Medical Director, Clinical Development
Core
Lead medical monitoring and clinical development strategy for Duchenne muscular dystrophy (DM1) trials, ensuring participant safety and scientific integrity.
Role type
Senior Medical Director, Clinical Development
Builds
Clinical trials for neuromuscular disease therapeutics
Domain
Biotechnology / Neuromuscular diseases
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial design, medical monitoring, safety surveillance, regulatory compliance (GCP/ICH), data interpretation, stakeholder management, scientific writing
Preferred skills
Board certification in neurology/neuromuscular disease, experience in rare diseases, knowledge of oligonucleotide therapeutics
Technologies
FDA, EMA, ICH, GCP, IND, NDA, BLA
Responsibilities
Design and implement clinical trials, serve as medical monitor for assigned studies, review clinical and safety data, support regulatory submissions, manage external collaborator relationships, provide leadership to clinical development team
Seniority
Senior, hands-on IC with leadership responsibilities