Tonix Pharmaceuticals
VP, Clinical Development - Infectious Disease
Frederick, Maryland or Berkeley Heights, New Jersey · Vp
No sponsorship$250k-$350kDetected 85 days ago
GCPStatisticsComplianceBusiness DevelopmentNegotiationRecruitingIntellectual PropertyClinical TrialsClinical ResearchFDA RegulatoryPharmacovigilanceResearchLeadershipCommunicationMentoringPublic SpeakingRegulatory Affairs
About the role
- Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need.
- TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8 mg) is the first new treatment for fibromyalgia in adults in more than 15 years.
- Tonix is investigating TONMYA® in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction.
Responsibilities
- 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.
- 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.
Requirements
- Expertise and experience in infectious diseases.
- Experience in comprehensive budget management.
Nice to have
- Board certification in Infectious Disease a plus
- Prior work with Lyme disease, live viral vaccines and or prophylactic monoclonal antibodies a major plus.
Skills
- Demonstrated success in leading clinical development programs.
Compensation
- $250,000 - $350,000 USD
- Compensation & Benefits
- Tonix provides a comprehensive compensation and benefits package which includes:
- Retirement Savings 401k with company match and annual discretionary stock options
- This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training.
Benefits
- 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.
Equal opportunity
- Tonix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, or any other characteristic protected by law.
Visa & Work Authorization
- Please note that Tonix does not offer sponsorship for this role.
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This listing is sourced directly from Tonix Pharmaceuticals's careers page and normalized into a canonical job model.