VP, Clinical Development - Infectious Disease
Tonix Pharmaceuticals
August 25, 2026
Remote friendly (Frederick, MD)
United States
Clinical Research and Development
Position Overview
- Vice President (VP), Clinical Development – Infectious Disease (reports to the Chief Medical Officer). Provide strategic oversight of clinical research, regulatory interactions, and product approvals for Infectious Diseases, initially focused on prophylactic monoclonal antibodies, live virus vaccines, and Lyme disease.
Essential Duties
- Define and lead the company’s clinical development strategy for assigned vaccines and prophylactic antibodies.
- Oversee planning, design, execution, and completion of clinical trials (Phases I-IV); develop protocols, investigator brochures, and statistical analysis plans; collaborate with Clinical Operations to ensure data quality and integrity; support scientific communications/publications; drive innovative, patient-centric, biomarker-driven trial design.
- Oversee CRO selection/management, academic partnerships, and external collaborations.
- Drive operational excellence, regulatory compliance, quality assurance, GCP adherence, ethical considerations, and scientific integrity.
- Represent the company at scientific conferences, industry consortia, and investor presentations.
- Lead Clinical Development, Clinical Operations, and Safety/Pharmacovigilance teams.
- Provide medical/scientific leadership to cross-functional teams (Medical Affairs, Regulatory Affairs, Commercial).
- Lead regulatory engagement and submissions (INDs, NDAs, BLAs, CTAs) and post-approval commitments with FDA/EMA.
- Cultivate KOL and patient advocacy relationships; build/mentor high-performing teams.
Necessary Skills and Abilities
- Demonstrated leadership of clinical development programs; strong regulatory compliance and product approval experience.
- Experience with comprehensive budget management.
Educational Requirements
- MD or DO
Experience Requirements
- 10–15 years relevant experience; progressive leadership in clinical development (Senior Director level or above).
- Infectious disease expertise; board certification in Infectious Disease a plus.
- Prior Lyme disease, live viral vaccines, and/or prophylactic monoclonal antibodies experience a major plus.
Benefits (if applicable/explicitly stated)
- Medical, Dental & Vision; life/AD&D; short- and long-term disability; flexible spending; HSA; employee assistance; pet insurance; 401k match and stock options; generous PTO/sick time/paid holidays; career development/training.
Application Instructions
- Tonix does not offer sponsorship for this role. Do not submit agency resumes unless contacted by internal Tonix Talent Acquisition.
- Vice President (VP), Clinical Development – Infectious Disease (reports to the Chief Medical Officer). Provide strategic oversight of clinical research, regulatory interactions, and product approvals for Infectious Diseases, initially focused on prophylactic monoclonal antibodies, live virus vaccines, and Lyme disease.
Essential Duties
- Define and lead the company’s clinical development strategy for assigned vaccines and prophylactic antibodies.
- Oversee planning, design, execution, and completion of clinical trials (Phases I-IV); develop protocols, investigator brochures, and statistical analysis plans; collaborate with Clinical Operations to ensure data quality and integrity; support scientific communications/publications; drive innovative, patient-centric, biomarker-driven trial design.
- Oversee CRO selection/management, academic partnerships, and external collaborations.
- Drive operational excellence, regulatory compliance, quality assurance, GCP adherence, ethical considerations, and scientific integrity.
- Represent the company at scientific conferences, industry consortia, and investor presentations.
- Lead Clinical Development, Clinical Operations, and Safety/Pharmacovigilance teams.
- Provide medical/scientific leadership to cross-functional teams (Medical Affairs, Regulatory Affairs, Commercial).
- Lead regulatory engagement and submissions (INDs, NDAs, BLAs, CTAs) and post-approval commitments with FDA/EMA.
- Cultivate KOL and patient advocacy relationships; build/mentor high-performing teams.
Necessary Skills and Abilities
- Demonstrated leadership of clinical development programs; strong regulatory compliance and product approval experience.
- Experience with comprehensive budget management.
Educational Requirements
- MD or DO
Experience Requirements
- 10–15 years relevant experience; progressive leadership in clinical development (Senior Director level or above).
- Infectious disease expertise; board certification in Infectious Disease a plus.
- Prior Lyme disease, live viral vaccines, and/or prophylactic monoclonal antibodies experience a major plus.
Benefits (if applicable/explicitly stated)
- Medical, Dental & Vision; life/AD&D; short- and long-term disability; flexible spending; HSA; employee assistance; pet insurance; 401k match and stock options; generous PTO/sick time/paid holidays; career development/training.
Application Instructions
- Tonix does not offer sponsorship for this role. Do not submit agency resumes unless contacted by internal Tonix Talent Acquisition.