Director Clinical Development

Role: Lead clinical development for global Phase 2/3 programs, overseeing trial design, conduct, and cross-functional collaboration to support NDA/BLA submissions. Responsibilities: direct scientific design of trials, serve as primary clinical representative on study teams, develop data collection and monitoring strategies, review study documentation, prepare clinical training, and engage with regulatory authorities and external stakeholders. Qualifications: PhD, PharmD, or equivalent; 8-10 years of experience in clinical research/development, managing Phase 3 studies in an FDA-regulated environment; strong knowledge of GCP and ICH guidelines; excellent communication and scientific writing skills. HighValue: late-stage clinical development, global Phase 2/3 trials, NDA/BLA readiness, cross-functional leadership, experience in Immunology and Inflammation (atopic dermatitis or alopecia areata preferred). Work setup: not specified.