Job Title

Role - Snr Director/ Medical MonitorDuration - 6 monthsLocation - Remote, UKOverview:Serve as medical monitor for an ongoing Phase 2 pivotal trial and Phase 1 study; provide scientific, clinical support for the assigned asset, to review trial data and work with Global safety colleagues to update regulatory documents, lead and prepare DMC, collaborates with cross functional leads to ensure that all development and asset support activities are coordinated, consistent, and completed on time. As one product is near registration, it will be important for the candidate to have experience in inspection readiness and assist in this effortDuties:To provide scientific and clinical development support for products within assigned therapy area.• Monitor subject data and communicate with site study teams to obtain updates on subject status.• Address routine study questions from clinical trial sites in adherence to ICH GCP and the study protocol.• Support development and execution of medical & clinical strategy for assigned product(s).• To review trial data and work with Global Patient Safety to update regulatory documents ie investigator brochure, development safety update report.• Development and review of clinical study documents ie ICF, protocol updates, CSR.• Provide relevant clinical scientist expertise to internal teams, including clinical operations, medical writing, biostatistics, data management, and pharmacovigilance to ensure quality processes and deliverables.• Assist in the review, analysis and reporting of clinical trial data and related publications.• Assist with ongoing monitoring of safety data and regular medical review of clinical trial data.• To lead preparations for Data Monitoring Committee meetings including quarterly safety updates and appropriate slide presentations.• Serve as a scientific resource to cross-functional internal teams to facilitate quality of study execution and problem resolution.• Ensure concise written reports are provided as needed.• Collaborates with Global Asset Lead, Clinical development Lead, Clinical Operations, Global Patient Safety, Biometry & Data Management, and any other relevant function to ensure that all development and asset support activities are coordinated and consistent.• Remains up to date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities.• Provides expert scientific clinical development advice to the asset team for the development of Phase I-IV clinical programs.• Reviews clinical protocols and clinical study reports for scientific and operational accuracy.• Participates in drug safety surveillance for development projects.• Develops and demonstrates expertise in data review and interpretation to deliver meaningful efficacy and safety conclusions.• Demonstrates the ability to interpret conclusions in context of product profiles and medical practice to create key messages, in collaboration with key stakeholders.Knowledge, Abilities & Experience:• Pharm D, pharmacist, or PhD or nursing qualification is strongly preferred but not required. Equivalent combination of education and relevant experience may be considered on a case by case basis. Scientific/healthcare field experience relevant to the application. Advanced degree preferred.• Significant experience (7-10+ years) of clinical research and organizational management within the pharmaceutical industry, a CRO, academia or similar organization.• Expertise and/or experience in rare diseases highly desired• Demonstrated in-depth understanding of drug development.• Attention to detail and prompt follow up on actions.• Demonstrated ability to collaborate in a matrix environment.• Experience in assisting and providing support for regulatory submissions such as IND/CTA/NDA/MAA and• Experience in designing and conducting Phase I-III clinical trials, including importance of translation into CRFs and SAP• Experience in reviewing clinical trial data and being able to quickly assimilate to a wider audience.