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Director, Medical Affairs This is what you will do: Director, Medical Affairs will provide strategic planning and leadership to all incountry Medical Affairs activities and will manage the performance and development of the local Medical team. Director, Medical Affairs will provide scientific and medical leadership that advances the understanding of the medical landscape in relation to relevant diseases and Alexion products, and support the development and implementation of appropriate strategies within the country in line with the Global Medical Affairs Plan. He/she will provide medical leadership and support crossfunctional teams.He/she will guide the local country Medical Affairs team to ensure achievement of local and regional objectives as well as the Alexion Global Medical Affairs mission to maximize patient outcomes by setting and continuously advancing the evidencebased medical standard of care. You will be responsible for: Build and continuously develop an country medical team in a highly, matrix environment that: Develops and continuously maintains the highest scientific and medical expertise with all relevant diseases and products and is acknowledged both internally and externally as such Develops and executes a country Medical Plan and strategy, to support best clinical practice, in line with Global Alexion objectives (including global Medical Affairs and Commercial) through actively engaging cross functionally with appropriate stakeholders, local market intelligence and development opportunities Develops external relationships with relevant medical groups (e.g.research centers, hospitals, professional associations) in support of Alexion objectives Leads all activities in accordance with the latest, relevant current local and regional pharmaceutical regulations and Alexion policies and procedures Demonstrate the appropriate leadership, direction and accountability for: Leading and managing direct reports to ensure achievement of objectives, personal development, and ensuring the team is trained and equipped to achieve established goals Ensuring fieldbased medical teams have clear objectives, performance metrics and agreed working relationships with other functions Creating development opportunities for team members through implementation of development plans, training opportunities and relevant opportunities Routinely assessing, maximizing and communicating the performance of the medical affairs team Defining the country Medical resource needs and leading the Medical budget planning, resource allocation and budget management Organizing the country medical information function, ensure timely response to medical information inquiries and collation of requests, utilizing global medical information resources and in line with local regulatory requirements and company policy Ensuring effective team communication, performance and documentation of medical affairs activities and knowledge through the application of suitable reporting systems and structures Identifying training needs with other functional leaders and ensure implementation of training programs for the commercial teams and other functions, providing medical leadership and education in line with local and global strategy and preparing staff to handle interactions with customers Collaborating with Clinical Operations to manage the in country Clinical Operations Lead role and ensuring their activities are prioritized to meet the clinical operations and country objectives Ensuring the country Medical team in all existing and potential new therapeutic areas are appropriately resourced, directed and integrated with other functions to: Drive the identification and development of Key Opinion Leaders, other important customers and stakeholders, including professional organizations. Provide medical leadership, insight and strategy to all Alexion activities, collaborating across functions, including ensuring the highest level of medical education for all Alexion employees to maximize patient outcomes Identify and implement appropriate highimpact medical research projects to support the business objectives, including Alexionsponsored and investigator initiated projects Manage requests for Alexion product supply in compassionate use cases, in accordance with local regulations and Alexion policy Provide medical input to the development of impactful scientific and medical education messages and materials Review and approve promotional materials to ensure information is accurate, relevant to the Country environment, and ensure medical accuracy Support reimbursement applications locally or nationally, ensuring knowledge of processes, development of appropriate medical materials and supportive documents and provision of medical expertise as required Lead the implementation of medical practices to assess new indications, the treating community, patient pathways, identifying patients for clinical research and to develop a thorough understanding of the disease area Initiate and support high impact medical education activities, such as advisory boards, congress symposia, hospital meetings and speaker development programs Perform clinical study feasibility and support effective study implementation and ongoing management of Alexion sponsored trials, including disease Registries, to achieve recruitment and objectives, in conjunction with Regional clinical operations Support crossfunctional teams to ensure patientfocused activities at all times, including timely responses to specific internal and external requests to discuss specific situations and challenges and provide medical affairs support to all stakeholders. Provide appropriate and timely medical support, including time spent in the field, to all commercial team efforts, in particular to patient identification, increasing the urgency to treat, access to funding and appropriate product utilization, with the ultimate goal of maximizing patient outcomes. Attend appropriate national and international meetings and congresses to gather intelligence, assist personal education, ensuring to utilize these opportunities to develop relationships with important customers Responsible for reporting all pharmacovigilance events, product quality complaints and medical information requests within 24 hours as of awareness according to the local applicable procedures.
Organizing the patient education programs for all required indications under and/or within risk management plan. Budget management for PEP in third parties. Ensure all 3.parties selected by Medical Affairs are following the quality and regulatory requirements and company policy in terms of, compliance, code of ethics, data privacy law and pharmacovigilance. The main responsibility belongs to medical director and in case of absence to the related delegate (MAM, MA).
You will need to have: Medical degree (M.D.), experience in clinical practice and minimum of 10 years in the Pharmaceutical or biotech industry. Minimum of 7+ years in medical affairs and leadership roles Experience in leading teams and managing people in a complex, matrix environment Product lifecycle management experience preferred Demonstrated success in managing Medical Affairs teams, across therapeutic areas with a comprehensive understanding of the compliance issues concerning Medical Affairs Orphan diseases knowledge/experience, preferred Demonstrated ability to create and manage successful crossfunctional teams in changing, competitive environments Demonstrated ability to influence important customers, challenge common perceptions and implement medical affairs tools to improve patient care and outcomes Good analytical skills as applied to medical, scientific and technical information. emonstrated ability to accurately and effectively evaluate medical/scientific literature and develop effective medical strategies and communication strategies. Demonstrated experience in early and late clinical development.
Excellent written and verbal communication skills in both local language and in English Computer skills Adaptability to multicultural environment The duties of this role are generally conducted in an office environment. As is typical of an officebased role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and nonlinear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
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