Director, Clinical Science

Role: The Director, Clinical Science leads the design, review, and interpretation of clinical studies for innovative therapies, supporting development from early phases through registration. Responsibilities include developing scientifically rigorous protocols, integrating translational and biomarker data, providing oversight during trial conduct, and contributing to regulatory documentation and interactions. The role entails cross-functional collaboration with Clinical Operations, Data Management, Biostatistics, Regulatory Affairs, and Medical Affairs, with an emphasis on data-driven decision-making and scientific leadership. Qualifications: Advanced degree (PhD, PharmD, MD, or equivalent) with 10+ years in clinical research or development within biotech or pharma, including experience leading Phase 1-3 trials. Expertise in immunology or related therapeutic areas preferred, with strong knowledge of GCP, ICH, and regulatory standards, and proficiency in clinical data review, study design, and statistical concepts. The position requires excellent scientific communication, strategic thinking, and leadership skills, capable of influencing senior teams. High-value specifics include focus on immunology, autoimmune or inflammatory diseases, with a comprehensive understanding of clinical trial methodologies, biomarker integration, and regulatory processes. The role may involve global regulatory interactions and scientific publication contributions. Work setup details and travel expectations are not specified.