Senior Director, Clinical Affairs - Neurology

MCRA, an IQVIA business, is seeking a senior leader with deep expertise in neurology medical device clinical trials to join our CRO team. As Director/Senior Director, Clinical Affairs – Neurology, you will play a critical role in supporting the CRO leadership team with business planning and execution of CRO engagements. You will interact with companies developing cutting-edge neuro technology, particularly neurostimulation, neuromodulation, neurosurgical, or similar technologies, to design and oversee clinical data collection activities and ensure all clinical trial deliverables meet IQVIA’s and MCRA’s standards.

This position supports the therapeutic specialization of the CRO and expertise in neurology, provides oversight and management of clinical trials, and leads Clinical Affairs functions/teams in accordance with Good Clinical Practice (GCP) guidelines, Standard Operating Procedures (SOPs), IQVIA policies, and all applicable regulatory requirements.

Responsibilities and Duties

• 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.

Required Knowledge, Skills, and Experience

• 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 ap