Director, Clinical Development

Tonix Pharmaceuticals•Frederick, MD

10h•$190,000 - $240,000

About The Position

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. The 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 and provides medical guidance to investigators, clinical sites, CROs, and internal study teams. In collaboration with Clinical Operations, Pharmacovigilance, Biostatistics, Data Management, Regulatory Affairs, and other partners, this person contributes to clinical development strategy while remaining directly involved in study execution, safety oversight, and review of emerging clinical data. Tonix Pharmaceuticals is a commercial-stage biotechnology company focused on CNS and immunology treatments. Its development programs include candidates in areas such as major depressive disorder, acute stress disorder, Lyme disease prevention, kidney transplant rejection prevention, and Prader-Willi syndrome. The company notes that investigational candidates have not been approved and their safety and efficacy have not been established.

Requirements

MD, DO, or equivalent medical degree.
At least 7 years of relevant clinical development and/or medical monitoring experience in the pharmaceutical, biotechnology, or clinical research industry.
Direct, hands-on experience serving as a Medical Monitor for industry-sponsored clinical trials.
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.
Experience reviewing and assessing adverse events, serious adverse events, 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 during study conduct.
Strong clinical judgment, including the ability to 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.
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 needs in a fast-paced biopharmaceutical environment.

Nice To Haves

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.

Responsibilities

Provide medical and scientific leadership in planning, designing, and executing Phase 1 through Phase 3 clinical development programs.
Contribute to clinical development strategies, study design, and future program planning.
Provide medical and scientific input on trial protocols, eligibility criteria, endpoints, study assessments, and measures supporting patient safety and scientific integrity.
Collaborate with Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, Pharmacovigilance, Nonclinical, CMC, Commercial, and other cross-functional teams.
Review and interpret trial results to support development decisions, regulatory strategies, and future studies.
Serve as the primary Medical Monitor for assigned trials and provide direct medical oversight throughout study conduct.
Provide medical guidance to investigators, study sites, CROs, and internal teams on patient eligibility, dosing, protocol requirements, safety events, and other medical questions.
Review and assess adverse events and serious adverse events, including causality, severity, expectedness, clinical significance, and patient-safety impact.
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 monitoring activities are 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 matters 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.
Author, review, and provide medical and scientific input into 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 preparing and presenting clinical data and responding 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.
Partner with Clinical Operations and other functional teams to resolve medical and operational issues and support high-quality trial execution.
Build and maintain 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.