VP, Clinical Development - Infectious Disease
Listed on 2026-01-27
-
Healthcare
Medical Science, Clinical Research, Infectious Disease/ Epidemiology
VP, Clinical Development - Infectious Disease
About Tonix
Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates. The Company is focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease. In August 2025, Tonix received FDA approval for Tonmya™ (cyclobenzaprine HCl sublingual tablets), a first‑in‑class, once‑daily, non‑opioid treatment for fibromyalgia. Tonmya is the first new fibromyalgia therapy approved in over 15 years, following successful Phase 3 trials demonstrating significant symptom improvement.
Commercial launch is expected in the fourth quarter of 2025. Tonix also markets Zembrace® Sym Touch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg, both indicated for the treatment of acute migraine with or without aura in adults.
Tonix’s development portfolio includes product candidates in central nervous system (CNS), immunology, immuno‑oncology, infectious disease and rare disease. The CNS pipeline features small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. The immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer. The infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, which also serves as a live virus vaccine platform for other infectious diseases.
The rare disease portfolio includes a product in development for Prader‑Willi syndrome, with orphan drug designation and rare pediatric disease designation grants from the FDA. Tonix owns and operates a state‑of‑the‑art infectious disease research facility in Frederick, Md.
Please visit for specifics on the pipeline.
Position Overview
The Vice President (VP), Clinical Development - Infectious Disease is a leadership role responsible for guiding Tonix Pharmaceuticals' clinical development programs. Reporting directly into the Chief Medical Officer (CMO), this position provides strategic oversight to ensure excellence in clinical research, regulatory interactions and product approvals within Tonix's core therapeutic areas including CNS disorders, Transplant, Immunology and Oncology.
Responsibilities- Define and lead the company’s clinical development strategy, ensuring alignment with corporate vision and regulatory expectations with Tonix’s pipeline and therapeutic focus.
- Oversee the planning, design, execution and completion of clinical trials (Phases I–IV), ensuring efficiency, scientific rigor and compliance with regulatory standards, timelines and budgets; develop clinical protocols, investigator brochures, statistical analysis plans and other critical regulatory documents; collaborate with clinical operations to ensure the quality and integrity of clinical data; and support scientific communications and publications regarding pipeline programs.
- Drive a culture of operational excellence, regulatory compliance, quality assurance, adherence to GCP guidelines, ethical considerations and scientific integrity across Clinical Development.
- Represent the company at key scientific conferences, industry consortia and investor presentations to enhance corporate reputation.
- Provide leadership to the Clinical Development, Clinical Operations and Safety/Pharmacovigilance teams.
- Provide medical and scientific leadership to cross‑functional teams, integrating insights from Medical Affairs, Regulatory Affairs and Commercial teams to drive program success.
- Partner with R&D, Medical Affairs, Commercial and Business Development teams to align clinical development with broader corporate objectives.
- Serve as the clinical development leader for assigned pipeline programs in interactions with global regulatory agencies (FDA, EMA, etc.), ensuring effective engagement, submission strategies and post‑approval commitments; lead the preparation and review of regulatory submissions, including INDs, NDAs, BLAs and CTAs.
- Cultivate and maintain strong relationships with Key Opinion Leaders (KOLs) and patient advocacy organizations specific to the products and…
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).