Director, Clinical Regulatory and Compliance

Job Summary: Oversees clinical research, regulatory compliance, and research document management including the establishment of appropriate policies and standard operating procedures. Oversees internal and external quality assurance/audits of clinical trials and supporting functions. Manages National Institutes of Health (NIH) research financial conflicts of interest process and catalogue of the organization's human subject research projects. Selects, develops, evaluates, and manages staff of Regulatory Affairs/ Quality Assurance/Records Management division. Accountabilities: Directs and develops programs and processes to meet management objectives and compliance with government agencies. Oversees coordination and preparation of regulatory submissions to government agencies. Serves as the liaison to the Food & Drug Administration (FDA) and other regulatory agencies on matters related to one or more studies. Develops and manages budget for organizational unit and reports status to management. Advises/coaches staff to ensure compliance with internal and external policies, laws, and regulations. Participates in the strategic development of methods, techniques, studies, and people. Contributes to computer system validation efforts for all electronic clinical research systems. Supports performance management and professional development of direct reports, including ongoing feedback, coaching, and career support. Performs other duties assigned. Applied Knowledge & Skills: Comprehensive knowledge of theories, concepts and practices with regulatory agencies and compliance management. Excellent and demonstrated project management skills. Excellent oral and written communication skills. Strong critical thinking and problem-solving skills to plan, organize, and manage resources for successful completion of studies/project goals. Ability to motivate, influence, and collaborate with others. Articulate, professional and able to communicate in a clear, positive manner with clients and staff. Demonstrated commitment to diversity, equity, and inclusion. Must be able to read, write and speak fluent English. Problem Solving & Impact: Decisions and actions have a significant impact on management and division operations. Problems encountered are complex, highly varied and require considerable judgment. Excellent strategic and operational decision maker that interprets business strategies and develops objectives to align with organization goals. Supervision Given/Received: Sets goals and budgets for department and leads studies or projects that have significant financial implications. Leads coordination of resources for ongoing projects across business groups and addresses/resolves issues. Typically reports to the EVP & General Counsel. Education: Bachelor's Degree or its International Equivalent in Life Sciences, Communications, Journalism, Public Health or Related Field. Experience: Typically requires a minimum of 10+ years of regulatory affairs and compliance management experience (including a minimum 5+ years of experience in a senior management/leadership position). Prior experience with managing a staff and interacting with the FDA and international regulatory agencies. Typical Physical Demands: Typical office environment. Ability to spend long hours looking at computer screen and doing repetitive work on a keyboard. Ability to sit and stand for extended periods of time. Ability to lift/move up to 5 lbs. Technology to be Used: Personal Computer/Laptop, Microsoft applications (i.e., Office 365, SharePoint, Skype/Zoom/Teams), cell phone/mobile technology, and standard office equipment. Travel Requirements: 10% - 25% US Based Hiring Salary Range:

$130,000 - $180,000 International hiring ranges will differ based on location. This job posting summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time. FHI 360 is an equal opportunity and affirmative action employer

whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law. FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support a healthy work/life balance. Join our global workforce to make a positive difference for others - and yourself.

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