Shape and execute clinical development strategy for assigned rare disease programs
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 clinical lead and medical spokesperson within the Global Project Team
Maintain deep expertise in internal medicine, metabolic diseases, and rare disease biology
Integrate preclinical data, clinical pharmacology, and competitive intelligence to inform strategy
Represent programs at key regulatory interactions (FDA, EMA, PMDA)
Drive timely publication of clinical data in peer-reviewed journals and at scientific congresses
Mentor junior clinical scientists and contribute to talent development within the Rare Disease TA

MD required; MD/PhD strongly preferred; medical degree from LCME-accredited or equivalent institution
5+ years in drug development in pharmaceutical/biotech industry with experience in clinical development
Demonstrated experience with orphan drug frameworks and small patient population trial design
Expertise in clinical pharmacology, biomarker strategy, benefit-risk assessment, and innovative trial designs
Proven ability to lead cross-functional global teams without direct authority; strong negotiation and decision-making skills
Exceptional written and verbal English; ability to present to scientific, regulatory, executive, and patient audiences

Clinical Research Director, Rare Disease

Key skills