Medical Advisor Mielofibrosis

Site Name: GSK Tres Cantos, Madrid Posted Date: Jan 25 2023 Job Purpose: He/She is a scientifically experienced professional that will lead the medical strategy regarding compounds/products under his/her responsibility, pre and post-commercialization, as well as in medical & scientific matters regarding marketed products under his/her responsibility. This includes providing sound medical and scientific advice to the Commercial organization, ensuring adequate medical governance and risk management of all promotional and communication activities. He/She wil be responsible for the development and execution of innovative Medical affairs strategies and plans that clearly support GSK development of medicines of value for patients and customers, being accountable for the Scientific engagement activities developed in her/his responsibility area. As responsible for the development and execution of innovative Medical affairs strategies and plans that clearly support GSK development of medicines of value for patients and customers, she/he will be accountable for the Scientific engagement activities developed in her/his responsibility area. As requested by the Hematology Medical Lead, he/she will be the Med Dept representative in those relevant GSK groups, both local and European, for activities related to the products or disease areas under his/her responsibility. As appropriate, these may involve participation in the tasks of Business Unit, Medical-marketing teams, Global and regional teams or other related working groups concerning products under his/her responsibility acting as the scientific liaison between international and local market needs. He/she will closely work with the MKT/Sales/Market Access colleagues from the relevant Business Unit. He/she may also be the medical representative for the products or disease areas under his/her responsibility in the interaction with Regulatory, that may require scientific advice on the area involved. He/she will closely work with the TA monitoring team in supporting Clinical Trials and other studies according to GSK procedures, working closely with the Clinical Operations Department. He/she will be ultimately responsible for all medical & scientific matters (both Clinical and Commercial-related) regarding the product/compound/disease area(s) under his/her responsibility, including adequate Medical Governance and compliance with Pharmacovigilance & Risk Management requirements. The incumbent would be responsible for designing, planning, and leading/co-ordinating his/her Area activities (within his/her team, with R&D and with the Commercial organization) as to ensure that a consolidated opinion (medical & commercial) is voiced to GSK and externally. Key Responsibilities 1.- Full understanding of the Local strategic needs of the Therapy Area and the products under his/her responsibility, being: Member of pre- and post-launch local business/project teams. Medical Dept expert on competitors of the products under his/her responsibility. Full involvement in MKT plans design with relevant BU colleagues (supervised by the Hematology Medical Lead). Active member of international or European teams within the Therapy Area or dealing with the products under his/her responsibility, when requested by the Hematology Medical Lead. Scientific support to products according to Business Unit (s) strategies (supervised by the Hematology Medical Lead). This would include, but are not limited to, generation of projects’ background, generation of manuscripts, selection of speakers and design of lectures for scientific presentations, development of disease awareness projects and scientific coordination of scientific projects. 2.-Support the performance of clinical trials under GSK quality standards (SOPs), providing with medical input to those aspects of clinical trials and other studies as required by Clinical Operations Department. Provide scientific and medical support to projects included in the dossier of the “Profarma” Plan. Provide medical support to both Local Safety Teams, if requested. Design, conduct, manage and publish studies previously agreed with the Business Unit and supervised by the Hematology Medical Lead. Management of clinical and non-clinical unsolicited studies, requests for reference standards and compassionate use requests, submit ISS/SCS proposals as agreed with the Business Unit and the Hematology Medical Lead. He/she will be responsible for ensuring that all proposals approved are conducted following GSK procedures. Medical responsibility on local studies/ISS/SCS which involves study SAEs review to detect and to manage sentinel events properly. 4.- Conduct peer to peer robust scientific dialogue with external experts, selected according to their relevant experience and uses this to generate insights and secure advice that informs GSK development of medicines of value, for the ultimate benefit of patients, and interacts with Scientific Societies. 5.- Answer to external queries that cannot be resolved by the Medical Information Service. 6.- Sales force and MSL training in medical topics, as requested by the respective Training Dept or Heads. 7.- Review and approval of promotional materials, press releases, and sales reps training (disease area, product) materials. 8.- Support to Market Access (e.g. elaboration of reports for hospital formularies, production of clinical expert reports, assessment of dossiers’ clinical data, elaboration of clinical reports for Health Authorities, review of local SPC of marketed products, VEO studies). 9.- Medical Department expert on competitors of the products under his/her responsibility 10.- Permanent scientific update on his/her medical area to identify new unmet medical needs and business opportunities: Attend to major scientific events within his/her therapy area Supports in a timely and accurate manner, to unsolicited request for on or off-label information or safety concerns from HCPs. Supports the MSL Head to coordinates all the scientific/medical activities of Medical Scientific Liasons (MSLs) Harmonize practices and training in order to ensure the same quality of services delivered to the Regions. Captures feed-back from the regions through his/her team in order to ensure that customers’ needs are taken into consideration. Scientific presentations to hospitals/symposia, if required. Knowledge/ Education / Previous Experience Required Medical Doctor, Bachelor's degree with equivalent in Pharmaceutical Industry Experience. Anyone close to the Hematology Therapeutic Area (Myelofibrosis) Other Job-Related Skills/Background Scientific & Clinical Expertise Knows the disease, its prognosis and its impact on patients’ lives from first presentation through typical treatment pathways. Is up to date with scientific/ clinical advances and anticipates their impact on disease management and guidelines. Critiques scientific data with confidence, including the appropriateness of the research methodologies used. Understands unmet medical needs in that disease area (or condition). Product & Therapeutic Area Expertise Has in-depth knowledge of GSK products in that area including the Phase I-IV studies completed and planned. Understands the populations and endpoints selected and the claims they support. Understands the risk: benefit profiles of GSK and competitor products in each therapeutic class and (patient) population. Knows the GSK and competitor pipelines and the desired positioning of new medicines/ indications in future guidelines. Evidence Generation Anticipates the information needs of payers, regulators and prescribers throughout the life-cycle of the product(s). Demonstrates strong business acumen and integrative thinking to address identified data gaps and optimise strategic plans. Designs/ informs studies that will deliver the data required to make evidence-based treatment decisions. Utilises study methodologies and approaches that clearly demonstrate the value of our products in defined populations. Value & Access Integrates information from multiple sources to communicate a compelling value proposition that supports the positioning of GSK product(s) in formularies and guidelines. Understands the business, political and health policy environments and anticipates changes that may impact future evidence needs. Develops plans to expand market access for appropriate populations driven by unmet needs and robust scientific data. Medical Governance Holds self and others accountable for ensuring compliance with required GSK Policies/ Standards and external regulations. Applies good judgment: seeks solutions that meet business needs whilst remaining compliant with GSK Values and principles. Understands the Medical Governance Framework and escalates areas of concern appropriately for clarification and resolution. Establishes appropriate oversight and monitoring. Operational Excellence Designs, delivers and informs high quality medical plans, activities and materials that are on time and on budget. Applies metrics effectively to ensure delivery and to communicate progress to stakeholders. Enhances business performance through simplification and continuous process improvement. Impactful Communications Is skilled at communicating with external medical audiences through multiple channels (including digital). Translates complex science into messages that resonate and / or articulates the value of our products clearly and concisely. Responds to questions confidently and appropriately using expert knowledge and sound judgement. Engagement Skills Has meaningful external engagements that build insight, understanding and trust – enabling effective partnership. Plans and executes engagements effectively using the Medical Engagement Framework. Uses insight gathering questions and clinical facilitation skills to ensure effective 2-way dialogue both 1:1 and 1:Many. • Computer literate –Word, Excel, PowerPoint, Outlook. • Excellent knowledge of written and spoken English and Spanish • Excellent organization skills, ability to prioritize • Flexible and proactive working attitude • Effective team member with good interpersonal skills • Attention to detail • Demonstrated ability to organize and facilitate/conduct tactics • Ability to understand and follow policies and procedures GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. 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