VP, Clinical Development - Infectious Disease

Role Summary

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 (CMO), this position provides strategic oversight to ensure excellence in clinical research, regulatory interactions, and product approvals within Tonix's core therapeutic areas including central nervous system (CNS) disorders, Transplant, Immunology and Oncology.

• Define and lead the company's clinical development strategy, 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.

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

• MD or DO required
• Board Certification in Internal Medicine and Infectious Diseases