Director of Clinical Pharmacology Position Available In Mercer, New Jersey

EPM Scientific is currently partnered with a biopharmaceutical company is dedicated to the discovery, development, and commercialization of treatments for multiple assets and programs. With a strong foundation in neuroscience and a commitment to addressing unmet medical needs, the organization leverages cutting-edge science and a patient-focused approach to bring transformative therapies to market. Its pipeline includes both early- and late-stage assets, reflecting a strategic focus on delivering impactful solutions across a range of neurological and psychiatric conditions. The Director of Clinical Pharmacology & Pharmacometrics will lead the strategic and operational aspects of clinical pharmacology and pharmacometric activities across the drug development lifecycle. This individual will play a critical role in optimizing dose selection, trial design, and regulatory strategy through the application of quantitative pharmacology and model-informed drug development (MIDD) principles.

Key Responsibilities:

Lead the design, execution, and interpretation of clinical pharmacology studies (e.g., ADME, PK/PD, drug-drug interaction, special populations). Develop and implement pharmacometric strategies including population PK, exposure-response, and disease progression modeling. Collaborate cross-functionally with clinical development, regulatory affairs, biostatistics, and nonclinical teams to support program goals. Represent clinical pharmacology in regulatory interactions and contribute to the preparation of regulatory submissions (e.g., INDs, NDAs, briefing documents). Provide scientific leadership in the application of MIDD to inform decision-making and accelerate development timelines. Oversee external vendors and consultants involved in pharmacokinetic and pharmacometric analyses. Mentor and develop junior staff within the clinical pharmacology and pharmacometrics function.

Qualifications:

PhD, PharmD, or MD in Clinical Pharmacology, Pharmaceutical Sciences, or a related discipline. Minimum of 10 years of experience in the pharmaceutical or biotechnology industry, with a strong background in clinical pharmacology and pharmacometrics. Proven track record of successful regulatory submissions and interactions. Expertise in modeling and simulation tools (e.g., NONMEM, Monolix, Phoenix WinNonlin, R). Strong understanding of regulatory guidance and global expectations for clinical pharmacology. Excellent communication, leadership, and project management skills.