Director, Clinical Pharmacology

📋 Description

• • Own the clinical pharmacology strategy for a portfolio of first-in-class natural-product therapeutics advancing from IND to proof-of-concept. You will define the quantitative roadmap for dose selection, exposure-response relationships, and special-population dosing across multiple therapeutic areas including fibrosis, inflammation, and metabolic disease.
• • Design and execute adaptive Phase I trials that integrate sparse PK sampling, population PK/PD modeling, and real-time safety dashboards. Your protocols will leverage remote micro-sampling devices, wearable sensors, and cloud-based data capture to reduce patient burden while maximizing information yield.
• • Translate pre-clinical ADME data into human starting dose projections using physiologically-based pharmacokinetic (PBPK) modeling, allometry, and cross-specimal scaling. You will refine these models continuously as Phase I data emerge, ensuring that every subsequent cohort expansion is grounded in the latest evidence.
• • Serve as the single point of accountability for all clinical pharmacology deliverables: protocol synopses, statistical analysis plans, PK/PD reports, regulatory briefing books, and investigator brochures. You will orchestrate cross-functional review cycles that compress document turnaround times without sacrificing scientific rigor.
• • Build and lead a team of clinical pharmacologists, PK/PD modelers, and translational scientists. You will set hiring standards, design onboarding curricula, and create a mentorship framework that turns junior PhDs into industry-ready drug developers within 18 months.
• • Represent Enveda in scientific due-diligence discussions with potential pharma partners and investors. You will distill complex PK/PD concepts into compelling narratives that demonstrate differentiated clinical risk mitigation and accelerated development timelines.
• • Partner with the AI/ML group to embed mechanistic PK models into the company’s discovery engine. Your feedback loops will refine in-silico predictions of human clearance, volume, and bioavailability, enabling earlier go/no-go decisions on thousands of natural-product scaffolds.
• • Oversee global CRO networks for bioanalytical assay development, validation, and sample analysis. You will negotiate master service agreements, set analytical acceptance criteria, and audit data integrity to ensure every concentration-time point meets FDA and EMA standards.
• • Champion regulatory innovation by authoring IND safety sections that justify novel botanical starting doses and by preparing breakthrough-therapy briefing packages that highlight exposure-based biomarkers for accelerated approval pathways.
• • Embed pharmacokinetic literacy across the organization through quarterly lunch-and-learns, interactive R-shiny dashboards, and Slack-based Q&A channels. Your evangelism will empower colleagues in chemistry, biology, and clinical operations to make data-driven decisions autonomously.
• • Drive continuous benchmarking against industry leaders—adopting best practices from organizations like IQ Consortium and ASCPT—and then pilot next-generation methodologies such as model-informed drug development (MIDD) and physiologically-based PK for botanical mixtures.
• • Celebrate victories with a team that recently achieved unicorn status, advanced three INDs in 18 months, and was named to the Forbes AI 50 list—because every optimized dose and every regulatory milestone is a testament to collective scientific excellence.