Senior Director – Clinical Affairs – Neurology

Senior Director – Clinical Affairs – Neurology

Requirements

• Bachelor’s degree in life sciences, health-related discipline, or related field.
• 10–12+ years of experience in clinical trials, including substantial project management experience and at least four years of supervisory experience.
• 5+ years of neurostimulation (BCI, DBS, etc.) or similar neurology medical device clinical trial experience required.
• Expert-level knowledge of neuro medical device trials, including lessons learned from recent trials.
• High degree of creativity in developing approaches to neuro and digital health products.
• In-depth knowledge of clinical project management, GCP, ICH guidelines, and clinical monitoring procedures.
• Demonstrated ability to manage multiple clinical studies and project deliverables simultaneously.
• Experience using Electronic Data Capture (EDC) and clinical trial management systems.
• Advanced proficiency in MS Office Suite (Outlook, Word, PowerPoint, Excel) and internet applications.
• Strong understanding of therapeutic areas for assigned clinical projects.
• Strong organizational, prioritization, and problem-solving skills, with the ability to handle multiple tasks and meet deadlines.
• Excellent oral and written communication and presentation skills.
• Proven ability to manage, coach, and develop diverse teams, set milestones, and hold individuals accountable for results.
• Ability to work across global, multi-functional teams with cultural awareness.
• Excellent customer service skills and ability to understand customer needs, negotiate solutions, and drive results to meet client and company standards.
• Strong decision-making, judgment, and risk management abilities.
• Demonstrated learning agility and openness to continuous improvement.
• Expertise in department and personnel management, including hiring, training, and performance management.

Responsibilities

• Collaborate with senior Clinical Affairs leadership and executive management to develop operating objectives, organizational structure, and staffing requirements.
• Ensure clinical trial projects are properly resourced, managed, and executed within budget and in accordance with established timelines, quality standards, IQVIA systems, and applicable regulations.
• Implement techniques to improve productivity, maintain up-to-date practices, and ensure consistent application of IQVIA processes and technology tools.
• Direct the development and communication of departmental systems, SOPs, policies, and procedures, including IQVIA-required systems and tools.
• Collaborate with Clinical Quality Assurance on CRO vendor selection, evaluation, and oversight.
• Develop and review project documents for accuracy, completeness, and compliance with company or client SOPs, GCP, and regulatory requirements.
• Lead and direct project teams to ensure project deliverables meet client timelines and quality expectations; proactively manage risks related to project scope, budget, and timelines.
• Approve reports and study communications generated by the project team for distribution to sponsors and investigators.
• Develop and maintain positive relationships with internal and external stakeholders, including clients, team members, and site personnel (PIs, study coordinators).
• Submit regular status updates to sponsors/clients and respond to questions and concerns.
• Collaborate on business development initiatives, including proposal development and bid defenses.
• Serve as a clinical project manager for client projects, as needed.
• Assist with professional development and coaching of Clinical Trial Managers, CRAs, and CTAs.
• Oversee hiring, training, and onboarding of clinical staff, ensuring alignment with IQVIA’s HR policies and compliance standards.
• Manage direct reports in accordance with IQVIA’s policies, including performance reviews, development planning, coaching, mentoring, and addressing employee relations issues.
• Ensure direct report employees are fully trained and meeting project and organizational needs, using IQVIA’s systems for performance tracking and reporting.
• Lead or actively participate in corporate initiatives, serve as a departmental liaison, and provide technical expertise and project management leadership.

Preferred Qualifications

No preferred qualifications provided.