities related to study design, protocol development, study execution, reporting and data interpretation.
• Serves as clinical pharmacology lead on cross-functional project teams and supports model-based drug development strategies.
• Conducts translational or clinical PK and PK/PD analyses, including NCA, exposure-response, and meta-analysis.
• Authors clinical pharmacology sections in regulatory documents for filings and publications.
• Collaborates with bioanalytical and formulation groups on related development activities.

Skills

Clinical pharmacology

PK/PD analysis

PK/PD modeling

Drug development

Regulatory knowledge

Education

PhD/PharmD/MS in Clinical Pharmacology

4+ years industry experience

Tools

Phoenix NLME

R

Job description

Otsuka America Pharmaceutical Inc. is seeking a senior clinical pharmacology expert to provide leadership across small and large molecule programs. The role covers study design, PK/PD analyses, and regulatory submissions in collaboration with multi-disciplinary teams.

You will contribute to first-in-human planning, mass balance studies, and cross-functional decision making while advancing pharmacometrics strategies in a remote-friendly environment.