Senior Director, Quantitative Pharmacology

Location: Princeton, New Jersey, United States

Salary: $230,720–$345,000 per year, plus incentive opportunity.

Company

Otsuka is a pharmaceutical company developing and advancing medicines through clinical research, regulatory submission, and commercial development.

What you will do

• Lead clinical pharmacology activities across pre-IND, IND, and Phase 1–3 development programs for small- and large-molecule drugs.
• Develop and optimize clinical pharmacology strategies covering dose finding, dose optimization, exposure-response, pediatric development, and study design.
• Review and approve pharmacokinetic, PK/PD, clinical study, and regulatory reports and lead clinical pharmacology sections for IND, NDA, BLA, annual, investigator’s brochure, and pediatric filings.
• Serve as clinical pharmacology lead on early- and late-stage cross-functional development teams and communicate data-driven recommendations.
• Collaborate with pharmacometrics, biomarker, bioanalytical, statistics, clinical, regulatory, CMC, ADME, and nonclinical pharmacology/toxicology functions.
• Support business development evaluations, departmental strategy, SOP and working-process development, and the growth of the quantitative pharmacology function.

Requirements

• PhD in clinical pharmacology or a related field such as pharmacokinetics, pharmacology, or pharmaceutics.
• At least 12 years of relevant experience.
• Experience leading clinical pharmacology strategy, clinical study design, regulatory deliverables, and cross-functional drug development programs.
• Expertise in PK, PD, PK/PD analysis, pharmacometrics collaboration, dose selection, and model-based drug development.
• Experience mentoring and managing junior scientists and developing clinical pharmacology talent.
• Ability to travel 20–40% and work in Princeton, New Jersey.

Culture & Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.
• Company-provided life, accidental death and dismemberment, short-term disability, and long-term disability insurance.
• Tuition reimbursement and student loan assistance.
• Generous 401(k) match, flexible time off, paid holidays, and paid leave programs.
• Work focused on strategic collaboration, professional development, patient and customer centricity, and accountable leadership.