VP, Clinical Development - Infectious Disease

Position: Vice President (VP), Clinical Development – Infectious Disease

Responsibilities:
- 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 clinical protocols, investigator brochures, statistical analysis plans, and other regulatory documents; partner with Clinical Operations to ensure data quality and integrity.
- Select/manage CROs, academic partnerships, and external collaborations.
- Drive operational excellence, regulatory compliance, quality assurance, and adherence to GCP and ethical standards.
- Represent the company at scientific conferences/consortia and investor presentations.
- Lead Clinical Development, Clinical Operations, and Safety/Pharmacovigilance teams; provide medical/scientific leadership to cross-functional teams.
- Partner with R&D, Medical Affairs, Commercial, and Business Development to align programs with corporate objectives.
- Lead global regulatory interactions (FDA/EMA, etc.) and prepare/review INDs, NDAs, BLAs, and CTAs.
- Build relationships with KOLs and patient advocacy organizations; build/mentor high-performing teams.

Qualifications:
- Demonstrated success leading clinical development programs.
- Extensive regulatory compliance experience (interactions, submissions, approvals).
- Experience managing clinical development budgets.
- MD or DO.
- 10–15 years relevant clinical development leadership (Senior Director+ experience preferred).
- Infectious disease expertise; board certification in Infectious Disease is a plus.
- Prior Lyme disease, live viral vaccines, and/or prophylactic monoclonal antibodies experience is a major plus.

Benefits (highlights): Medical/Dental/Vision, life/AD&D, disability, FSAs/HSAs, EAP; 401k match with stock options; generous PTO/holidays; career development.

Compensation: $250,000–$350,000 USD.

Note: Tonix does not offer sponsorship for this role.