Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8 mg) is the first new treatment for fibromyalgia in adults in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® Symtouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is investigating TONMYA® in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of immunology programs, including TNX-4800, a Phase 2 ready long-acting human anti- Borrelia OspA monoclonal antibody (mAb) for the prevention of Lyme disease in the U.S., and TNX-1500, a Phase 2 ready third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. In addition, the Company is progressing TNX-2900 (intranasal potentiated oxytocin), which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. To learn more, visit www.tonixpharma.com and follow the Company on LinkedIn and X .
*Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners.
Position Overview
Advance clinical research through thoughtful planning, strong partnerships, and a commitment to quality and participant safety.
The Senior Clinical Project Manager oversees and drives the execution of trials within clinical programs, including management of contract research organizations (CROs) and other service providers. This role plans, organizes, and guides trial delivery to achieve milestones on time, within budget, and within scope, in partnership with cross-functional teams.
Guided by Tonix’s core values of integrity, commitment, innovation, and passion, the Senior Clinical Project Manager brings teams together to navigate challenges, strengthen trial execution, and deliver high-quality clinical research. This role manages trial workloads and clinical operations, promotes accountability across partners, and identifies practical improvements throughout the trial lifecycle.
Key Responsibilities
Contribute to the development of study protocols, informed consent forms, and clinical program design, bringing an operational perspective to study planning.
Develop a thorough working knowledge of study protocols, investigator brochures, informed consent forms, and study-specific materials to guide effective trial execution.
Systematically evaluate and qualify CROs, vendors, and investigator sites to support study requirements and quality expectations.
Negotiate budgets and contracts and build productive relationships with third-party vendors through clear communication and shared expectations.
Lead focused project meetings and ad hoc discussions, establish clear agendas, and document decisions, meeting minutes, action items, and follow-through.
Manage vendor budgets, invoices, payments, and timelines; proactively identify and communicate anticipated budget variances.
Align study team members around priorities, resolve operational obstacles, and drive progress against study timelines and budgets.
Track, analyze, and communicate project metrics and study progress to highlight risks and support informed decisions.
Manage clinical trial registration and maintain study design, status, and results information on ClinicalTrials.gov as required.
Prepare, review, and approve study plans and manuals to support coordinated study startup.
Develop recruitment plans and materials and partner with recruitment vendors…