Senior Clinical Research Director
Core
Senior scientific and clinical leader shaping and executing clinical development strategy for rare disease programs from early development through registration.
Role type
Senior Clinical Research Director (Rare Disease)
Builds
Transformative therapies for underserved patients with rare diseases
Domain
Biopharma, Rare Diseases, Immunoscience
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical development strategy, GCP compliance, budget and risk management, biomarker identification, innovative trial design, regulatory interaction, KOL engagement, cross-functional leadership
Preferred skills
MD/PhD, Board certification in metabolic medicine/genetics/nephrology/cardiology, experience with lysosomal storage disorders/enzyme replacement therapy/gene therapy, FDA/EMA medical spokesperson experience, real-world evidence (RWE) expertise
Technologies
AI-powered research platforms, digital platforms
Responsibilities
Lead design and authorship of study synopses, CDPs, and clinical sections of IDPs; Oversee end-to-end trial execution ensuring GCP and regulatory compliance; Define and manage timelines, budgets, and risk mitigation strategies; Serve as strategic clinical lead and medical spokesperson within Global Project Team and Executive Leadership; Lead programs at key regulatory interactions (FDA, EMA, PMDA) as primary medical spokesperson; Drive timely publication of clinical data in peer-reviewed journals and at scientific congresses; Mentor Clinical Research Directors and Clinical Scientists
Seniority
Senior, hands-on IC with strategic leadership
