Senior Director, Clinical Pharmacology & Strategy

Otsuka America Pharmaceutical Inc.; Annapolis (MD); On-site; USD 231,000 - 345,000; Full time

Benefits offered by this job

Comprehensive medical, dental, vision,

Prescription drug coverage

401(k) match

Tuition reimbursement

Student loan assistance

Paid holidays

Job summary

Otsuka America Pharmaceutical Inc. is seeking a strategic Clinical Pharmacology Lead to oversee pharmacology activities across all stages of drug development. You will mentor junior scientists, drive SOP improvements, and guide cross‑functional teams toward regulatory submissions.

The role requires extensive experience in PK/PD, data analysis, and early‑ to late‑stage development, with strong leadership and communication skills to inform development strategies across departments.

Qualifications

• Extensive experience developing and executing clinical pharmacology strategies for early‑ through late‑stage programs.
• In‑depth knowledge of early phase study design, PK/PD, and biomarker assays.
• Hands‑on PK/PD data analysis experience including modeling tools.
• Familiarity with regulatory guidelines and cross‑functional drug development.
• Current awareness of pharmacometrics and guidance documents.

Responsibilities

• Serve as clinical pharmacology lead on cross‑functional project teams and plan strategies.
• Review and lead the development of clinical pharmacology sections for regulatory filings.
• Support model‑based drug development (MIDD) strategies and PK/PD modeling inputs.
• Collaborate with translational and biomarker teams for early phase studies.
• Mentor and develop junior team members in Quantitative Pharmacology.
• Interact with nonclinical and regulatory teams to design and report studies.

Skills

Leadership

Organization

Communication

Problem solving

Flexibility

Education

PhD in Clinical Pharmacology

Tools

Phoenix NLME

Job description

Otsuka America Pharmaceutical Inc. is seeking a strategic Clinical Pharmacology Lead to oversee pharmacology activities across all stages of drug development. You will mentor junior scientists, drive SOP improvements, and guide cross‑functional teams toward regulatory submissions.

The role requires extensive experience in PK/PD, data analysis, and early‑ to late‑stage development, with strong leadership and communication skills to inform development strategies across departments.