(Associate) Medical Director - Epileptology, EMEA (Client-dedicated) at Thermo Fisher Scientific

• The Medical Director will provide medical support and medical advice for clinical trials and safety evaluation within the PPD Pharmacovigilance department.

A day in the Life:

• Provide medical leadership to the study teams, including creating clinical trial protocols while implementing the latest scientific information, contribute to site selection, involved in review and approval of study protocols and amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), protocol deviation decisions and other clinical documents as required for the conduct of clinical trials
• Real time Medical Monitoring of clinical studies: ensure medical validity of each individual primary endpoint as well study subject safety, while ensuring medical issues are identified early. Pro-active customer concern and correction of issues in consultation with the Global Medical Indication Lead
• During initial review of protocol, consults with internal groups and support staff regarding procedural and budgetary items and the necessity for change due to any subsequent protocol amendments. Acquires other functions’ dedication to close gaps and address issues timely and effectively. Serves as chief liaison between sponsor and all PPD internal departments performing the required tasks during all study phases. Educates Investigator sites by delivering a protocol specific lab procedures presentation and demonstration during an investigator meeting. Controls, handles and follows day to day activities during the course of the clinical trial to resolve any issues and answer queries
• Medical point of contact for all internal and external stakeholders: Interact with the investigators as needed, answer questions of IRBs and Health Authorities, prepare and present material to the study executive and independent safety committee if applicable; medical training of site staff at Investigator meetings; CRA training in new indications
• Ensure study compliance for all medical aspects by understanding and applying all relevant SOPs and GCP
• Closely collaborate with the cross functional study team members in order for medical risks, issues, and results to be clear to all involved parties

Education

• Medical Doctor, with a specialty in Neurology with focus in Epilepsy, shown clinical experience running patients with Epilepsy in hospital practice

Knowledge, Skills, Abilities

• Significant experience within pharmaceutical industry, clinical trials and pharmaceutical medicine is critically important
• Solid experience with PIPs (pediatric investigation plan)
• Is fluent in spoken and written English
• Shown understanding and experience with NDA submission process.
• Shown understanding of regulatory guidelines for adverse event reporting
• Strong communication & presentation skills and is a strong teammate