Senior Director of CMC and Nonclinical Program Management

About the role

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 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. Essential Duties CMC and Nonclinical Program Mgt.: Maintain product supply (non-commercial) and establish manufacturing plans at CDMOs to support preclinical IND enabling activities and clinical studies (all phases of development). Identifies and manages program budgets and defines program‑specific development goals and objectives in alignment with the Tonix product portfolio strategy. 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. 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. Assist Project Teams with stage-gate transition across key discovery and development milestones. Manage all CMC and Nonclinical regulatory interactions, ensuring source documents are available, amendments and annual reports are delivered on time. 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). Oversee CMC and Nonclinical program timelines, risks, milestones, and deliverables, report updates to Senior Leadership Team including cost shifts and scope changes. Leads proactive risk identification, assessment, and mitigation activities across all program phases, ensuring alignment with the Risk Management Program and overall program success. Collaborate with internal stakeholders and external partners, such as regulatory agencies and contract organizations, to navigate complex development programs prior to commercialization. Manages relationships with Contract Manufacturing Organizations (CMOs), Contract Research Organizations (CROs), and other external partners. Managing multiple development programs simultaneously while reporting on deadlines and budget. 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. Necessary Skills and Abilities Extensive understanding of Chemistry, Manufacturing, and Controls (CMC) processes, including drug substance and drug product development, analytical methods, formulation, manufacturing, scale-up and validation. Expertise in Good Manufacturing Practices (GMP), Quality by Design (QbD), regulations and guidance (FDA, EMA

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