Director Clinical Pharmacology

Overview

The Director, Clinical Pharmacology provides strategic scientific and technical leadership across all aspects of Clinical Pharmacology and model-informed drug development, including study strategy, pharmacokinetic (PK) and PK/PD analysis, modeling and simulation, and regulatory submissions to support early- and late-stage clinical development.

This role serves as a key cross-functional leader with regulatory affairs, clinical operations, clinical research project management, data management, biostatistics, and external partners to ensure clinical pharmacology strategies and deliverables are aligned with corporate objectives, regulatory expectations and internal standard operating procedures (SOPs). The Director leads the interpretation and integration of clinical pharmacology data into development decisions and provides strategic input into regulatory interactions with Agencies including the U.S. Food and Drug Administration (FDA). This position reports directly to the Head of Clinical and Regulatory Affairs and serves as a strategic clinical pharmacology leader within the development organization.

The Director is expected to independently lead complex development programs, influence program and portfolio strategy and contribute to organizational initiatives process improvements and scientific innovation within Clinical Pharmacology.

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. Ensure the use of validated bioanalytical methods for drug and biomarker measurement. Experience with WinNonlin is required.
• Lead collaborations with external bioanalytical laboratories, CROs, consultants, and partner organizations to ensure high-quality and timely execution of clinical pharmacology deliverables including review and approval bioanalytical validation reports and study outputs.
• 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. Experience with NONMEM/R is preferred.
• Develop and drive clinical pharmacology and pharmacometrics strategies that support scientific, regulatory, and commercial objectives across assigned programs and contribute to portfolio-level decision-making.
• Serve as the clinical pharmacology subject matter expert in regulatory interactions and lead the preparation, review, and approval of regulatory documents, including clinical study reports, protocols, investigator brochures, briefing books, IND/NDA/BLA submission content, responses to regulatory questions, presentations, abstracts, and other scientific materials.
• Maintain awareness of emerging scientific literature, regulatory guidance, and advances in clinical pharmacology and pharmacometrics, incorporating innovative approaches into study design and life-cycle management strategies where appropriate.
• Support the evaluation of compounds proposed for incorporation into transdermal systems or other formulations. Experience with transdermal drug development is preferred but not required.
• Contribute scientific and strategic expertise to business development and cross-functional teams in the scientific assessment of potential in-licensing opportunities.
• Mentor and provide scientific leadership to junior staff and cross functional team member, fostering technical development and promoting excellence within the Clinical Pharmacology function.

Qualifications

Competencies:

Education / ExperiencePh.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 programsStrong 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.CompetenciesDemonstrated scientific leadership and ability to influence to cross-functional teams and development strategy in a matrixed environment. Stron