Job Description / Capsule At AstraZeneca, we are focused on the potential of science to address the unmet needs of patients worldwide. We are committed to areas where we believe we can truly change the course of medicine and bring new ideas to life. The Early Asset Medical Affairs Manager is a scientifically experienced professional that will lead the early medical strategy regarding compounds/products under his/her responsibility as well as medical & scientific matters regarding early assets development. This includes providing sound medical and scientific advice to the organization, ensuring adequate medical input in the Market Shaping Team to contribute to the success of future launches.
This role will ensure clinical stakeholder´s early engagement, playing a critical role in bridging the gap between the clinical development of an asset and its medical and scientific impact.
Accountabilities Strategic Site Selection & Recruitment AccelerationCollaborate with Global R&D, Early Asset Lead and Local SMM in strategic site selection and site recruitment acceleration.Provide early local insights on new therapeutic areas, disease journey, clinical pathway, and trials design.Ensure clinical stakeholder's early engagement to streamline trial operations and foster timely execution.Medical Affairs Input & Market ShapingRepresent Medical Affairs input in the Market Shaping Team, providing medical and scientific advice to the organization, ensuring adequate medical input of all scientific activities and asset prioritization evaluation.Ensure early scientific positioning of product/indication aligned with defined AZ positioning (e.g. target patients for new indications).Generate awareness of unmet therapeutic needs and therapeutic value offered by the drug in the pathology.External Stakeholder Engagement & KEE DevelopmentParticipate in the identification, mapping, early engagement and development of the national relevant KEEs of the therapeutic area.Serve as the main point of contact for external experts, conducting peer-to-peer scientific dialogue and addressing unsolicited requests for information on early assets under responsibility.Act as a critical role bridging the gap between the clinical development & operations of an asset and its medical and scientific plans, while also being the internal and external interface between medical affairs, Global R&D/SMM.Preparation for Future Product LaunchesShare insights and influence global teams on the designs and development of Phase III studies in the therapeutic area entrusted to him/her to meet the expectations of the local environment by:Having an in-depth knowledge of the environment and current and future processing standards.Participating in strategic design meetings of studies.Identifying evidence GAPs at national level to prioritize local evidence generation.As soon as the design of the Phase III is validated, ensure to actively contribute to the preparation of the Spanish healthcare ecosystem for the future indications of the therapeutic area entrusted to it by:Providing medical input of early development and clinical insights to the market shaping teams, anticipating the information needs of payers, regulators and prescribers throughout the life cycle of the product(s).Responsible for the development and execution of pipeline medical affairs strategies and plans that clearly support pipeline molecules development adding value for patients and customers.Anticipating the necessary environmental readiness activities and deploying medical projects to contribute to the success of future launches.Contribution to the elaboration of the early medical plans for the therapeutic area as well as the activities necessary to achieve it.Structuring a continuous scientific/medical watch of the positioning and activities of other pharma companies present in the therapeutic area.Contribute to the implementation and proper monitoring of the budgets necessary for the implementation of the activities for which he/she is responsible.ComplianceResponsible for internal and external interactions of the team, regularly evaluating business/compliance risks to enable teams to operate accordingly.Ensure own and team's compliance with AstraZeneca's Code of Conduct and company policies and procedures relating to people, finance, technology, security and Safety, Health and Environment.Education, Qualifications, and Experience Essential Advanced degree in Medicine, Pharmacology, Pharmacy, Biological sciences or equivalent experience.Professional experience: > 5 years of experience in the pharmaceutical industry within the medical department, experience in product launches.At least 4+ years of Oncology therapeutic area experience (academic research, clinical or pharmaceutical/biotech industry).Knowledge of the healthcare sector and future needs and challenges.Deep scientific expertise and knowledge of the environment in the therapeutic area.Strong strategic vision.Knowledge of clinical trial regulations and market access environment.Ability in problem solving, analytical skills, scientific rigor.Ability to work optimally in a cross-functional team environment.Demonstrated leadership abilities in a matrix organization.Collaboration and teamwork mindset: foster teamwork and contribute to establish open communication.Communication skills: ability to effectively articulate complex scientific and medical information.Availability for 50% time travelling.Demonstrated strong business acumen and integrative thinking to address identified data gaps and optimize strategic plans.Desirable Results-oriented mindset.Learning agility.Adaptability and flexibility.Critical thinking.Skills and Capabilities Essential Strong strategic vision.Knowledge of clinical trial regulations and market access environment.Ability in problem solving, analytical skills, scientific rigor.Ability to work optimally in a cross-functional team environment.Demonstrated leadership abilities in a matrix organization.Collaboration and teamwork mindset: foster teamwork and contribute to establish open communication.Communication skills: ability to effectively articulate complex scientific and medical information.Availability for 50% time travelling.Demonstrated strong business acumen and integrative thinking to address identified data gaps and optimize strategic plans.Desirable Results-oriented mindset.Learning agility.Adaptability and flexibility.Critical thinking.Key Relationships to reach solutions Internal (to AZ or team) Global R&D/local SM&M.Medical Affairs Function.Market shaping Team.Global and regional medical teams within Oncology therapeutic area.External (to AZ) External critical stakeholders, Healthcare professionals.Key providers.Scientific Societies and research organizations.
#J-18808-Ljbffr