VP, Clinical Development - Infectious Disease
Tonix Pharmaceuticals
August 31, 2026
Remote friendly (Frederick, MD)
United States
Clinical Research and Development
Position Overview
Vice President (VP), Clinical Development - Infectious Disease (reporting to the Chief Medical Officer). Provides strategic oversight for Infectious Diseases clinical development programs, initially focused on prophylactic monoclonal antibodies, live virus vaccines, and Lyme disease.
Essential Duties
- Define and lead clinical development strategy for assigned vaccines and prophylactic antibodies.
- Oversee planning, design, execution, and completion of Phase I-IV clinical trials; develop key regulatory documents (protocols, investigator brochures, statistical analysis plans); collaborate with Clinical Operations 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.
- Represent the company at scientific conferences, industry consortia, and investor presentations.
- Provide leadership to Clinical Development, Clinical Operations, and Safety/Pharmacovigilance teams.
- Provide medical/scientific leadership to cross-functional teams to drive program success.
- Lead global regulatory agency interactions (FDA, EMA, etc.), including preparation/review of INDs, NDAs, BLAs, and CTAs.
- Build relationships with Key Opinion Leaders (KOLs) and patient advocacy organizations.
- Build, mentor, and lead high-performing teams.
Necessary Skills and Abilities
- Demonstrated success leading clinical development programs.
- Extensive regulatory compliance experience (interactions, submissions, approvals).
- Experience with comprehensive budget management.
Educational Requirements
- MD or DO.
Experience Requirements
- 10–15 years relevant experience with progressive leadership in clinical development (Senior Director+ preferred).
- 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).
Application Instructions
- Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition; do not forward resumes to Tonix employees or other locations.
Compensation & Benefits
- Medical, Dental & Vision; life/AD&D; short- and long-term disability; Flexible Spending/Health Savings Accounts; Employee Assistance Programs; Pet Insurance; 401k with match and annual discretionary stock options; Paid Time Off, Sick Time, and Paid Holidays; Career Development and Training.
Vice President (VP), Clinical Development - Infectious Disease (reporting to the Chief Medical Officer). Provides strategic oversight for Infectious Diseases clinical development programs, initially focused on prophylactic monoclonal antibodies, live virus vaccines, and Lyme disease.
Essential Duties
- Define and lead clinical development strategy for assigned vaccines and prophylactic antibodies.
- Oversee planning, design, execution, and completion of Phase I-IV clinical trials; develop key regulatory documents (protocols, investigator brochures, statistical analysis plans); collaborate with Clinical Operations 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.
- Represent the company at scientific conferences, industry consortia, and investor presentations.
- Provide leadership to Clinical Development, Clinical Operations, and Safety/Pharmacovigilance teams.
- Provide medical/scientific leadership to cross-functional teams to drive program success.
- Lead global regulatory agency interactions (FDA, EMA, etc.), including preparation/review of INDs, NDAs, BLAs, and CTAs.
- Build relationships with Key Opinion Leaders (KOLs) and patient advocacy organizations.
- Build, mentor, and lead high-performing teams.
Necessary Skills and Abilities
- Demonstrated success leading clinical development programs.
- Extensive regulatory compliance experience (interactions, submissions, approvals).
- Experience with comprehensive budget management.
Educational Requirements
- MD or DO.
Experience Requirements
- 10–15 years relevant experience with progressive leadership in clinical development (Senior Director+ preferred).
- 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).
Application Instructions
- Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition; do not forward resumes to Tonix employees or other locations.
Compensation & Benefits
- Medical, Dental & Vision; life/AD&D; short- and long-term disability; Flexible Spending/Health Savings Accounts; Employee Assistance Programs; Pet Insurance; 401k with match and annual discretionary stock options; Paid Time Off, Sick Time, and Paid Holidays; Career Development and Training.