VP, Clinical Development - Infectious Disease
Tonix Pharmaceuticals
August 25, 2026
Remote friendly (Berkeley Heights, NJ)
United States
Clinical Research and Development
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.
Application Instructions:
- Please note Tonix does not offer sponsorship for this role.
- Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition.
- 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.
Application Instructions:
- Please note Tonix does not offer sponsorship for this role.
- Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition.