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
• 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.