Senior Director, Clinical Pharmacology Strategy

Otsuka America Pharmaceutical Inc.

Providence (RI)

On-site

USD 231,000 - 345,000

Full time

14 days+

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Job summary

Otsuka America Pharmaceutical Inc. is seeking a Clinical Pharmacology Lead within the Quantitative Pharmacology team (QTR) to supervise clinical pharmacology activities across development stages and mentor junior scientists.

You will lead PK/PD analyses, support model-based drug development, and guide regulatory submissions while shaping the development strategy and cross-functional SOPs. Travel about 20% is expected.

Qualifications

PhD in Clinical Pharmacology or related field with 12+ years of relevant experience.
Experience in early-phase clinical protocol development is a plus.
Proven ability to lead cross-functional clinical pharmacology teams.

Responsibilities

Serve as clinical pharmacology lead on cross-functional project teams and plans.
Review and lead development of regulatory sections for filings and submissions.
Support model-based drug development and PK/PD analyses to inform dose selection.
Mentor junior scientists and oversee SOPs, processes and training.
Collaborate with biomarker, translational science and nonclinical teams.

Skills

Leadership experience

Clinical pharmacology expertise

PK/PD knowledge

Regulatory strategy

Cross-functional collaboration

Education

PhD in Clinical Pharmacology or related

Tools

Phoenix NLME

PK/PD modeling

Job description

You will lead PK/PD analyses, support model-based drug development, and guide regulatory submissions while shaping the development strategy and cross-functional SOPs. Travel about 20% is expected.

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