Executive Director, Operations Lead
Core
Lead clinical operations across the product life cycle, managing trial processes, resourcing, and team development for a biopharmaceutical company's MASH treatment.
Role type
Senior IC clinical operations executive
Builds
Clinical trials and programs for metabolic dysfunction-associated steatohepatitis (MASH) therapeutics
Domain
Biopharmaceuticals / Clinical Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical operations development, strategic planning, early to late stage clinical trial leadership, global drug development, NDA filing, protocol development, SOP creation, regulatory inspection readiness, CRO management, cross-functional collaboration
Preferred skills
Advanced degree (MS or PharmD), experience with pivotal multi-site multi-national trials
Technologies
ICH-GCP guidelines, FDA/EMA regulatory frameworks
Responsibilities
Manage clinical trial processes from planning to close-out; define tactics and manage daily operational activities; provide leadership and strategic oversight of Clinical Operations; establish performance indicators; integrate clinical operations knowledge into development plans and protocols; review and negotiate CRO proposals and investigator grant budgets; represent Clinical Operations to executive stakeholders; lead and mentor clinical operations staff; oversee quality checks and compliance with SOPs and regulations; author operational sections of protocols and investigator brochures; coordinate with Biometrics for data deliverables; support regulatory submissions and agency interactions; stay abreast of competitive regulatory and clinical practices.
Seniority
Executive Director, strategic leadership & team management