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, ICH). Strong emphasis on maintaining product quality and compliance at every development stage.
• Experience with Module 2 & 3 regulatory content to support submissions from development through approval (IND, NDA, BLA) and lifecycle management.
• 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.
• Experience in drug development processes, clinical trial design, and preclinical study design combined with strong leadership, communication, and problem-solving skills.
• Ability to align development strategies with organizational goals and industry trends; utilization of standard project management tools including (MS Project, Smartsheet, OnePager, etc.)
• Comfortable navigating uncertainty and adapting to changing priorities in a fast-paced, highly regulated environment.
• 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.

Education and Experience Requirements