Position Overview

The Senior Manager, Total Rewards plays a pivotal role in managing comprehensive compensation and benefits programs that align with the organization's strategic objectives within the pharmaceutical industry. This position is responsible for ensuring competitive and equitable total rewards offerings that attract, motivate, and retain top talent while maintaining compliance with regulatory requirements. This role involves collaborating closely with senior leadership, HR partners, and external vendors to develop innovative reward strategies that support business growth and employee engagement. The Sr. Manager will analyze market trends, conduct benchmarking studies, and leverage data analytics to continuously enhance the total rewards framework. Ultimately, this position drives the creation of a compelling employee value proposition through effective total rewards management that supports organizational success and workforce satisfaction.

Key Responsibilities

• Oversee compensation structures, incentive plans, engagement and retention programs that align with organizational goals and industry best practices.
• Lead market analysis and benchmarking efforts to ensure competitive positioning of total rewards offerings within the pharmaceutical sector to attract top talent and retain existing employees.
• Analyze total rewards data and prepare reports to inform decision-making and communicate program effectiveness to stakeholders.
• Ensure that the organization’s compensation and benefits programs are aligned with the company’s culture and values, contributing to employee satisfaction and engagement.
• Ensure that the total rewards programs comply with all relevant laws, regulations, and company policies.
• Drive continuous improvement initiatives by evaluating program outcomes and recommending enhancements to total rewards policies and practices.
• Manage relationships with external vendors and consultants to optimize benefits administration and compensation consulting services.
• Provide guidance and training to all leadership levels on total rewards programs and policies.
• Effectively communicate with employees to ensure they understand the value of their total rewards package.
• Manage competitive compensation and benefits programs by applying analytical and strategic thinking to market data and organizational needs.
• Hands-on ability to implement and execute Total Rewards programs aligned with leadership objectives and business needs
• Strong communication skills are essential for collaborating with leadership and HR partners to align total rewards strategies with business objectives and to effectively present findings and recommendations.
• Proficiency in regulatory knowledge ensures compliance and risk mitigation in program administration.

Qualifications

• Bachelor’s degree in human resources, business administration, or a related field
• 5+ years of progressive experience in compensation and benefits
• Strong knowledge of compensation structures, standard and fringe benefits administration, and regulatory compliance.
• Proven experience with market benchmarking, data analysis, total rewards strategy development, and equity compensation plans.
• Advance proficiency in the use of compensation and benefits software and tools.

Preferred Qualifications

• Advanced degree in human resources, business administration, or a related field
• Professional certification such as Certified Compensation Professional (CCP), Certified Employee Benefits Specialist (CEBS), or other Compensation & Benefits program(s).
• Familiarity with HRIS and total rewards technology platforms.
• Strong project management skills, with the ability to lead cross-functional teams and prioritize competing demands.
• Demonstrated leadership experience managing total rewards projects from inception to completion.
• 2+ years in a leadership role

Position Overview

Tonix is looking for a full-time Associate Director, Regulatory Affairs to effectively develop regulatory strategies and submission plans. This position would be responsible for leading regulatory activities related mainly for novel biologics or drugs in early phase development (pre-IND and nonclinical experience) to clinical development and marketing application. The Associate Director, Regulatory Affairs can work autonomously and will support all aspects of this process including early phase interactions with regulatory authorities (FDA and/or global), providing direction and actively participating in overall preparation of activities with cross-functional teams to advance the drug development program.

This is a fast-paced challenging position offering a competitive compensation and benefits package.  This position will report directly to the Co-Head of Regulatory Affairs, Management and Execution, and will be based out of a Tonix office or can be a remote based position. 

Key Responsibilities

• Act as Regulatory Lead and Manager for investigational programs in the US or global programs by providing regulatory expertise to advance product development, from nonclinical to clinical and marketing application
• Prepare, review, and co-ordinate regulatory documentation to support early phase development including early phase meetings with Regulatory Authorities and initial IND application and IND amendments to support first-in-human clinical trials
• Manage and prepare complex regulatory submissions, including drafting and review and approval of submission contents, which will require interaction with cross-functional teams and external vendors to ensure timely and quality execution
• Provide regulatory impact assessments to changes to project teams and senior management and recommend strategies and regulatory courses of action
• Follow all established occupational health and safety procedures, GxP and standard operating procedures (SOP’s)
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
• Perform ad-hoc work as necessary to support the Regulatory function and Tonix on various business initiatives

Qualifications

• Bachelor’s degree in biological or pharmaceutical sciences
• Seven (7) years of experience in pharmaceutical or health care industry experience or equivalent
• Five (5) years in early and late stage regulatory drug development
• Good scientific background and understanding of biology and immunology with the ability to acquire therapeutic area and regulatory knowledge in a short timeframe
• Knowledge of FDA and EU regulations and ICH requirements
• Proven successful leadership and project management experience
• Experience directly writing submission documents that support IND applications, clinical trials, and marketing applications
• Experience developing and implementing regulatory strategies 
• Ability to travel up to 20%
• Dedicated team player who is able to withstand the high demands of a fast-paced environment
• Strong planning and organizational skills and attention to detail with accuracy and quality
• Excellent written and verbal communication skills
• Able to work independently with minimal supervision and collaboratively with team members
• Able to effectively interact with internal and external parties to drive projects through to completion to tight timelines

Position Overview 

The Vice President (VP), Clinical Development - Infectious Disease is a leadership role responsible for guiding Tonix Pharmaceuticals' clinical development programs. Reporting directly into the Chief Medical Officer, this position provides strategic oversight to ensure excellence in clinical research, regulatory interactions, and product approvals within Tonix's core therapeutic area of Infectious Diseases, initially with focus on prophylactic monoclonal antibodies, live virus vaccines and Lyme disease. 

Essential Duties

• Define and lead the company’s clinical development strategy for assigned vaccines and prophylactic antibodies, ensuring alignment with corporate vision and regulatory expectations with Tonix’s pipeline and therapeutic focus.
• Oversee the planning, design, execution, and completion of clinical trials (Phases I-IV), ensuring efficiency, scientific rigor, and compliance with regulatory standards, timelines, and budgets. Oversee the development of clinical protocols, investigator brochures, statistical analysis plans, and other critical regulatory documents. Collaborate with clinical operations to ensure the quality and integrity of clinical data; and support scientific communications and publications regarding pipeline programs. Maintain a strong focus on innovation in clinical trial design, patient-centric approaches, and biomarker-driven strategies.
• Oversee the selection and management of CROs, academic partnerships, and external collaborations to optimize clinical trial execution.
• Drive a culture of operational excellence, regulatory compliance, quality assurance, adherence to GCP guidelines, ethical considerations, and scientific integrity across Clinical Development.
• Represent the company at key scientific conferences, industry consortia, and investor presentations to enhance corporate reputation.
• Provide leadership to the Clinical Development, Clinical Operations, and Safety/Pharmacovigilance teams.
• Provide medical and scientific leadership to cross-functional teams, integrating insights from medical affairs, regulatory affairs, and commercial teams to drive program success.
• Partner with R&D, Medical Affairs, Commercial, and Business Development teams to align clinical development with broader corporate objectives.
• Serve as the clinical development leader for assigned pipeline programs in interactions with global regulatory agencies (FDA, EMA, etc.), ensuring effective engagement, submission strategies, and post-approval commitments; lead the preparation and review of regulatory submissions, including INDs, NDAs, BLAs, and CTAs.
• Cultivate and maintain strong relationships with Key Opinion Leaders (KOLs) and patient advocacy organizations specific to the products and indications for the programs led.
• Build, mentor, and lead high-performing teams, fostering a culture of excellence, innovation, and accountability.  
• Strong ability to build and sustain meaningful relationships with KOLs, regulatory bodies, and external strategic partners.
• Exceptional leadership, mentorship, strategic planning, and operational management skills.
• Excellent communication, interpersonal, and negotiation abilities

Necessary Skills and Abilities:

• Demonstrated success in leading clinical development programs.
• Regulatory Compliance: Extensive experience with regulatory interactions, submissions, and product approvals.
• Experience in comprehensive budget management.

Educational Requirements:

• MD or DO

Experience Requirements:

• Experience: 10-15 years of relevant experience, demonstrating progressive leadership in clinical development within pharmaceutical or biotechnology companies, including prior experience serving at the Senior Director level or above in Clinical Development organizations.
• Board certification in Infectious Disease a plus
• Expertise and experience in infectious diseases.
• Prior work with Lyme disease, live viral vaccines and or prophylactic monoclonal antibodies a major plus.

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

Position Overview 

The Manager of Trade & Market Access is responsible for developing and executing programs that support patient access to Tonix’s Fibromyalgia and migraine therapies. This role blends strategic planning with hands‑on oversight to implement patient service initiatives aligned with market needs, while ensuring strong collaboration with internal teams and external partners.

Key responsibilities include managing national relationships with wholesalers, specialty distributors, and specialty pharmacies; supporting Market Access, Patient Support Services (PSS), and Trade operations; and overseeing day‑to‑day channel activities and wholesale distribution agreements. The ideal candidate is detail‑oriented, highly organized, and comfortable coordinating multiple stakeholders in a fast‑paced environment to enhance operational efficiency and improve patient access.

Essential Duties

Trade & Distribution Management

• Oversee wholesaler and specialty pharmacy activities related to sales, marketing, reimbursement, product handling, and inventory management, ensuring service excellence and timely issue resolution.
• Manage distribution contracts—including renewals, payment terms, collections, and return goods processing—in alignment with company policies.
• Collaborate with Regulatory, Finance, Manufacturing, Supply Chain, and 3PL partners to address distribution or supply chain issues.
• Monitor wholesaler performance, contract compliance, inventory levels, ordering patterns, and distribution reporting.
• Support pricing updates, chargeback reconciliation, and data accuracy across trade channels.
• Assist the Senior Director of Trade in managing wholesaler agreements and overall distribution operations.

Market Access & Patient Support Services (PSS) Operations

• Support execution and continuous improvement of Market Access and PSS operations to optimize patient access and reimbursement outcomes.
• Track and analyze KPIs related to patient access, reimbursement, and program efficiency; prepare reporting that communicates performance and business impact.
• Maintain program documentation, SOPs, and ensure compliance across Market Access and PSS initiatives.
• Contribute to hub and specialty pharmacy business reviews, including preparing materials for Quarterly Business Reviews (QBRs).
• Act as subject matter expert on hub and specialty pharmacy partners, supporting development of analytics that inform brand and leadership decisions.

Vendor Management & Operational Efficiency

• Serve as the primary day-to-day contact for Market Access and PSS vendors, ensuring adherence to service levels and timely resolution of issues.
• Support vendor performance reviews, scorecards, reporting, and cross-functional collaboration to maintain operational excellence.
• Identify workflow inefficiencies and recommend process improvements to enhance program effectiveness.
• Assist with budgeting, forecasting, and accrual tracking related to Market Access and PSS activities.

Cross-Functional Collaboration

• Partner closely with internal teams—including Trade, Field Sales, Regulatory, Finance, Supply Chain, and Market Access—to ensure aligned execution and compliance across all access, distribution, and patient support programs.
• Foster strong working relationships to support smooth program delivery and a consistent patient and stakeholder experience.

• Extensive knowledge of distribution networks, including wholesalers, specialty distributors, retail and specialty pharmacies.

• Substantial knowledge of pharmacy operations, pharmacy benefits, healthcare reimbursement practices, billing procedures, compliance, coding, and medical terminology.

• Strong understanding of programs and services to support the needs of therapy-specific patient populations.

• Familiarity with AOP process, financials, POs and budgets.

• Excellent communication and presentation skills.

• Demonstrated ability to work interdependently to promote an environment of collaboration.

• Strong familiarity with healthcare datasets (e.g., 867, 852) and government pricing regulations.

• Excellent verbal, written, and interpersonal skills with strengths in project management and issue resolution.

• Excellent verbal, written, and interpersonal skills with strengths in project management and issue resolution.

• Critical thinking, problem solving, and analytical skills.

• Ability to synthesize information and communicate with individuals at every level of the organization. 

Education and Experience Requirements

• Bachelor’s Degree from an accredited college/university 
• Minimum of 5 years of experience in Trade & Distribution within the biotech or pharmaceutical industry.

Position Overview

The Senior Director, Brand Marketing will lead the post-launch acceleration and ongoing commercialization of Tonix Pharmaceuticals’ fibromyalgia and migraine assets. This role is focused on optimizing launch performance within the first-year post-approval analyzing early trajectory, identifying opportunities to expand adoption, and evolving strategy to build sustained market momentum.

This individual will be responsible for refining brand strategy and leading execution of integrated marketing initiatives across HCP and Consumer/Patient audiences, including personal promotion, non-personal promotion, digital media, and communications/PR. A critical component of this role is developing a deep understanding of target audiences and their behaviors to drive progression up the adoption curve and expand reach within priority segments across multiple specialties.

This is a highly visible leadership role with accountability for in-market performance and cross-functional alignment across key stakeholders, including field sales, medical affairs, commercial strategy/operations, market access, and the Promotional Review Committee (PRC). The ideal candidate thrives in a fast-paced, data-driven environment and is comfortable making decisions with imperfect information to capitalize on early momentum. This position will report to the Vice President, Marketing and will be based at the Berkeley Heights, NJ office.

Essential Duties

• Monitor and assess launch performance, identifying trends, gaps, and opportunities to optimize brand trajectory
• Refine brand strategy based on real-world insights, including HCP and patient adoption patterns, barriers, and motivators
• Drive initiatives to expand awareness, trial, and adoption across priority customer segments, moving audiences up the funnel
• Lead optimization of promotional mix across personal and non-personal channels to maximize impact and ROI
• Partner with analytics and market research to generate actionable insights and translate them into strategic and tactical adjustments
• Oversee agency partners to rapidly test, learn, and scale high-performing tactics while ensuring executional excellence
• Collaborate cross-functionally with sales, medical, and market access to address barriers to uptake and align on field execution
• Mentor and lead team members while fostering a culture of agility, accountability, and continuous improvement

Necessary Skills and Abilities

• Proven ability to manage and optimize in-market brand performance, particularly in early post-launch environments
• Strong analytical mindset with ability to translate data and insights into clear actions
• Exceptional strategic agility—able to pivot quickly based on performance and emerging insights
• Deep understanding of customer segmentation, targeting, and behavioral drivers of adoption
• Excellent leadership, communication, and cross-functional influencing skills
• Strong understanding of pharmaceutical marketing, regulatory requirements, and PRC processes
• Experience working closely with field sales teams to drive execution and feedback loops
• Ability to operate effectively in a fast-paced, evolving, and performance-driven environment

Educational Requirements

• Bachelor’s Degree (BA/BS) in Business, Marketing, or related discipline required
• MBA or other advanced degree preferred

Experience Requirements

• 10+ years of pharmaceutical or biotech marketing experience
• Demonstrated success supporting or leading early post-launch brands (0–18 months post-approval)
• Experience with launch analytics, performance tracking, and optimization strategies
• Experience managing agencies and cross-functional teams in a dynamic environment
• Experience engaging with Key Opinion Leaders and driving peer-to-peer influence
• Prior pharmaceutical sales experience preferred
• CNS, primary care, rheumatology, and/or pain specialty experience preferred

Position Overview 

The Director, Commercial Operations and Analytics will be responsible for establishing and leading this critical function to ensure the efficient infrastructure, processes, and technologies necessary for the successful commercialization of Tonix’s portfolio. The near-term focus is primarily supporting the launch of TONMYA while supporting the inline migraine brands. This role is responsible for reporting commercial performance, forecasting, sales force incentive compensation, sales force sizing and targeting. Additionally, it will identify, develop and deploy enterprise functions and platform technology solutions (e.g. Veeva CRM) to maximize operational effectiveness, market access and patient services data understanding, patient level and performance data, and work closely with third party vendors such as CRM providers and data aggregators.

Essential Duties

• In collaboration with sales and marketing leadership, lead field force sizing and deployment, resource allocation, performance reporting.
• Support the building, implementation, and maintenance of sales tools, including CRM, data analytics, and sales dashboards.
• Oversee market insights, analytics and competitive intelligence to deliver data driven business recommendations.
• Lead the development of databases and infrastructure to support analytics, insights, forecasting and budgeting.
• Deliver actionable recommendations to the leadership team through analysis, market research, and competitive intelligence.
• Oversee external vendors and consultants supporting Commercial Operational platforms and resource needs for data analytics, meeting planning, competitive intelligence, IC planning, market research, and other areas as required.

Necessary Skills and Abilities

• Forecasting, Data Analytics, and Visualization
• Primary and Secondary market research
• CRM and database experience · Marketing mix and promotional response assessments
• Competent experience of using Microsoft Office products, specifically Strong MS excel skills is required

Education and Experience Requirements

• Bachelor's degree (BA/BS) 
• Master's degree (MBA, MS) preferred
• Minimum of 10 years of relevant experience, with a deep understanding of sales, marketing, and operations functions within the Pharmaceutical or Biotech industry.
• At least 5 years of management experience, leading high-performance teams across diverse functions, including Sales, Marketing, and Market Acces

Position Overview

Tonix is seeking an experienced Pharmacovigilance Scientist to join our Drug Safety and Pharmacovigilance team. Reporting to the Associate Director, Drug Safety and Pharmacovigilance this role is pivotal in ensuring the safety profiles of our products are effectively monitored and assessed. The PV Scientist will play a key role in cumulative safety data reviews, safety surveillance, and regulatory reporting.

Essential Duties

• Perform cumulative safety data reviews across trials or programs to assess safety profiles and identify emerging risks or trends
• Coordinate and document ongoing safety surveillance activities. Activities will include safety data review, signal validations, signal evaluations, literature reviews
• Lead aggregate report (PSUR/PADER/DSUR) activities, including vendor oversight and project management, database requests, data analysis, report authoring, and quality checks
• Manage literature review plan for assigned product(s) and provide feedback to vendor on routine literature surveillance activities
• Coordinate responses for ad hoc safety queries (eg, health authority requests) in collaboration with the cross functional team members, as needed. Perform safety data analyses, draft query responses, and prepare documents for cross functional review and finalization
• Represent safety at cross functional product meetings
• For investigational product(s): Support activities relevant to investigational program including (but not limited to):
• Routine/ad hoc updates to safety content of Investigator Brochure (IB), safety content of protocols, CRFs, ICFs
• Ongoing data review, including lab, vitals, ECG, and AE data review
• Review preliminary data and prepare presentations for safety review committees
• Maintain strong working knowledge of relevant regulations associated with the above activities
• Contributes to initiatives for process improvement and cross-product process consistency
• Other tasks as assigned or required

Necessary Skills and Abilities

• Demonstrated experience in analysis and interpretation of medical and scientific data and excellent verbal and written skills
• Demonstrated ability to work effectively either independently or collaboratively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues
• Demonstrated ability to prioritize multiple assignments and proactively identify solutions, as needed
• Strong organizational, project management and leadership skills: Leads and conducts (independently and/or collaboratively) all aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests.
• Scientifically sound and clinically accurate approaches to interpret data involving patient safety.
• Familiarity with pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes familiarity with case processing, expedited reporting rules, and safety database concepts
• Strong knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects), MedDRA, and Argus Safety System

Education and Experience Requirements

• Advanced degree in a relevant healthcare or life sciences field (e.g., PharmD, MD, PhD, MPH, or equivalent clinical degree such as RN or NP).
• Minimum 5 years relevant medical, scientific/clinical, or pharmaceutical experience, including 3 years of experience in drug safety serving in a PV Scientist role

Position Overview 

The National Account Director (NAD), Payers at Tonix Pharmaceuticals will be responsible for leadership and management of select national and sub-national payer and other assigned accounts. These accounts include health insurance companies, PBMs, Medicare, state Medicaid, large IDNs, among others. The NAD will be responsible for building and maintaining strong relationships with medical and pharmacy departments. This role involves executing strategies and tactics within each account, while also providing support to the sales team when necessary. A strong understanding of managed markets, reimbursement, and payer account management is essential.

The individual will effectively communicate the value of Tonix Pharmaceuticals’ product portfolio to the market, collaborate with field sales to address market access inquiries, and help develop strategies to overcome coverage barriers. Additionally, the role requires working cross-functionally with key internal teams, including Medical, Marketing, Contracting, Government Reporting, Legal, Compliance, Sales, Reimbursement, and Patient Services, to ensure cohesive execution and advocacy. This position will report directly to the Vice President, Market Access and will be based remotely. 

Essential Duties 

• Establish, broaden, and deepen relationships with target entities (e.g., health insurers, PBM’s, other payers, etc.) and key decision makers and influencers (pharmacy and medical directors, etc.) that affect coverage and reimbursement decisions.
• Positively influence decision makers, policies, guidelines and contracts to facilitate timely and appropriate coverage, access and reimbursement for our drug candidates and approved products.
• Develop account specific plans and assist in the resolution of access/reimbursement issues.
• Work closely with the MSL team to support the communication and understanding of our drug candidates and approved products with payers.
• Work closely with the Patient Services team to support the patient journey and resolve coverage issues.
• Assist Regional Sales teams with pull- or sell-through strategies based on payer coverage.
• Represent Tonix at industry events, including Asembia, AMCP, and other relevant conferences.
• Uphold the highest standards of professionalism, compliance, and ethical conduct in all internal and external interactions.

Necessary Skills and Abilities

• Self-starter and self-sufficient - able to develop account plans, hit deadlines and achieve clearly defined launch goals.
• Savvy negotiator with excellent communication, written, and verbal skills.
• Creative, strategic thinker and problem solver - able to identify, develop, and execute sound account strategies.
• Strong business aptitude / acumen and demonstrated success facilitating timely access for therapies through the ability to drive productive contract negotiations.
• Ability to work cross-functionally to proactively and reactively address access barriers.
• Competent with PowerPoint, Excel, Word, etc.
• Up to 75% travel may be required.

Educational and Experience Requirements

• Bachelor’s degree required
• Advanced degree (Master’s, Ph.D., or PharmD) preferred.
• 10+ years of biotech/pharma experience, payer understanding and experience.
• 505b2 product and migraine experience.
• Subject matter expert within the Market Access to include knowledge of pharmacy and medical benefits designs, Commercial, Medicaid and Medicare (FFS and Managed).
• Government / Federal experience preferred.

Position Overview:

The Manager, Quality Systems & Administration, situated within the Quality Assurance department, will provide support for the Veeva electronic Document and Quality Management systems (QDocs, Training, eQMS, and RIM) systems.

This position will be responsible for providing ongoing system administration, access management, configuration, and maintenance activities, as well as user support, and ensuring these systems are in an operational state of compliance associated with cGMP manufacturing environments, GxP requirements, and internal policies.

They will ensure consistent application of policies, procedures, and work instructions associated to these systems, as well as adherence to regulatory requirements.  

This position will also manage the reconciliation and archiving process of paper documents, electronic signature workflows (e.g. DocuSign), document uploads into Veeva QDocs in support of area departments as needed.

The Manager, Quality Systems & Administration will collaborate cross-functionally for on-going activities in support of continuous improvement initiatives system and workflow enhancements and assist in any other area as needed or directed by management.

Responsibilities:

• Perform Business Administrator activities in the Veeva Quality Management Systems (QDocs, Training, eQMS, & RIM), including management of user roles, permissions, and access controls.
• Provide configuration support of Veeva Vault Quality modules (e.g., QMS, Docs, Training), including management of document lifecycles, workflows, templates, and metadata.
• Participate in the assessment of impacts related to configuration changes and/or, system releases. Execute user test scripts related to system changes, as needed.
• Work with other Veeva System Leads and Veeva System Administrators to ensure continuity across workstreams
• Manage document and/or event workflows to support end users.
• Manage and/or support electronic signature workflows and envelopes (e.g. DocuSign), and document uploads into Veeva QDocs in support of area departments as needed.
• Support user training sessions, onboarding, and refresher training for Veeva Vault applications. Assign and/or revise user training plans and curricula in alignment with area department needs, as appropriate.
• Support the reconciliation and archiving process of paper documents.
• Identify opportunities to enhance system usability, workflow efficiency, and user experience.
• Perform other projects related to the improvement of quality systems as needed and required by management, including the Veeva eQMS system.
• Participate in regulatory inspection, internal audits, supplier audits (as needed), and audit response activities.
• Ensure compliance with all applicable policies, procedures, and regulatory requirements

Necessary Skills and Abilities:

• Veeva Vault Certification (Administrator, Quality Suite) or equivalent SME-level experience administering and configuring Veeva Vault is required.
• Working knowledge of GxP processes associated with Veeva Quality Docs, Training, eQMS, and RIM applications (e.g., document change control, training, deviation management & CAPA).
• Proficiency in Microsoft office applications, including formatting of MS Word document & Excel spreadsheets.
• Strong documentation, organization, and communication skills; ability to collaborate effectively with technical and non-technical stakeholders
• Dedicated team player who is able to withstand the high demands of a fast-paced environment.
• Excellent planning and time management skills and the ability to handle several tasks simultaneously.
• Comfortable working independently with minimal supervision.
• Strong troubleshooting and problem-solving skills.
• Excellent communication skills with the ability to collaborate across functional teams Must lead by example through strong work ethics and high standards.
• Ability for travel up to 10% of the time

Qualifications

• Bachelor’s degree or higher.
• 8+ years of experience in the biotech/pharmaceutical industry, with a minimum of 4 years situated within a Quality Management Systems function or equivalent.
• Extensive experience in Veeva Vault Systems Administration and configuration.
• Experience with previous implementation of Veeva Vault platforms and systems migration.

Preferred:

• Experience in managing a document archival room and coordination with off-site storage procedures.
• Experience in executing test scripts to support system updates and releases.
• Experience with Veeva PromoMats, and/or other EDMS/QMS/LMS systems.

Position Overview

The Senior Specialist, Regulatory Operations, will be responsible for submission management across the development pipeline and support the commercial portfolio. This hands-on position will also assist with regulatory affairs systems, applications, and tools including supporting system implementations, maintenance, updates, and releases.

You’ll work closely with Regulatory Affairs and cross-functional partners to manage timelines, ensure submission readiness, and strengthen operational excellence across the organization. This position will report directly to the Senior Director of Regulatory Affairs and will be based out of a Tonix office or can be a remote based position. 

Essential Duties

• Lead end-to-end management of regulatory submissions, ensuring timely, compliant, and high-quality deliverables.
• This role interfaces with external publishing vendor(s) for the preparation of submissions, and internal stakeholders to provide operational oversight and support for eCTD regulatory submission activities.
• Serve as submission manager and primary contact for publishing vendors and internal stakeholders.
• Oversee regulatory document management, tracking, and archival activities.
• Manage regulatory systems (e.g., Veeva RIM, PromoMats), and serve as internal subject matter expert (SME) for training and support to internal stakeholders
• Develop and implement processes, templates, and tools that improve submission efficiency and consistency.
• Partnering with IT to maintain the regulatory technology landscape including maintenance, updates, and releases.
• Provide subject matter expertise on regulatory technologies and submission best practices.
• Monitor new regulations and industry trends to assess impact on operational practices.
• Any other supporting activities or research, as needed, for the regulatory team.

Necessary Skills and Abilities

• Experience managing outsourced publishing vendors a plus.
• Skilled at balancing strategic oversight with hands-on execution.
• Strong communicator and collaborator with excellent organizational skills.
• Ability to travel 10% of the time

Educational Requirements

• Bachelor’s degree in a scientific or related field.

Experience Requirements

• 3-4 years of regulatory operations experience in biotech or pharmaceutical industry.
• Strong understanding of eCTD submission standards and regulatory requirements across global regions.
• Proven experience with IND/CTA and NDA/MAA submissions, including lifecycle management.
• Hands-on experience with Veeva RIM and/or PromoMats strongly preferred.

The Human Resources Business Partner (HRBP) serves as a strategic advisor to business leaders, aligning talent strategy with business objectives to drive performance, engagement, and organizational effectiveness. This role partners with leadership across corporate, R&D, clinical, regulatory, manufacturing, and/or commercial functions in a fast-paced, science-driven environment.

Responsibilities

• Serve as a trusted advisor to functional leaders on organizational design, workforce planning, talent strategy, and change management.
• Partner with leadership to drive performance management, succession planning, and talent development.
• Coach managers on employee relations, engagement, and leadership effectiveness.
• Lead compensation planning, workforce budgeting, and headcount strategy in partnership with Finance.
• Ensure compliance with federal, state, and local employment laws.
• Support culture-building efforts aligned with company values.
• Leverage HR data and analytics to inform decision-making.
• Partner cross-functionally with Talent Acquisition, Total Rewards, and HR Operations.

Supervisory Responsibilities:

Directly supervises employees. Responsibilities include hiring, onboarding, performance management, coaching, feedback, and day‑to‑day people leadership in accordance with company policies and employment laws.

Qualifications

• Bachelor’s degree in HR, Business, or related field.
• 8+ years of progressive HR experience, including HRBP experience.
• Experience in biotech, pharma, or life sciences required.
• Strong expertise in organizational design preferred.
• Demonstrated ability to influence without authority.
• Strong executive presence and business acumen with demonstrated success supporting leaders in high-growth environments.
• Proven ability to lead through ambiguity and organizational growth.

Position Overview

The Information Technology Specialist provides system support across multiple IT functional areas, including but not limited to technical and operational support, application support, and system management. This role is responsible for planning, coordinating, implementing, modifying, and troubleshooting IT-related solutions to meet business needs. This position supports both onsite and remote corporate users and requires the ability to communicate complex technical information clearly to non-technical audiences.

Essential Duties

• Helpdesk Support (Onsite and Remote)
• Provide tier I and II support; escalate tickets to supervisor as needed
• Install, configure, and maintain computer systems and software
• Support onboarding and offboarding of employees, including system access and equipment setup
• Manage user accounts, permissions, and access controls
• Relocating equipment for employees and laboratories
• Support Audio/Visual technologies in common areas
• Manage and maintain inventory of IT equipment and software licenses
• Trace and patch ethernet cables
• Ticketing System
• Work within IT ticketing system to document procedures, system configurations, and technical issues
• Track support tickets from creation through resolution, ensuring timely closure and proper documentation
• Maintenance and Support for IT equipment
• Assist with hardware and software upgrades, updates, and patching
• Coordinate support calls with 3rd party vendors
• Monitor warranties and maintenance agreements on physical IT equipment
• Compliance and Professional Standards
• Follow all established occupational health and safety procedures, Good Manufacturing Practices (GMP’s) and Standard Operating Procedures (SOP’s)
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
• Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Necessary Skills and Abilities

• Dedicated team player able to thrive in a fast-paced, high-demand environment
• Comfortable working independently with minimal supervision
• Ability to adapt and use problem solving skills to resolve real time issues
• Excellent written and verbal communication skills are essential
• Strong planning and organizational skills
• Highly organized, results driven, problem solver, and collaborator
• Demonstrate ability to perform the essential duties of the position with or without accommodation
• Excellent customer service and soft skills when working with and responding to end user needs and questions

Educational Requirements

• Bachelor’s degree in computer science or 4 years of relevant experience preferred

Experience Requirements

• Ability to diagnose and troubleshoot basic technical issues across hardware, software, and network environments
• Basic proficiency in PC and laptop hardware, operating systems, software applications, telecommunications, and networking concepts
• Working knowledge of DNS, DHCP, Active Directory (AD), and basic network infrastructure
• Ability to safely lift, move, and install IT equipment weighing up to 50 pounds
• Ability and willingness to travel occasionally, as required

Position Overview

The Director, Regulatory Affairs for Infectious Diseases will serve as the primary Regulatory Lead for Tonix’s infectious disease biologics programs. This role oversees global regulatory strategy, submissions, health authority interactions, and cross‑functional leadership from early development (nonclinical, pre‑IND) through clinical stages. The ideal candidate is proactive, strategic, and comfortable operating with minimal oversight while driving timelines and influencing team direction. This position will report directly to the Head of Regulatory Affairs and will be based at a Tonix office or can be a remote-based position.

Essential Duties

• Serve as Regulatory Lead for biologics, focused on infectious diseases programs.
• Develop and execute global regulatory strategies across nonclinical, CMC, and clinical development.
• Lead preparation, authorship, and coordination of regulatory submissions, including pre‑IND packages, INDs, amendments, and briefing documents.
• Direct interactions with FDA and other health authorities; prepare teams, lead discussions, and manage responses to queries.
• Lead cross‑functional regulatory efforts by partnering with nonclinical, CMC, clinical, project management, and external partners/CROs.
• Assess regulatory risks, impacts, and mitigation options; communicate recommendations to internal teams and senior leadership.
• Ensure compliance with FDA, ICH, and global regulatory requirements, as well as internal SOPs and GxP standards.
• Oversee regulatory documentation quality and timely delivery of program milestones.

Necessary Skills and Abilities

• Strong scientific foundation in immunology, infectious diseases, or related biological disciplines.
• Proven experience preparing and submitting INDs and related early‑phase regulatory documents.
• Demonstrated ability to independently lead regulatory strategy and cross‑functional teams.
• Strong knowledge of FDA, ICH, EU, and applicable global regulatory guidelines.
• Excellent written and verbal communication skills, including regulatory writing and team communication.
• Strong organizational, planning, and prioritization skills with high attention to detail.
• Ability to manage multiple responsibilities in a fast‑paced, dynamic environment.
• Ability to work independently with minimal oversight while collaborating effectively across functions.
• Ability to travel up to 20%.

Educational Requirements

• Bachelor’s degree in biological sciences, pharmaceutical sciences, or related field; advanced degree preferred.

Experience Requirements

• 10–12+ years of progressively responsible regulatory experience with demonstrated program leadership.

Position Overview

Tonix is seeking a highly motivated and innovative Principal Scientist with a background in immunology, autoimmunity or oncology to contribute to research and development across our growing immunology portfolio. This is an excellent opportunity to directly participate and obtain exposure to the end-to-end product development process including early-stage therapeutic discovery, nonclinical safety and pharmacological evaluation, cGMP manufacturing and clinical evaluation. The candidate will have a Ph.D. or M.D./Ph.D. in a relevant field, a strong publication record, and experience working in an interdisciplinary team environment.  The position is located at the Tonix Research and Development Center (RDC) which is the innovation and development arm of Tonix Pharmaceuticals.  The RDC houses state-of-the-art equipment (i.e., high content imaging, mass spectrometry, spectral flow cytometry, multi-parallel bioreactors, etc.) and is responsible for development of efficient and cutting-edge treatment methods for various diseases including infectious diseases, oncology, and other indications.  This position will require an in-depth knowledge of in-vivo immunology and/or virology; will involve organizing and implementing complex research plans, developing methods of testing, data collection and analysis; and will involve writing reports containing descriptive, analytical, and evaluative content. The duties will also require the exercise of independent discretion and judgment in carrying out research activities within the predetermined research scope.  Experience in the composition of scientific publications, research program technical reports, and research grants is required.

Key Responsibilities

• Establish and maintain a robust flow cytometry pipeline to support in-depth immunology research. 
• Conduct independent and original research supporting the Tonix portfolio and RDC mission
• Develop novel methods and assays to contribute to the RDC research pipeline
• Establish in-vitro and in-vivo models to support evaluation of immunotherapeutics against diverse disease conditions (e.g., autoimmunity, oncology)
• Collection, analysis, and evaluation of data
• Interpret data, make decisions, and conduct troubleshooting on related technical issues
• Preparation of scientific presentations, reports, manuscripts, and grant proposals

This is a fast-paced challenging position offering competitive compensation and benefits package.  This position will report to the Director of Immunology and will be based at the Tonix Research and Development Center in Frederick, Maryland.

Essential Duties & Responsibilities

• Design, optimize, and standardize novel in-house flow cytometry assays, ensuring consistent reliability and reproducibility of screening outcomes.
• Establish multi-parameter flow cytometry panels using spectra flow cytometry and define data acquisition and analysis pipelines to support RDC programs
• Provide scientific leadership and expertise in cell-based, molecular, and biochemical assays, while ensuring rigorous experimental data analysis.
• Independently troubleshoot, problem-solve, and execute experiments, while effectively incorporating feedback and adapting to evolving project needs.
• Work cross-functionally in a matrix environment, partnering with project and functional teams to drive research objectives forward.
• Characterize and assess binding properties of novel proteins and antibodies using cutting-edge technologies, including Octet, high-content plate-based imaging, and novel reporter-based assays.
• Lead and participate in cross-functional project teams, proposing innovative discoveries and optimization strategies that align with industry’s best practices.
• Integrate cross-functional inputs to develop a robust, strategic R&D plan, ensuring alignment with Tonix’s innovation goals.
• Uphold company mission and values, emphasizing accountability, innovation, integrity, quality, and teamwork.
• Support special projects and business initiatives as needed to contribute to Tonix's broader corporate strategy.

Minimum Qualifications

• Ph.D., or equivalent doctoral degree 
• Strong accomplishment record demonstrating the ability to perform independent, high-quality, creative, and impactful research in the field of application of viral vectors as vaccines against deadly pathogens and antibody or protein design and discovery
• Ability to generate hypothesis to test ideas, use the data set to evaluate hypothesis, and design new studies 
• Ability to apply multiple cutting-edge techniques for drug screening, such as high-content imaging, microscopy, and cell-based screening
• Sound working experience in industry or biological context, and the ability to interrogate large data sets using computational tools and application of bioinformatic to dissect complicated data sets such as high throughput data a plus
• Ability for minimal travel
• Dedicated team player who can withstand the high demands of a fast-paced environment
• Excellent written and verbal communication skills are essential
• Strong planning and organizational skills
• Comfortable working independently with minimal supervision
• Highly organized, results-driven, problem solver, and collaborator
• Demonstrated ability to perform the essential duties of the position with or without accommodation

Position Overview

The Associate Director Thought Leader Liaison (TLL), Fibromyalgia, will directly report into the Director, Commercial Strategy and will lead executional efforts in regional and local engagement with existing and emerging Key Opinion Leaders (KOLs), Advocacy Groups and Professional Societies to develop and implement education that helps simplify the early Fibromyalgia patient journey from diagnosis through treatment and monitoring. This will include identifying new and emerging opinion leaders and appropriately engaging KOLs to support speaker bureau activities, and assessing speaker programs for meaningfulness, effectiveness, education, and compliance with company policies. 

The TLL role is a field-based role (non-sales focused) position, working closely with U.S. Key Fibromyalgia Thought Leaders (KOLs) to ensure cross-functional commercial resources are made available as appropriate.  The three primary (but not exclusive) areas of focus for TLL are KOL engagement, executive encounter management, and supporting the Fibromyalgia community. 

Essential Duties

• KOL engagement – identify, profile, and maintain long-term relationships with KOLs in the Fibromyalgia community
• Engagement with national, regional, and local thought leaders, including emerging thought leaders, to identify and seek insight regarding best practices that can help simplify the patient journey
• Identification and implementation of training (product, disease state, and compliance training) for promotional speakers and related aspects of speaker programs
• Collaboration with Promotional Program Manager for speaker usage and issues
• Provide feedback regarding nomination of new speakers, when applicable
• Coordinate/facilitate new product and annual compliance training for speakers
• Work with Marketing team for annual speaker re-contracting
• Update and track KOL engagements via KOL management platform in partnership with operations lead
• Collaborate appropriately with field teams to enable local/account-level engagement with national, regional, and emerging thought leaders
• Facilitate coordination of KOL engagements at the local level
• Coordinate with field sales team, brand leads, and speaker program vendor on speaker availability and utilization  
• Ensure appropriate pull-through of speaker programs within allocated regional budgets
• Solicit, understand, and relate field feedback regarding promotional programs
• Identify potential opportunities for institutional group training
• Identify, assess, and appropriately engage with regional advocacy groups and local/regional professional societies, in collaboration with Corporate Advocacy, to develop and implement Fibromyalgia education that helps simplify the patient journey (above-brand), from diagnosis through patient monitoring
• Serve as a central point for field engagement with regional/local advocacy and professional societies
• Synthesize learnings, translate them into key insights and best practices, and regularly present these insights to Marketing and Sales leadership to help inform brand strategy, messaging, educational initiatives, and promotional programs
• Understand what KOLs are communicating through publications, congresses, podium presentations, and 1:1 interactions
• Remain on the cutting edge of data readouts (consistent with FDA-approved labeling, medical congress meeting outputs, and podium & symposia presentations)
• Engage with KOLs affiliated with key regional health systems to understand best practices for establishing diagnostic and treatment algorithms
• Help develop case studies and share with health system C-suite to encourage adoption of Fibromyalgia care pathways and treatment algorithms
• Support execution of commercial contracts, as needed

Necessary Skills and Abilities

• Demonstrated leadership skills and Self-starter with strong clinical acumen
• Strong communication and presentation skills with ability to tailor content to diverse audiences 
• Demonstrated analytical and problem-solving skills
• Understanding of legal and regulatory issues impacting pharmaceutical product marketing, as well as the dynamics driving the U.S. healthcare environment
• Proven ability to function autonomously 
• Open, collaborative nature with ability to rapidly integrate and motivate cross-functional team members and stakeholders
• High learning agility
• Ability to thrive in a rapidly evolving, complex, fast-paced environment
• Excellent verbal, written, and interpersonal skills, as well as emotional intelligence
• Demonstrated ability to establish and maintain strong business relationships
• Commitment to corporate culture of patient-centricity, innovation, and compliance

Educational Requirements

• BA/BS required; advanced degree preferred

Experience Requirements

• Minimum of 10 years’ experience in pharmaceutical/healthcare field
• Thought Leader Liaison/KOL Engagement experience strongly preferred
• In-depth knowledge of integrated health systems operations within current market environment
• Experience in Rheumatology, Pain, Neurology, Psychiatry are preferred
• Travel requirements: Overnight domestic travel expected for meetings with KOLs, Advocacy Groups and Professional Societies, as well as conferences.  Includes some weekend travel.  Willingness to travel up to 75%
• As a condition of employment and an essential function of the position, applicants must be able to engage in person with HCPs and other third parties at their offices, institutions, and other appropriate locations on a regular basis.  In order to gain in-person access, applicants selected for the position may be required to complete third parties’ credentialing and/or entry requirements, which often include an attestation to and/or providing proof of having received certain vaccinations.  To the extent you are unable to meet certain requirements for qualifying medical (including pregnancy-related) or religious reasons, applicants must request reasonable accommodation by contacting the Human Resources Department.

Position Overview

Tonix Research and Development Center is seeking an experienced Scientist with expertise in novel animal model development for immunologic and infectious diseases, oncology, biological and vaccine development in order to advance the pipeline of novel therapeutics and vaccines in Tonix’s preclinical research portfolio.  The successful candidate will leverage their extensive experience in in vivo research to design, implement, and validate translational animal models, integrate advanced physiological monitoring tools, and ensure the highest standards of biosafety and personnel safety in the laboratory.

Key Responsibilities

Animal Development & Research 

• Lead the design, development, and standardization of innovative animal models for various disease indications such as autoimmune and oncology, supporting Tonix programs such as TNX-4200, TNX-4300, TNX-1500, TNX-1700, TNX-801, and other pipeline programs.
• Develop models that closely replicate human disease to support translational research and regulatory submissions.
• Evaluate and compare exposure and administration routes (intramuscular, intravenous, intratracheal, intrabronchial, tumor implantation, etc.) for pathogenesis, efficacy, and safety testing.
• Integrate telemetry, plethysmography, imaging, tumor growth monitoring, and other advanced physiological monitoring technologies into animal studies.
• Conduct natural history, proof-of-concept, survival, and pathogenesis studies under regulatory-compliant conditions.
• Conduct test article efficacy evaluation, pharmacokinetics/pharmacodynamics, and toxicologic studies in support of investigational new drug enabling activities throughout Tonix’s portfolio

Necessary Skills and Abilities

• Demonstrated expertise in developing and standardizing models which mimics human diseases such as infectious diseases and disorders of immune system,
• Proficiency in microbiological, immunological, and molecular assay techniques (e.g., ELISA, plaque assays, RT-PCR, flow cytometry).
• Experience as a PI or Study Director for in vitro and animal experiments.
• Strong technical writing, presentation, and data analysis skills.

Educational and Experience Requirements

• M.S. in Biotechnology, Biology, or related life sciences discipline (Ph.D. preferred).
• Minimum 10 years’ experience in biomedical research