Senior Director, Regulatory & Scientific Affairs

Job Summary: The Sr. Director of Regulatory and Scientific Affairs is responsible for providing scientific and regulatory strategy and expertise to clients, substantive input, and leadership to all phases of regulatory and scientific affairs projects in accordance with any applicable CTI Standard Operating Procedures (SOPs) and all applicable regulations.

What You’ll Do

• Lead and participate in drug development projects, including strategic development plans, Pre-Investigational New Drug (Pre-IND), IND, New Drug Application (NDA) and Biologic License Application (BLA), Investigational Device Exemption (IDE), and other regulatory documents
• Provide drug / device regulatory guidance to project teams and clients; facilitate and lead interactions with regulatory authorities (eg, Food and Drug Administration [FDA], European Medicines Agency [EMA], and Health Canada)
• Conduct scientific research and assimilate data into written deliverable products for clients, including abstracts, clinical study protocols, clinical study reports (CSRs), written summaries, training materials, and other documents intended for submission to regulatory authorities
• Provide direction to team members and oversee regulatory and scientific affairs projects
• Lead and participate in advisory boards, training programs, and review scientific writing projects, including manuscripts, monographs, briefing documents, and market analysis
• Interact professionally with clients, thought leaders, and external consultants to understand their objectives and meet their needs
• Participate in business development (BD) capabilities presentations, client visits, and programs
• Collaborate with Medical Affairs, Biostatistics, Data Management, Clinical Project Management, and other disciplines as needed to meet internal and external client objectives
• Provide project status reports to senior/executive management and project management leads
• Present information at internal and external meetings
• Maintain ongoing knowledge of updated US and Global regulatory requirements, guidance documents, and best practices
• Support senior and executive management in the enhancement of departmental performance and development of best practices
• Develop and conduct internal/external training and continuing education activities
• Develop and maintain knowledge and expertise across multiple therapeutic areas through clinical ongoing awareness of industry practices, and participate in professional development activities
• Provide input into and/or lead the development of or improvement of internal processes and operations

What You’ll Bring

• Masters of Science, Masters of Public Health, Master’s, or Doctoral degree in fields such as allied health, nursing, pharmacy or natural sciences or Bachelor’s degree with appropriate level of experience in Regulatory and Scientific Affairs
• 10 years of direct experience working in the pharmaceutical industry (eg, contract research organization or pharmaceutical company) or related area with a focus in drug development, regulatory affairs, and/or medical writing; or at least 7 years of experience with an advanced degree in a related area (MD/DO/MBBS, PharmD, DrPH, PhD, MS, Nurse Practitioner)
• Demonstrated history of direct interaction with regulatory agencies (eg, FDA, EMA, Health Canada)
• Extensive experience in preparing technically complex documents intended for submission to regulatory authorities (eg, briefing documents, CSRs)
• Experience leading project teams and working effectively across multi-functional teams
• Industry and/or clinical experience with orphan and rare disease designations, hematology/oncology, immunology, and other complex medical disease states preferred

About CTI

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com