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 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

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.