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 cuttingedge neuro technology particularly neurostimulation neuromodulation neurosurgical or similar technologies to design and oversee clinical data collection activities and ensure all clinical trial deliverables meet IQVIAs and MCRAs 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 uptodate practices and ensure consistent application of IQVIA processes and technology tools.
• Direct the development and communication of departmental systems SOPs policies and procedures including IQVIArequired 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 IQVIAs HR policies and compliance standards.
• Manage direct reports in accordance with IQVIAs 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 IQVIAs 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

• Bachelors degree in life sciences healthrelated discipline or related field.
• 1012 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.
• Expertlevel 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.
• Indepth 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 problemsolving 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 multifunctional 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 decisionmaking 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

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. potential base pay range for this role when annualized is $148300.00 $275300.00. The actual base pay offered may vary based on a number of factors including jobrelated qualifications such as knowledge skills education and experience; location; and/or schedule (full or parttime). 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.