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 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.

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

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