Job Description
<b>Job Description Summary</b>Accountable for all country clinical/medical aspects associated with Development and prioritized Re- search programs/trials by providing clinical strategic and tactical leadership as the Country Clinical Development representative. May work across several countries.<br>Gathers, informs, and acts on <span>clinical/medical/scientific</span> insights for clinical trial concept sheets/protocols, Informed Consent Forms (ICFs) and other relevant clinical documents to optimize clinical trial implementation.<br>Drives the identification and involvement of qualified investigators with greatest recruitment potential, identifies clinical recruitment hurdles and drives clinical recruitment activities to overcome these hurdles.<br>Accountable for adherence to safety standards and clinical data quality in the country by providing general clinical/medical support for trial related safety findings.<br>*In close collaboration with other country functions (e.g., clinical trial operations, Medical Affairs and Patient Engagement) actively contributes to successful allocation, fast clinical trial start-up, timely recruitment, early identification of potential delays, and development and implementation of mitigation plans.<br> <b>Job Description</b><b>Major Accountabilities</b><ul><li>Provides Clinical Development and indication expertise specific to Country, and together with the clinical trial operations team, drives the execution of clinical trials with high quality and within planned time- <span>lines:</span></li><li>Validates study designs, is accountable for, and makes the final decision on the clinical/medical trial and program feasibility of implementing a clinical trial protocol based on medical/clinical practice and analysis of the competitive environment in the country.</li><li>Actively contributes to <span>scientific/clinical/medical</span> aspects of the start-up phase to ensure fast clinical trial site start-up.</li><li>Provides clinical/medical expertise to clinical trial operations team members and clinical trial sites for Institutional Review Boards (IRB)/ Ethics Committee (EC) interactions.</li><li>Decides on <span>site/Country-specific</span> <span>scientific/clinical/medical</span> content of the Informed Consent Form (ICF) as needed and ensures appropriateness of patient suitable language.</li><li><span>Provides</span> <span><span>scientific/clinical/medical</span></span> <span>expertise</span> <span>during</span> <span>interactions</span> <span>with</span> <span>Country</span> <span>external</span> <span>Experts </span>(e.g., Regulatory Authorities, Medical Experts, Advisory Boards, Patient Advocacy Groups, etc.).</li><li>Develops clinical/medical trial plans taking the broader ecosystem into account for assigned pro- grams/trials to ensure successful trial implementation, which includes:<ul><li>Pro-actively identifying early on clinical challenges to recruitment or clinical data quality and drives development of clinical/medical mitigation plans.</li><li>Building disease area expertise, especially for new/rare <span>indications.</span></li></ul></li><li>Provides robust indication, compound, and protocol <span>training:</span><ul><li><span>To</span> <span>the</span> <span>clinical</span> <span>operations</span> <span>team</span> <span>in</span> <span>the</span> <span>country,</span> <span>especially</span> <span>to</span> <span>the</span> <span>Clinical</span> <span>Research</span> <span>Associates, </span>and other country line functions as needed.</li><li>Externally as needed in the Country at Investigator's Meetings or scientific venues to support recruitment and trial awareness.</li></ul></li><li>Leverages innovation in clinical trial planning and decides on clinical/medical recruitment strategy and implementation based upon physician interviews, analysis of competitive trials