The Medical Advisor Clinical Trials (MACT) is a field-based scientific resource that strategically supports the development, medical, and scientific objectives of Alexion’s products in the different phases of development.
The MACT will work very closely with Clinical Operations & Clinical Development to ensure successful performance of clinical trials. He/She will also act as a peer scientific expert who communicates accurate and applicable scientific and medical information to Principal Investigators and Key Opinion Leaders (KOLs) and collects relevant data for Alexion from the field within a geographic area. In addition, the MACT will manage and maintain collegial and professional relationships with HCPs and identifies and facilitates collaboration opportunities with Alexion in new fields of engagement.
As International Medical Affairs team member he/she will maintain a very close collaboration with the Country Medical Affairs teams and especially with the New Product Medical Leads (Advisors). This includes regular bi-directional updates and alignment on a medical affairs plan for each individual study.
The MACT will report directly to the International Lead for Medical Affairs Clinical Trials & Launch Excellence and in dotted line to the Country Medical Director(s).The accountability for the Medical Affairs aspects of the studies will be determined for each individual study and country.
Principal Responsibilities Clinical Trial Support In close partnership with the local Medical Affairs team drive identification of potential sites and investigators for clinical trialsLiaise with Clinical Operations to support clinical study feasibility, effective study implementation, and study management based on a trial/site specific action planEnhance clinical operations efforts to improve recruitment & retention by possible education, training, clinical discussions with site’s team, e.g. on in- and exclusion criteriaEnsure appropriate conversion of trial patients after trial in accordance with country specific optionsEnsure appropriate and compliant level of PAO group involvement with Patient Advocacy teamImprove clinical trial protocols by coordinating country input, e.g. through GPT (if required) Medical Intelligence Develop in depth knowledge of the assigned therapeutic areas, in terms of sites, physicians, laboratories, networks, and current diagnostic and clinical practicesObtain valuable feedback from the field to be shared with internal stakeholders KOL Development When applicable initiate the work of identifying national or local opinion leaders, in close collaboration with the local medical affairs team. Build and maintain strong partnerships with Investigators and other external stakeholders, including professional organizations for trial related activities Scientific Communication Develop and maintain the highest scientific and medical expertise in the relevant fields and be acknowledged internally and externally as an expert & resource in the assigned therapeutic areaIdentify and address relevant educational gaps and relay those to Global and Country Medical AffairsEnsure timely and informative scientific/medical exchanges with customers and internal partners, in accordance with compliance policies and with legal requirements Medical Information Forward medical information inquiries to Global Medical Information, according to Alexion policy Compliance Stay current of local laws and guidelines, codes of practices and Alexion policies relevant to Clinical Development and Medical Affairs activity Strong collaboration with (but not limited to) Country Medical Affairs teams includind the New Product Medical Leads (Advisors)Clinical Operations & Country OperationsClinical DevelopmentLaunch excellence
Qualifications/ Experience MD, PharmD, or PhD in natural sciences Minimum 5 years of combined experience in Medical Affairs/Clinical Operations/Clinical Development Knowledge of the country’s healthcare system and market access environment Previous experience in rare diseases is of advantage Proven capacity to Communicate clearly complex scientific data, in different settings (F2F and public presentations) and to different audiences (incl. top experts in the relevant fields)Establish and develop internal and external networksPlan and manage complex projectsWork independently and proactivelyAct as a team player in multi-disciplinary settingsPositive attitude during challenging situationsWillingness to travel (up to 80 % of time)Fluency in English and relevant local languages, written and spoken
Competencies Integrity and trust Accountability Customer focus Plans and aligns Collaboration Communication and presentation skills
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