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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 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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

The potential base pay range for this role, when annualized, is $148,300.00 - $275,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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