Senior Director of CMC and Nonclinical Program Management

<div class="content-intro"><p data-pasted="true"><strong>About Tonix*</strong></p> <p>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.</p> <p>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.</p> <p>Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md.</p> <p>Please visit www.Tonixpharma.com for specifics on the pipeline.</p> <p>*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.</p></div><p><span style="font-family: arial, helvetica, sans-serif;"><strong>Position Overview</strong></span></p> <p><span style="font-family: arial, helvetica, sans-serif;">Tonix is seeking a full-time Senior Director of CMC and Nonclinical Program Management to lead the strategic planning and execution of development programs across Chemistry, Manufacturing, and Controls (CMC) and nonclinical functions. This role will play a critical part in driving decision-making across a complex portfolio of drug development programs, ensuring alignment between program strategy, timelines, budgets, and organizational priorities.</span></p> <p><span style="font-family: arial, helvetica, sans-serif;"><strong>Essential Duties</strong></span></p> <p style="margin: 0in; font-family: Calibri; font-size: 11.0pt;"><span style="font-weight: bold; font-family: arial, helvetica, sans-serif;">CMC and Nonclinical Program Mgt.:</span></p> <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif;">Maintain product supply (non-commercial) and establish manufacturing plans at CDMOs to support preclinical IND enabling activities and clinical studies (all phases of development).</span></li> <li style="font-size: 11pt; font-family: arial, helvetica, sans-serif;"><span style="font-family: arial, helvetica, sans-serif;">Identifies and manages program budgets and defines program‑specific development goals and objectives in alignment with the Tonix product portfolio strategy.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif;">Member of the CMC Project team meetings, both internal and at CDMOs, to ensure effective, efficient product development whilst adhering to all quality and regulatory compliance expectations by ensuring the development team are actively engaged, supporting the technical and quality team members of the project internally and in collaboration with the CDMO and associated contracts.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif;">Member of the Nonclinical Project Teams, providing project management support to ensure effective, efficient progression of studies and activities in both internal laboratories and at CROs.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif;">Assist Project Teams with stage-gate transition across key discovery and development milestones.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif;">Manage all CMC and Nonclinical regulatory interactions, ensuring source documents are available, amendments and annual reports are delivered on time.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif;">In collaboration with the internal teams, manage contract review and approval, including request for proposal/information, quarterly accruals, review percent complete vs contracts milestones, and review accuracy of invoices (including all business documentation associated with CMC and Nonclinical activities).</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif;">Oversee CMC and Nonclinical program timelines, risks, milestones, and deliverables, report updates to Senior Leadership Team including cost shifts and scope changes.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif;">Leads proactive risk identification, assessment, and mitigation activities across all program phases, ensuring alignment with the Risk Management Program and overall program success.</span></li> <li style="font-family: Calibri; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif;">Collaborate with internal stakeholders and external partners, such as regulatory agencies and contract organizations, to navigate complex development programs prior to commercialization.</span></li> <li style="font-family: Calibri; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif;">Manages relationships with Contract Manufacturing Organizations (CMOs), Contract Research Organizations (CROs), and other external partners.</span></li> <li style="font-family: Calibri; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif;">Managing multiple development programs simultaneously while reporting on deadlines and budget.</span></li> <li style="font-family: Calibri; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif;">Define, develop, and oversee comprehensive program strategies that align with organizational goals, ensuring successful drug development from discovery to commercialization and aligned with the Portfolio Mg. processes and plans.</span></li> </ul> <p style="margin: 0in; font-family: Calibri; font-size: 11.0pt;"><span style="font-family: arial, helvetica, sans-serif;"><strong>Necessary Skills and Abilities</strong></span></p> <ul> <li style="font-family: Calibri; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif;">Extensive understanding of Chemistry, Manufacturing, and Controls (CMC) processes, including drug substance and drug product development, analytical methods, formulation, manufacturing, scale-up and validation.</span></li> <li style="font-family: Calibri; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif;">Expertise in Good Manufacturing Practices (GMP), Quality by Design (QbD), regulations and guidance (FDA, EMA, ICH). Strong emphasis on maintaining product quality and compliance at every development stage.</span></li> <li style="font-family: Calibri; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif;">Experience with Module 2 & 3 regulatory content to support submissions from development through approval (IND, NDA, BLA) and lifecycle management.</span></li> <li style="font-family: Calibri; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif;">Strong mentoring and team-building skills to develop high-performing teams. Experience leading and overseeing a team of project managers, fostering development, accountability, and consistent delivery of complex programs.</span></li> <li style="font-family: Calibri; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif;">Experience in drug development processes, clinical trial design, and preclinical study design combined with strong leadership, communication, and problem-solving skills.</span></li> <li style="font-family: Calibri; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif;">Ability to align development strategies with organizational goals and industry trends; utilization of standard project management tools including (MS Project, Smartsheet, OnePager, etc.)</span></li> <li style="font-family: Calibri; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif;">Comfortable navigating uncertainty and adapting to changing priorities in a fast-paced, highly regulated environment.</span></li> <li style="font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif;">Demonstrated experience building and implementing CMC project management programs in a GxP environment with clearly defined stage‑gates, leveraging Tonix Quality and Technical Operations procedures.</span></li> </ul> <p style="margin: 0in; font-family: Calibri; font-size: 11.0pt;"><span style="font-family: arial, helvetica, sans-serif;"><strong>Education and Experience Requirements</strong></span></p> <div> <ul> <li style="font-family: Calibri; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif;">Bachelor’s degree in biochemistry, chemical engineering, microbiology, biotechnology, or related discipline, plus a Master’s/PhD in the biotechnology industry</span></li> <li style="font-family: Calibri; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif;">PMP certification preferred; alternatively, demonstrated experience successfully managing complex projects across multiple functions and program</span></li> <li style="font-family: Calibri; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif;">15 plus years’ industry experience in the biotechnology/pharmaceutical industry as a CMC project team leader or product lead</span></li> <li style="font-family: Calibri; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif;">Regulatory experience (RA in biotechnology, recommended), including submission experience with IND & NDAs)</span></li> <li style="font-family: Calibri; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif;">Program portfolio experience in both small and large molecules through all product development stages (Phase 1 through approval)</span></li> <li style="font-family: Calibri; font-size: 11pt;"><span style="font-family: arial, helvetica, sans-serif;">Experience implementing technical, strategic, and operational plans</span></li> </ul> </div><div class="content-pay-transparency"><div class="pay-input"><div class="title">Salary Range</div><div class="pay-range"><span>$223,814</span><span class="divider">—</span><span>$279,767 USD</span></div></div></div><div class="content-conclusion"><p><strong>*<span data-teams="true">Please note that Tonix does not offer sponsorship for this role.</span></strong></p> <p><strong>Recruitment & Staffing Agencies</strong></p> <p>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.</p> <p><strong>Compensation & Benefits</strong></p> <p>Tonix provides a comprehensive compensation and benefits package which includes:</p> <ul type="disc"> <li>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</li> <li>Pet Insurance</li> <li>Retirement Savings 401k with company match and annual discretionary stock options</li> <li>Generous Paid Time Off, Sick Time, & Paid Holidays</li> <li>Career Development and Training</li> </ul> <p>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.</p> <p> </p></div>