Head of Clinical Development

• Develop programmatic clinical strategy and oversee implementation of clinical programs in line with clinical strategy while ensuring patient safety and data integrity
• Drive and/or oversee the design, execution, analysis, interpretation, and reporting of clinical studies in collaboration with R&D team members
• Lead/author clinical portions of regulatory submissions and responses to regulatory agency questions, serving as company representative for regulatory interactions
• Oversee growing internal and external clinical operations functions including cross-functional leadership with quality, CROs, regulatory, and medical writing teams

This role creates positive change by translating cutting-edge science into innovative medicines through rigorous, thoughtful and collaborative development planning and execution, ultimately developing breakthrough oral medicines that can address persistent unmet needs in chronic disease.

• M.D. or Ph.D. with 8+ years of relevant experience in biopharmaceutical industry including significant small molecule drug development experience
• Educational background in relevant scientific discipline (e.g., biology, biochemistry, immunology) with advanced degree(s) and specific therapeutic experience in immunology/inflammation
• Prior experience as a functional leader (e.g., early clinical development, clinical pharmacology, translational/experimental medicine)
• Broad understanding of biopharmaceutical drug development including working knowledge of relevant ICH and GCP guidelines and regulations

Salary range: $360,000 - $415,000. Montai Therapeutics currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits.