Remote Associate Director, Quantitative Pharmacology & PK/PD

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

Benefits offered by this job

Comprehensive medical coverage

Dental coverage

Vision coverage

Prescription drug coverage

401(k) match

Paid holidays and leave programs

Job summary

Otsuka America Pharmaceutical Inc. is seeking a senior clinical pharmacology professional to provide input across small and large molecule development, spanning CNS, nephrology, infectious disease, and immunology.

You will support pre-IND through IND, Phase 1–3, PK/PD analyses, and regulatory submissions, while coordinating with multi-disciplinary teams globally. The role emphasizes modeling and simulation, pharmacometrics strategy, and collaboration with bioanalytical, formulation, and

Qualifications

• PhD/PharmD/MS in Clinical Pharmacology with 4+ years industry experience.
• Experience with PK/PD modeling and population PK.
• Strong regulatory submission experience (IND/NDA).

Responsibilities

• Supports clinical pharmacology activities related to study design, protocol development, study execution, reporting and interpretation of data.
• 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 data plotting and analysis, such as NCA, exposure-response, meta-analysis.
• Works with pharmacometrics team and provides input on PK/PD analysis and reporting.
• Authors clinical pharmacology sections in regulatory documents and articles; collaborates with bioanalytical teams.

Skills

Clinical pharmacology

PK/PD analysis

Pharmacometrics

Regulatory submissions

Cross-functional collaboration

Communication skills

Education

PhD in Clinical Pharmacology

MS in Clinical Pharmacology

PharmD in Clinical Pharmacology

Tools

Phoenix NLME

R

Job description

Otsuka America Pharmaceutical Inc. is seeking a senior clinical pharmacology professional to provide input across small and large molecule development, spanning CNS, nephrology, infectious disease, and immunology.

You will support pre-IND through IND, Phase 1–3, PK/PD analyses, and regulatory submissions, while coordinating with multi-disciplinary teams globally. The role emphasizes modeling and simulation, pharmacometrics strategy, and collaboration with bioanalytical, formulation, and