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Senior Director, Medical Affairs- International

Description

Senior Director, Medical Affairs- International Paddington, United Kingdom The Senior Medical Director (SMD) Haematology will provide medical leadership for the International Medical Department in all Haematology. This is a crucial role and will be effectively a “Player- manager role”. The focus of the Medical Affairs team will be external stakeholder engagement, and as such it is desired that the incumbent in this role will do this job as well as leading and managing medical affairs colleagues based in countries and the scientific advisor in IHQ. As such, the SMD will be accountable for building, leading and overseeing the country Haem medical teams, for the development and implementation of Country Medical Haem strategy and plans and will work in partnership with the Regional Medical leads as well as other cross functional team colleagues to ensure access to company’s products, develop and implement cross functional country plans aligned with patient, HCPs’ and broader corporate needs. The SMD is also responsible for building and encouraging scientific excellence within the team, close partnerships with HCPs, scientific societies and patient organisations in the country in which they live. They will also be responsible for financial planning and budgetary adherence of Haem medical affairs activities. They will also work closely with a International cross-functional group that includes Commercial, Market Access, Global, International Medical Affairs organizations, GAPP and Corporate Communications, Legal, Compliance (OBIE), Regulatory, Research & Development, HRBP and Finance. The individual will work closely with and report directly to the International Medical Affairs VP. Key responsibilities: Demonstrate consistent ethical and professional behavior, with uncompromising commitment to patients Ensure all medical involvement and activities are executed in full compliance with Vertex policies, local laws and regulations and codes of practice. Build reputation and visibility of Vertex at the regional and country level by providing fair and balanced medical information, communication and education to various stakeholders, supporting research and relevant data generation with the ultimate goal of supporting the safe and effective use of Vertex’ medicines in the appropriate patients Work closely with the VP GMA-I and the IMALT to ensure a culture of integrity, transparency and respect, as per Vertex values, throughout the organisation Medical Strategy Develop and ensure flawless execution, via the medical team, of the Hematological Medical Strategic and Operational Plan, aligned with the Global Medical strategy and local country plans, and in accordance with corporate policies and procedures and applicable local laws, regulations and code of practice Participate in the development of Life Cycle Management (LCM) Plans Drive data generation studies/projects to enhance medical-scientific knowledge in the Therapeutic Area(s) and ensure implementation of RWD initiatives and LCM plans in the region, as appropriate Provide feedback on Global Development Programs to ensure local needs are taken into account Scientific Excellence Develop and maintain high level, clinical and scientific knowledge in all Vertex therapeutic areas. Provide leadership to dedicated medical team as discussed above Involved in Recruitment, development, management and coaching the medical team Ensure formal goal-setting, appraisals, individual development plans (IDPs) take place in a timely and structured manner Maintain a seamless flow of information within and between the local structure and the International HQ, and communicate medical insights obtained locally from appropriate field interactions to inform local and regional strategy/ tactics External partnerships Ensure excellent working partnerships are developed with Health Care Professionals (HCPs) based on scientific excellence and trust Partner with HCPs to provide and obtain insights on therapeutic area issues and questions Establish relationships with External Experts to expand research opportunities Develop, at local level, advisory, collaborative and/or educational activities aligned to the Vertex strategy Contribute to transparent and successful partnerships with national scientific societies, patient organizations, relevant payers, policymakers and relevant industry associations Medical Communication: Provide fair and balanced medical information and education to health care professionals a nd HTA/p a ye r stakeholders t h at s u p p ort t h e s a f e a n d e ffective u s e of Vertex’ medicines in the appropriate p ati e nts External presentations (local advisory board meetings, symposia, other medical education meetings) to enhance the medical knowledge of pipeline and marketed products, as required and in accordance with local regulations and procedures Ensure adequate internal training is provided to medical and XFT, contribute individually as appropriate Compliance and Pharmacovigilance: E n s ure c o m p lian c e of medical activities at country level with country Code of Conduct, rules and regulations, company policies, S O Ps, GCP and ICH As s ess local p r omo t i o n a l materials and e n s ure t hat all claims a r e f u lly su p ported by s ci e ntific d a t a, and a r e p r e s ent e d in an a c c ur a t e, fair a nd b a l a n c ed m a nner Ensure self and other country medical staff have the required skills to identify and report AEs appropriately Contribute to managing external communication when significant safety issues arise, with the wellbeing of patients being the ultimate goal Disease State, Portfolio, Brand and Access support Work in partnership with the Country Manager as well as other cross functional team (XFT) colleagues to ensure that the appropriate patients have fair access in a safe and effective manner, develop and implement country cross functional plans aligned with patient, HCPs’ and broader corporate needs Ensure high level of support and contribution to access efforts through the preparation/review of reimbursement dossiers, scientific engagement of key stakeholders, presentation of scientific data as required to key stakeholders in the access process, incorporation of medical insights into strategy, perform data gap analysis relevant to access and support locally needed data generation as appropriate Lead accountability for reviewing and certification of promotional and non-promotional materials in the respective area according to the company SOP and to local country and regional regulations Responsible for medical interpretation of data (clinical trials, registries, published literature, etc.) for in-development compounds and marketed medicines Ensure medical team provides medical education and appropriate medical scientific support to XFT colleagues, as needed Keep product and pipeline information up to date based on internal and external publications Cross functional collaboration Work closely with internal and key external stakeholders, supporting Vertex’ strategy and bringing medical insights as well as support for HTA bodies, media, government and patient group activities, including policy development, corporate initiatives and issues management Maintain a seamless flow of information within and between the local structure and International Medical Affairs, and communicate medical insights obtained locally from appropriate field interactions to inform local, regional and global strategy/tactics Contribute to the development of the broader aims of the regional organization such as regional Haem strategy & plans, policy development, financial planning, budgeting Strategic alignment working cross functionally and partnering with other key functions at Vertex such as Commercial, Market Access, HEOR, Regulatory and Corporate Communications Ensure own and team responsibilities and goals are aligned with the long term aims of the organization and other departments Provides input and contribute to the global Therapeutic Area/s strategic imperatives, Medical Affairs objectives and tactics. Accountable for supporting the Regional Medical Lead in the development, implementation and execution of the Regional Medical Strategy and plan for pipeline and in market products Keep close interaction and communications with Global and International Medical Affairs functions Work in strategic partnership with Regulatory, Pharmacovigilance, Medical Information, Clinical Development, Global Clinical Operations and Health Economics Outcomes Research teams in medical scientific questions Support for issues related to supply and distribution, product quality, benefit-risk, market actions and product withdrawals Other Medical activities: Facilitate appropriate and adequate implementation of compassionate use programmes in country Ensure sourcing accurate epidemiology data in collaboration with local registries/other stakeholders, as applicable Ensure medical team supports Investigator Initiated research aligned with strategic areas of interest and in a compliant fashion Ensure appropriate Steering Committee meetings and advisory boards are held in accordance with local and company

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London, England, London, SW1V, United Kingdom

  • Ad ID:  18482444
  • Ad Type:  Offered
  • Posted on:  23/12/2020, 02:49
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