Medical Director / Senior Medical Director - Neurology

A day in the Life:

General Support:

• Ensures tasks delegated to medical monitors are properly executed.
• Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues.
• Adheres to client SOPs/directives and project specific WPDs for assigned projects.
• Adheres to PPD’s corporate policies and SOPs/WPDs.
• Provides medical consultation to team members and answer all study related medical questions.
• Communicates clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.
• Provides therapeutic training and protocol training on assigned studies, as requested.
• Assists in writing (interpretation of safety and efficacy data) and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the medical content is accurate and complete.

Clinical Trial Support:

• Monitors all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) of clinical studies.
• Discusses all medical concerns with principal investigators and clients (e.g. discussion regarding interpretation of inclusion/exclusion criteria) raised during the course of a study, using proper medical judgment in the interpretation and decision making with regard to clinical situations as they relate to the investigational study.
• Provides medical review of adverse events of special interest, serious adverse events and clinical outcomes events reported by study sites.
• Performs data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess for potential safety concerns.

Keys to Success:

Education and Experience:

• MD or equivalent required.
• Active medical licensure preferred but not required.
• Candidates should have clinical experience in Neurology and formal training in Neurology (i.e residency and/or fellowship), along with patient treatment experience (comparable to 2 years).
• Neuromuscular experience and/or specialization is preferred but not required.
• For Senior Medical Director Level: MD or equivalent required. Active medical licensure preferred but not required. Candidates should have a combination of clinical experience and industry experience as follows: Candidates should have clinical experience in Neurology and formal training in Neurology (i.e residency and/or fellowship), along with patient treatment experience (comparable to 2 years) and one of the following: Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry; Or Direct experience in safety/Pharmacovigilance (comparable to 2 years).
• Preference towards individuals with clinical development/medical monitoring experience.
• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
• Job leveling at Medical Director or Senior Medical Director will be determined during the consideration process, inclusive of education, experience, therapeutic area(s), and interview results.

Knowledge, Skills and Abilities:

• Therapeutic expertise in Neurology
• Strong decision-making, problem solving, organizational skills and analytical skills
• Excellent oral and written communication skills
• Working knowledge of relevant safety databases (e.g. Medra)
• Flexibility to travel domestically and internationally
• Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information
• Proficiency in basic computer applications
• Fluent in spoken and written English
• Excellent interpersonal, influencing and team building skills
• Understanding guidelines (FDA, ICH, EMA and GCP)
• Working knowledge of biostatistics, data management, and clinical operations procedures
• Ability to act as a mentor/trainer to other staff