Note: The job is a remote job and is open to candidates in USA. Tonix Pharmaceuticals is a fully integrated biotechnology company focused on commercializing and developing therapeutics to treat and prevent human disease. The Vice President of Clinical Development for Infectious Disease will lead clinical development programs, overseeing clinical trials and ensuring regulatory compliance while collaborating with cross-functional teams and external partners.
Responsibilities
- 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
Skills
- MD or DO
- 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
- Demonstrated success in leading clinical development programs
- Extensive experience with regulatory interactions, submissions, and product approvals
- Experience in comprehensive budget management
- Exceptional leadership, mentorship, strategic planning, and operational management skills
- Excellent communication, interpersonal, and negotiation abilities
- 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
Benefits
- Medical, Dental & Vision Insurance
- Basic and Voluntary Life and AD&D Insurance
- Short- and Long-Term Disability Insurance
- Flexible Spending Accounts
- Health Savings Account
- Employee Assistance Programs
- Pet Insurance
- Retirement Savings 401k with company match and annual discretionary stock options
- Generous Paid Time Off, Sick Time, & Paid Holidays
- Career Development and Training
Company Overview