Senior Director Medical Affairs

Senior Director Medical Affairs

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.

Position Overview

The Senior Director of Medical Affairs Operations plays a pivotal role in leading and optimizing the operational functions within the Medical Affairs department to ensure alignment with organizational goals and regulatory standards. This position is responsible for shaping processes, driving efficiency, and ensuring excellence across Medical Affairs initiatives, including cross-functional collaboration with clinical, regulatory, and commercial teams. The Senior Director will also lead a team of professionals, fostering a culture of excellence, innovation, and accountability to support the delivery of high-impact medical strategies. This role will partner with senior leadership and cross-functional stakeholders to enable impactful scientific engagement, compliant execution, and operational innovation.

Essential Duties

• Lead and manage the operational activities of the Medical Affairs department, ensuring alignment with corporate objectives and compliance with industry regulations.
• Lead planning, budgeting, and resource allocation to deliver on key Medical Affairs initiatives.
• Oversee implementation and optimization of tools that support medical information, publications, and scientific exchange.
• Develop and implement strategic plans to enhance the efficiency and effectiveness of medical affairs processes.
• Lead investigator-initiated research and educational grant programs.
• Collaborate cross-functionally with clinical development, regulatory affairs, commercial, compliance, and external stakeholders to support integrated medical strategies.
• Ensure processes and systems meet global regulatory and compliance standards.
• Oversee budgeting, resource allocation, and performance metrics to optimize departmental productivity and impact.
• Mentor and develop a high-performing team, promoting professional growth, accountability, and adherence to ethical standards.
• Assist in the dissemination of clinical data and scientific messaging, collaborating with clinical, marketing, market access, and commercial teams.
• Attend and support key regional and national scientific and medical meetings, including team preparation, staffing medical booths, and creating post-meeting summaries as necessary.
• Contribute to the development and execution of the overall Medical Affairs strategy by providing insights on operational capabilities, resource allocation, and operational efficiency.
• Develop key performance indicators (KPIs) to track operational performance and provide regular reports to senior leadership on progress, challenges, and areas for improvement.

Educational and Experience Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or a related field; advanced degree (PhD, PharmD, MD, or equivalent) preferred.
• Minimum of 10 years of experience in Medical Affairs or related pharmaceutical/biotechnology industry roles, with at least 5 years in a leadership capacity with direct people management responsibilities.
• Demonstrated expertise in medical operations, including medical communications and compliance with regulatory requirements.
• Proven ability to lead cross-functional teams and manage complex projects in a fast-paced environment.
• Strong understanding of industry regulations, guidelines, and best practices relevant to Medical Affairs.
• Excellent communication, leadership, and problem-solving skills.

Preferred Qualifications

• Advanced certifications or training in project management, leadership, or regulatory affairs.
• Familiarity with digital tools and platforms used in Medical Affairs operations, such as CRM systems.
• Experience in budget management and strategic resource planning.
• Experience with medical systems/CRM platforms preferred.

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 $200,000 to $300,000 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.