Director/Senior Director, Clinical Development

Role: Lead clinical development strategy for early-stage compounds targeting cardiovascular, metabolic, or hepatic indications, from phase 1 through regulatory interactions. Responsibilities: oversee trial design, protocol development, and study conduct; ensure compliance with GCP and FDA regulations; serve as SME for regulatory agency interactions, including responses and submissions; collaborate with cross-functional teams on lifecycle planning, data interpretation, and publication of results. Requirements: BS in Sciences with 10+ years (Director) or MS with 12+ years (Senior Director) in clinical development; extensive experience in early-phase drug development, regulatory documentation, and FDA interactions; strong knowledge of GCP, FDA regulations, and biotech/pharma environment. Preferred: experience in lipid-lowering, cardiovascular, metabolic, or hepatic therapeutic areas; translational research background; proven leadership in clinical strategy. High-Value: early clinical development, cardiovascular/metabolic/hepatic focus, regulatory expertise, GCP compliance, cross-functional leadership, remote work flexibility in the US.