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 

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 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.