Position Overview

The Director, Clinical Development provides medical and scientific leadership across clinical development programs, supporting the design, execution, and oversight of clinical trials from Phase 1 through Phase 3. This role combines strategic clinical development responsibilities with hands-on medical monitoring to ensure patient safety, scientific integrity, regulatory compliance, and high-quality clinical data.

The Director serves as the primary Medical Monitor for assigned studies, providing timely medical guidance to investigators, clinical sites, CROs, and internal study teams. Working closely with Clinical Operations, Pharmacovigilance, Biostatistics, Data Management, Regulatory Affairs, and other cross-functional partners, this individual contributes to clinical development strategy while maintaining direct involvement in study execution, safety oversight, and emerging clinical data.

Guided by Tonix's core values of integrity, commitment, innovation, and passion, the Director applies sound clinical judgment, scientific expertise, and collaborative leadership to advance development programs and support the delivery of innovative therapies to patients.

Key Responsibilities

Clinical Development and Study Strategy

• Provide medical and scientific leadership in the strategic planning, design, and execution of clinical development programs from Phase 1 through Phase 3.
• Contribute to clinical development strategies, study design, and future clinical program planning to support organizational objectives.
• Provide medical and scientific input into clinical trial protocols, eligibility criteria, endpoints, study assessments, and other measures supporting patient safety and scientific integrity.
• Collaborate with cross-functional teams, including Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, Pharmacovigilance, Nonclinical, CMC, and Commercial, to align clinical development activities with program objectives.
• Review and interpret clinical trial results to support development decisions, regulatory strategies, and future studies.

Medical Monitoring and Patient Safety

• Serve as the primary Medical Monitor for assigned clinical trials, providing direct medical oversight throughout study conduct.
• Provide timely medical guidance to investigators, study sites, CROs, and internal teams regarding patient eligibility, dosing, protocol requirements, safety events, and other study-related medical questions.
• Review and assess adverse events (AEs) and serious adverse events (SAEs), including causality, severity, expectedness, clinical significance, and potential impact on patient safety.
• Review patient-level and aggregate clinical and safety data, including laboratory results, eligibility assessments, protocol deviations, and emerging safety trends.
• Develop, review, and maintain study-specific Medical Monitoring Plans and ensure medical monitoring activities are appropriately documented.
• Collaborate with Pharmacovigilance to evaluate potential safety signals and determine appropriate follow-up, escalation, or additional surveillance.
• Review clinical data listings to identify medical inconsistencies, emerging trends, and issues requiring further investigation.
• Support Data Monitoring Committees and Data Safety Monitoring Boards, as applicable.
• Provide clinical training and ongoing medical guidance to investigators, study teams, and site personnel.

Regulatory and Scientific Activities

• Author, review, and provide medical and scientific input into clinical and regulatory documents, including protocols, investigator brochures, informed consent materials, clinical study reports, INDs, CTAs, and regulatory briefing documents.
• Participate in regulatory interactions with the FDA, EMA, and other global health authorities, including preparation and presentation of clinical data and responses to regulatory questions.
• Collaborate with internal and external stakeholders to address clinical and regulatory issues and support development milestones.
• Contribute to scientific publications, presentations, and medical or scientific congress activities, as appropriate.

Cross-Functional Collaboration and Leadership

• Partner with Clinical Operations and other functional teams to resolve medical and operational issues and support high-quality clinical trial execution.
• Build and maintain effective relationships with investigators, key opinion leaders, external medical experts, CROs, and clinical development partners.
• Provide medical and scientific guidance to clinical research professionals and cross-functional study teams.
• Mentor and support the professional development of clinical team members, as applicable.
• Promote collaboration, accountability, and continuous improvement across clinical development activities.

Qualifications

• MD, DO, or equivalent medical degree required.
• Minimum of 7 years of relevant clinical development and/or medical monitoring experience within the pharmaceutical, biotechnology, or clinical research industry.
• Direct, hands-on experience serving as a Medical Monitor for industry-sponsored clinical trials required.
• Demonstrated ability to independently make medical decisions and serve as the primary Medical Monitor for assigned studies.
• Experience supporting Phase 1 through Phase 3 clinical trials.
• Experience with clinical trial design, protocol development, clinical data review and interpretation, and clinical study documentation.
• Strong knowledge of Good Clinical Practice (GCP), clinical trial safety reporting requirements, applicable regulatory guidelines, and clinical documentation standards.
• Clinical and Medical Expertise
• Strong experience reviewing and assessing AEs, SAEs, clinical laboratory data, patient eligibility, protocol deviations, and emerging clinical and safety information.
• Experience responding directly to investigator and site medical questions and providing timely medical guidance throughout study conduct.
• Excellent clinical judgment with the ability to independently evaluate complex medical information, recognize potential safety signals, and determine appropriate escalation or follow-up.
• Ability to interpret clinical and safety data and translate findings into actionable medical and scientific recommendations.
• Leadership and Communication
• Proven ability to collaborate effectively with multidisciplinary teams and provide medical leadership across clinical development activities.
• Strong analytical, organizational, communication, and problem-solving skills.
• Ability to communicate complex medical and scientific information clearly to investigators, study teams, regulatory authorities, and other stakeholders.
• Ability to work independently, manage competing priorities, and adapt to evolving clinical development needs in a fast-paced biopharmaceutical environment.
• Preferred Qualifications
• Experience supporting later-stage clinical development programs.
• Experience with regulatory submissions and interactions involving the FDA, EMA, or other global health authorities.
• Therapeutic area experience relevant to Tonix's development programs, including rheumatology, oncology, infectious disease, vaccines, and/or biologics.
• Previous experience providing clinical development leadership and mentoring clinical research professionals.
• Experience contributing to scientific publications, presentations, or regulatory development strategies.