VP, Clinical Development - Infectious Disease

Position Overview: Vice President (VP), Clinical Development – Infectious Disease. Reports to the Chief Medical Officer. Provides strategic oversight for clinical research, regulatory interactions, and product approvals in Infectious Diseases (initial focus: prophylactic monoclonal antibodies, live virus vaccines, and Lyme disease). Essential Duties: Define and lead the clinical development strategy for assigned vaccines and prophylactic antibodies. Oversee clinical trial planning, design, execution, and completion (Phases I–IV), including protocols, investigator brochures, statistical analysis plans, and other regulatory documents; collaborate to ensure data quality; support scientific communications/publications. Oversee selection and management of CROs, academic partnerships, and external collaborations. Drive operational excellence, regulatory compliance, GCP adherence, ethical considerations, and scientific integrity across Clinical Development. Represent the company at scientific conferences, industry consortia, and investor presentations. Lead Clinical Development, Clinical Operations, and Safety/Pharmacovigilance teams. Provide cross‑functional medical/scientific leadership (Medical Affairs, Regulatory Affairs, Commercial) and partner with R&D, Medical Affairs, Commercial, and Business Development. Lead global regulatory agency interactions (FDA, EMA, etc.) and regulatory submissions (INDs, NDAs, BLAs, CTAs) including post‑approval commitments. Maintain relationships with Key Opinion Leaders (KOLs) and patient advocacy organizations. Build, mentor, and lead high‑performing teams. Necessary Skills and Abilities: Leadership in clinical development; regulatory compliance expertise; comprehensive budget management. Educational Requirements: MD or DO. Experience Requirements: 10–15 years relevant experience with progressive clinical development leadership; Senior Director level or above experience. Board certification in Infectious Disease (plus). Expertise in infectious diseases; prior work with Lyme disease, live viral vaccines, and/or prophylactic monoclonal antibodies (major plus). Benefits (explicitly stated): Medical, dental & vision; basic/voluntary life and AD&D; short- and long-term disability; Flexible Spending; Health Savings Account; Employee Assistance; Pet Insurance; 401k with company match; paid time off, sick time, paid holidays; career development and training. #J-18808-Ljbffr Scorpion Therapeutics