Director, Clinical Pharmacology & Modeling

Noven Pharmaceuticals; Jersey City (NJ); Hybrid; USD 172,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) with match

Educational reimbursement

Job summary

Noven Pharmaceuticals seeks a Director of Clinical Pharmacology to provide strategic leadership across PK/PKPD analyses, modeling and simulation, and regulatory submissions for multiple development programs. This hybrid, office-based role partners with regulatory affairs, clinical operations, statistics, and external collaborators to advance drug development and life-cycle decisions.

The position emphasizes cross-functional leadership, dose selection, and integration of clinical pharmacology

Qualifications

• Ph.D. in Pharmaceutical Sciences, Pharmacokinetics, Clinical Pharmacology, or a related discipline.
• Minimum of 8-10 years of relevant experience in clinical pharmacology and/or pharmacometrics within a pharmaceutical or biotechnology R&D environment including demonstrated leadership of clinical development programs.
• Strong working knowledge of FDA, ICH, and CFR regulations and clinical pharmacology-related guidance documents.
• Demonstrated experience supporting regulatory submissions and interactions for development-stage programs.
• Demonstrated scientific leadership and ability to influence cross-functional teams and development strategy in a matrixed environment.

Responsibilities

• Provide strategic clinical pharmacology and pharmacometrics leadership to cross-functional development teams and guide the design, execution, and interpretation of clinical pharmacology studies across multiple development programs.
• Lead dose selection and optimization, dosing regimens (including special populations), and provide scientific oversight for study design in collaboration with pharmacometrics, biostatistics, and clinical colleagues.
• Oversee and/or conduct non-compartmental and compartmental analyses of clinical PK data and interpret PK and PK/PD results.
• Lead collaborations with external bioanalytical laboratories, CROs, consultants, and partner organizations to ensure high-quality and timely execution of clinical pharmacology deliverables.
• Provide strategic oversight of modeling and simulation activities, including population PK, PK/PD modeling, and clinical trial simulations, to support dose selection and study design, labeling strategies and regulatory submissions.

Education

Ph.D. in Pharmaceutical Sciences, Pharmacokinetics, Clinical Pharmacology, or related

Tools

WinNonlin

NONMEM/R

Job description

Noven Pharmaceuticals seeks a Director of Clinical Pharmacology to provide strategic leadership across PK/PKPD analyses, modeling and simulation, and regulatory submissions for multiple development programs. This hybrid, office-based role partners with regulatory affairs, clinical operations, statistics, and external collaborators to advance drug development and life-cycle decisions.

The position emphasizes cross-functional leadership, dose selection, and integration of clinical pharmacology