Medical Director - Neurology at IQVIA

About the role:

• Join our team as the Director of Neurology and play a critical role in shaping the future of healthcare. You will have the opportunity to provide expert medical, clinical, and scientific advice to a variety of Iqvia divisions, actively participate in ground-breaking medical science trials, and serve as a trusted medical expert throughout project delivery. Your therapeutic and medical knowledge will also contribute to the success of our business development efforts. In this role, you'll have a diverse range of responsibilities, including medical monitoring and strategic inputs, with a focus that can evolve as the needs of the company change. This is a unique opportunity to make a real impact and advance your career.

Medical Monitoring:

• Primarily serves as Global Medical Advisor on assigned projects.
• Serves as Scientific Advisor and provides guidance to Project Leaders on the medical and scientific aspects of assigned projects.
• Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
• Performs medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs).
• Provides therapeutic area/indication training for the project clinical team.
• Attends and presents at Investigator Meetings.
• Performs review and clarification of trial-related Adverse Events (AEs).
• May perform medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narrative, in collaboration with the Pharmacovigilance department.
• May provide medical support for the Analysis of Similar Events (AOSE), in collaboration with or on behalf of Pharmacovigilance department.
• May perform medical review of adverse event coding.
• Performs review of the Clinical Study Report (CSR) and patient narratives.
• Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
• Available 24 hours per day, 7 days per week to respond to urgent protocol-related issues at the investigative sites.

Medical Strategy:

• Provides expert advice to the development of medically sound delivery strategies for small to large and/or complex multi-region studies in partnership with sales and other functions responsible for business development activities.
• Responsible for the development of the medically related aspects of client proposals including the budget related to medical monitoring.
• Provides medical and scientific advice to key internal stakeholders developing proposals: this may include, but is not limited to, reviewing the protocol for scientific/regulatory soundness and feasibility, identification of target site and principal investigator profiles, anticipated patient recruitment, standard of care and competitive landscape.
• Attends and presents at bid defense meeting, as required.
• Participates in strategic business development activities including presentations to prospective clients.
• Maintains awareness of industry development and may author related publications.
• May serve as Regional/Multiregional/Global Therapeutic Lead for specific indication(s).

Required Knowledge, Skills, And Abilities

• Robust and current knowledge of scientific, clinical, regulatory, commercial, and competitive landscape in the applicable therapeutic area of Neurology.
• Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research.
• Strong communication, presentation, and interpersonal skills, including good command of English language (both written and spoken).
• Ability to establish and maintain effective working relationships with co-workers, managers, and clients.
• Proven skills in providing consultation and advice on multiple assignments are required, as well as initiative and flexibility.

Essential Required Education And Experience

• You must have a Medical Degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education.
• It is essential you have completed Board certification / clinical residency in Neurology.
• You have completed a minimum of 5 years clinical neurology and an additional 4 years or more Clinical Trials experience within a Pharmaceutical or CRO organization