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.