(Senior) Medical Lead (F/M/D)
Core
Design, oversee, and ensure regulatory compliance of clinical trials for investigational products, focusing on participant safety and data integrity.
Role type
Senior Medical Lead (Clinical Trials)
Builds
Clinical trial protocols, safety monitoring plans, regulatory filings (CTAs, INDs, NDAs), and clinical study reports.
Domain
Pharmaceutical industry, immunology, autoimmune diseases, immuno-oncology
Deliverable
client delivery
Required skills
Medical Doctor degree, clinical trial design, regulatory compliance (FDA, EMA), safety management, data review and interpretation, cross-functional collaboration, training and support, regulatory documentation
Preferred skills
PhD, deep scientific understanding of immunology/autoimmune diseases/immuno-oncology, grant writing
Technologies
None stated
Responsibilities
Provide medical and scientific input into clinical trial protocol design; oversee clinical trials to ensure participant safety and regulatory adherence; review adverse event reports and participate in data safety monitoring board meetings; interpret clinical trial data to assess efficacy and safety; collaborate with cross-functional teams on trial objectives and regulatory discussions; train clinical research staff and investigators; prepare medical sections of regulatory documents and clinical study reports
Seniority
Senior, hands-on IC
