Senior Clinical Research Director, Rare Disease

Responsibilities

• shape and execute clinical development strategy for assigned rare disease programs
• drive programs from early development through registration with a patient-centric focus
• serve as a recognized scientific authority within the Rare Disease TA
• lead design and authorship of study synopses, CDPs, and clinical sections of IDPs
• oversee end-to-end trial execution through cross-functional units, ensuring GCP and regulatory compliance
• define and manage timelines, budgets, and risk mitigation strategies
• serve as strategic clinical lead and medical spokesperson within the Global Project Team, Protocol Review Committee and Executive Leadership
• contribute to biomarker identification and provide due diligence support for business development opportunities
• drive timely publication of clinical data in peer-reviewed journals and at scientific congresses
• align cross-functional stakeholders around a unified development vision; present CDPs to governance and senior leadership
• mentor Clinical Research Directors and 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
• 10+ years in drug development, or 10+ years pharmaceutical/biotech industry 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.