Clinical Pharmacology Sr. Manager

Sr. Manager of Clinical PharmacologyFull-Time with excellent benefits & incentivesWe are seeking a Sr. Manager of Clinical Pharmacology to drive the strategic development and execution of clinical pharmacology programs for small molecule assets. This role is integral in optimizing dose selection, pharmacokinetic (PK) characterization, and pharmacometric assessments to support drug development. The Director will collaborate with multidisciplinary teams across Clinical, Research, DMPK, Biometrics, Translational Medicine, Regulatory, and CMC functions to ensure seamless integration of clinical pharmacology insights into development strategies.Key Responsibilities:Develop and implement clinical pharmacology strategies from pre-IND through late-stage clinical development, ensuring optimal dose selection and risk mitigation.Design, oversee, and interpret clinical pharmacology studies, including PK and PK/PD analyses.Provide expert input on study protocols, data analysis, and regulatory submission documents (IND, NDA, IB).Collaborate cross-functionally to integrate pharmacology insights into drug development decisions.Lead interactions with regulatory authorities, responding to inquiries and contributing to health authority submissions.Manage external vendors and consultants to ensure high-quality, compliant study execution.Present clinical pharmacology findings to internal teams, senior leadership, and external stakeholders.Oncology & Inflammation background preferredQualifications:Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, or a related field.7+ years of industry or post-doctoral experience in clinical pharmacology.Strong ability to communicate complex pharmacology data effectively to diverse audiences.Experience with regulatory filings (NDA/BLA/MAA) and health authority interactions is preferred.If you are a strategic thinker with a passion for advancing drug development through clinical pharmacology, we encourage you to apply.

Created: 2025-03-08