Senior Clinical Project Manager

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® SymTouch® (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.

Please visit www.Tonixpharma.com for specifics on the pipeline.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

Position Overview

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

Essential Duties

• 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 CRO’s/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 clinicaltrials.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 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, innovation, integrity, quality, and teamwork

Necessary Skills and Abilities

• Detail oriented and organized, and adept at data entry, reporting and maintaining comprehensive records
• High level of professionalism, including meeting-presence & etiquette
• Strong communication skills (both verbal and written), able to communicate with executives and staff
• Demonstrated ability to protect and maintain confidential and personally identifiable information
• Strong knowledge of ICH GCPs
• Advanced level proficiency in Microsoft Office products. Experience with Office 365 and SharePoint is a plus.
• Willingness to learn and navigate challenges, identify a resolution and be accountable for assigned tasks
• Strong experience with clinical trial systems (EDC, TMF, CTMS, IRT systems)
• Demonstrates a high level of problem-solving skills with little to no guidance
• Ability to mentor junior staff on tasks assigned for projects, and begin to develop people management skills
• Ability to travel up to 25%, more during peak periods (e.g. site selection and initiation)
• Ability to work independently with minimal supervision

Educational Requirements

• Bachelor’s degree in life sciences or related field; advanced degree highly desirable

Experience Requirements

• Minimum 8 years in clinical operations or research with increasing levels of responsibility (e.g. clinical trial manager, clinical trial associate, clinical research coordinator, clinical research associate).
• Minimum 4 years managing clinical projects, ideally from start to end of a trial.

Recruitment & Staffing Agencies

Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes.

Compensation & Benefits

Tonix provides a comprehensive compensation and benefits package which includes:

• Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs
• Pet Insurance
• Retirement Savings 401k with company match and annual discretionary stock options
• Generous Paid Time Off, Sick Time, & Paid Holidays
• Career Development and Training

Tonix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, or any other characteristic protected by law.  In addition to federal law requirements, Tonix complies with applicable state and local laws governing nondiscrimination in employment.  This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training.  Tonix expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic, information, disability, veteran status, or any other characteristic protected by law.