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 Operations is responsible for overseeing all aspects of clinical operations. This includes managing and coordinating clinical programs, services, and staff to ensure the highest level of operational efficiency. The Director reports to the Sr. Director of Clinical Operations and helps to develop and implement strategies to improve clinical outcomes and streamline internal processes.
Essential Duties and Responsibilities
- Provides direction and oversight in assigned clinical programs, including determining development strategy for a product/program
- Identifies clinical program/resource gaps and implements solutions to minimize project risks
- Assists in oversight of CRO management of outsourced activities, including development of scope of services agreements, budgets, plans and detailed timelines, and ensures that performance expectations are met
- Evaluates vendors on an ongoing basis
- Ensures deliverables, timelines, and budgets for CROs and vendors are established and achieved
- Provides guidance and support to Project Managers in the management of clinical trial budgets for specified programs
- Addresses and/or escalates to senior or executive management significant trial issues
- Develops clinical operations quality systems, including standard operating procedures, document management, personnel training, and quality control processes; works with CQA as needed
- Supports senior management in forecasting and management of project/program budgets, including long range forecasting of clinical trial and FTE costs
- Ensures departmental processes are efficient and comply with updated regulatory requirements and follow current best practices
- Manages staff, provide guidance and ongoing feedback, conducts one-on-one meetings, conducts assessments/reviews annually or as needed; Discuss areas for improvement, provide constructive feedback, and if necessary, develop a performance improvement plan for underperforming employees
- Support Sr. Director of Clinical Operations with organizing departmental meetings with clinical team
- Serve as a designated support to the Sr. Director of Clinical Operations during periods of absence or increased workload
- Supports senior management with ad hoc tasks and projects, as assigned
Necessary Skills and Abilities
- Detail oriented and organized, and adept at data entry, reporting and maintaining comprehensive records
- High level of professionalism, including meeting presence & etiquette
- Strong communication skills (both verbal and written), able to communicate with executives and staff
- Ability to manage clinical staff and lead a team
- Demonstrated ability to protect and maintain confidential and personally identifiable information
- Strong knowledge of ICH GCPs
- Ability to travel up to 25%
- Advanced level proficiency in Microsoft Office products. Experience with Office 365 and SharePoint is a plus
Educational and Experience Requirements
- Bachelor’s Degree in life sciences or related field and advanced degree highly desirable
- Minimum of 7 years functional experience with managing clinical trials and programs
- Managing and leading staff
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.
