About Tonix* Tonix is a biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP). The Company is focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease. Tonix markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. The Company’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, which also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. About the Role: The Director of Clinical Development will play a pivotal role in shaping the strategic direction of our clinical programs, ensuring that they align with the overall goals of the organization. This position is responsible for overseeing the design, implementation, oversight, and management of clinical trials, including regulatory interactions, with a focus on delivering high-quality data that supports regulatory submissions and product development. The Director will collaborate closely with cross-functional teams, including regulatory affairs, biostatistics, and medical affairs, to ensure that clinical development plans are executed efficiently and effectively. Additionally, this role will involve mentoring and leading a team of clinical professionals, fostering a culture of innovation and excellence. Ultimately, the Director of Clinical Development will contribute to advancing our pipeline and bringing new therapies to market that improve patient outcomes. Minimum Qualifications: MD or DO degree. A minimum of 10 years of experience in clinical development within the pharmaceutical or biotechnology industry. Proven track record of successfully leading clinical trials and managing cross-functional teams. Preferred Qualifications: Experience with regulatory submissions to agencies such as the FDA or EMA. Familiarity with therapeutic areas relevant to our pipeline, such as rheumatology and oncology, and/or development of biologics. Previous experience in a leadership role within a clinical development organization. Responsibilities: Serve as medical lead on strategic planning and execution of clinical development programs from Phase I through Phase III. Oversee the design and implementation of clinical trial protocols, ensuring compliance with regulatory requirements, GCP, and industry standards. Provide medical monitoring support, including reviewing safety data, overseeing eligibility reviews, and ensuring appropriate AE/SAE reporting. Collaborate with cross-functional teams including nonclinical, CMC, biostatistics, regulatory, safety/pharmacovigilance, and commercial. Analyze clinical data and prepare reports for regulatory submissions, ensuring accuracy and clarity in communication. Author and/or provide strategic input on clinical documents including protocols, investigator brochures, INDs, CTAs, and regulatory briefing documents. Participate in regulatory interactions (FDA, EMA, etc.), including preparation and presentation of clinical data and strategic input into regulatory submissions. Collaborate with internal and external stakeholders to align clinical development strategies with business objectives. Manage and mentor a team of clinical research professionals, providing guidance and support in their professional development. Contribute to publication strategy and represent the company at scientific and medical conferences. Skills: The required skills for this role include strong leadership and project management abilities, which are essential for guiding clinical teams and ensuring that projects stay on track. Excellent communication skills are necessary for effectively collaborating with various stakeholders and presenting complex data in an understandable manner. Analytical skills are crucial for interpreting clinical data and making informed decisions that impact the development process. Preferred skills, such as regulatory knowledge, enhance the ability to navigate the complexities of clinical trials and submissions. Overall, a combination of these skills will enable the Director to drive successful clinical development initiatives and contribute to the advancement of innovative therapies. Recruitment & Staffing Agencies Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes. Compensation & Benefits Annualized base salary ranges from $150,000 to $240,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit. Tonix provides a comprehensive compensation and benefits package which includes: Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and 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 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. In addition to federal law requirements, Tonix complies with applicable state and local laws governing nondiscrimination in employment. 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. Tonix expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic, information, disability, veteran status, or any other characteristic protected by law.