Tonix Pharmaceuticals · 6 days ago
VP, Clinical Development - Infectious Disease
Berkeley Heights, NJ
Full-time
Onsite
Director/Executive
$250K/yr - $350K/yr
10+ years expTonix Pharmaceuticals is a fully integrated biotechnology company focused on commercializing and developing therapeutics for human diseases. The Vice President of Clinical Development for Infectious Disease will oversee the clinical development strategy, ensuring compliance with regulatory standards and leading clinical trials from planning to execution.
BiopharmaBiotechnologyMedicalPharmaceutical
Responsibilities
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
Qualification
Required
MD or DO required
Board Certification in Internal Medicine and Infectious Diseases
Demonstrated success in leading clinical development programs
Extensive experience with regulatory interactions, submissions, and product approvals
Experience in comprehensive budget management
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
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
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
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
Tonix Pharmaceuticals
Tonix is a biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$336.74MKey Investors
Point72Medical CBRN Defense ConsortiumTechnology Partners
2025-12-29Post Ipo Equity· $20M
2025-03-10Grant
2024-06-12Post Ipo Equity· $4M
Leadership Team
Seth Lederman
CEO
Zeil Rosenberg
Executive Vice President, Medical
Recent News
2025-12-29
2025-12-29
Company data provided by crunchbase