Senior Clinical Project Manager

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 both 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.

Finally, the rare disease portfolio includes a product in development for Prader‑Willi syndrome, which has both 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.

The Senior Clinical Project Manager is responsible for overseeing and managing trials within clinical programs. This includes the management and oversight of CROs and other service providers. The Senior CPM plans, organizes, and directs the completion of trials on time, on budget, and within scope, including overall workload and clinical management of the trials in partnership with other functional areas.

• Assist with development of the protocol and informed consent form and/or program design
• Master the basic elements of the study protocol, investigator brochure, informed consent forms, and study‑specific materials
• Evaluate and qualify CROs/vendors/investigator sites in a systematic and organized fashion
• Negotiate budgets and contracts; effectively communicate with third‑party vendors
• Lead regularly scheduled project meetings or ad‑hoc discussions with an agenda for tracking meeting minutes and action items
• Manage vendor budgets, payments, and timelines
• Coordinate with all relevant study team members to ensure studies progress on time and on budget
• Effectively track and report on internal project metrics and study progress
• Responsible for the registration and maintenance of the clinical trial design, status, and results as required by clinical trials.gov
• Prepare, review, and approve study plans and manuals for study start‑up
• Develop recruitment plans and materials; collaborate with recruitment vendors
• Plan investigator meetings (such as attendee travel, accommodations, meeting schedule, presentations, etc.) and adhere to the set budget and timeline
• Communicate study procedures, methods, and expectations to all parties
• Assure delivery and/or return of required study supplies (IP, lab supplies, etc.) to/from sites
• Oversee and approve site regulatory packages for initial drug shipments
• Attend or lead monitoring and co‑monitoring visits
• Oversee data cleaning; track the issuing and resolution of data queries
• Manage design and development of eCRFs, electronic data systems including database locks
• Maintain inspection‑ready TMF, familiarity with the TMF reference model
• Contribute to clinical study report writing and review
• Follow all established occupational health and safety procedures, good clinical practice (GCP) and standard operating procedures (SOPs)
• Oversee work of junior staff by providing guidance and constructive feedback
• Uphold company mission and values through accountability,…