• Directs the development of clinical strategies and for all NDA and ANDA programs.
• Oversees clinical operations and ensures successful implementation of clinical strategy.
• Orchestrates and manages clinical aspects of regulatory strategies and interactions with the Food and Drug Administration (FDA).
• Directs and oversees the analysis and interpretation of clinical trial data and the reporting of clinical trial results.
• Leads interactions with Clinical Research Organizations (CROs), investigators, and other clinical stakeholders.
• Provides clinical support and works with other members of the management team to develop and communicate the overall corporate strategy.
• Establishes and fosters partnerships with the scientific and medical community and presents clinical development progress at scientific conferences and industry meetings; Builds and maintains working relationships with key opinion leaders (KOLs), scientific advisory boards and lead clinical investigators and others; Establishes and fosters partnerships with appropriate members the scientific and medical community.
• Manages, mentors, coaches and develops direct and indirect reports.
• Collaborates with senior management as required on corporate development initiatives including, but not limited to: financing, product licensing, etc.
• Strictly adheres to ethical and good clinical practices; develops, implements and follows high standards of research and corporate conduct.
• MD or PhD AND minimum 15 years of experience in a clinical research environment (clinical practice, academic research or pharmaceutical or biotechnology department) in positions of increasing strategic, leadership and operational technical responsibility in clinical research environment.
• Proven success record in Phase 1-4 clinical research studies and trial design as well as the successful submission of Investigational New Drug Applications (INDs) and marketing approval-directed filings including but not limited to: NDAs and Marketing Authorization Applications (MAAs).
• Detailed understanding of, and exposure to, the pharmaceutical industry, including but not limited to: drug development and regulatory processes and the ability to apply that knowledge to effectively define and drive clinical development strategy.
• Proven track records of successful interactions with FDA and other health authorities.
• People management experience leading a clinical group including clinical/medical affairs and clinical operations.
• Ability to influence without direct authority.
• Clinical trial and/or clinical practice experience in pain management, neurology and/or psychiatry is a plus
• Experience supporting Attention Deficient Hyperactivity Disorder (ADHD), Central Nervous System (CNS) and/or pediatric therapeutic area is a plus.