Director Clinical Pharmacology

Role: The Director, Clinical Pharmacology provides strategic leadership in clinical pharmacology and model-informed drug development for early and late-stage programs. Responsibilities: lead study design, PK/PD analysis, modeling and simulation activities, dose optimization, and regulatory submissions; oversee collaborations with CROs and bioanalytical labs; contribute to regulatory interactions and scientific literature integration; mentor junior staff; support business development via scientific assessments. Qualifications: Ph.D. in Pharmaceutical Sciences, Pharmacokinetics, or related, with 8-10+ years in pharmaceutical R&D; expertise in clinical pharmacology, pharmacometrics, and regulatory guidance (FDA, ICH, CFR); proven leadership in complex development programs and regulatory interactions; strong analytical, strategic, and scientific writing skills; experience with PK modeling software (WinNonlin, NONMEM/R preferred). High-Value: focus on innovative clinical pharmacology strategies supporting development and regulatory milestones, potentially including transdermal drug formulations; cross-functional stakeholder engagement; primarily office-based with hybrid work setup; no travel specified.