Director of Clinical Pharmacology

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.