Therapeutic Area Medical Sr Mgr

Support development and execution of patient-focused medical strategies that maximize the value proposition of Amgen's therapies including annual strategic planning and goal setting, launch support and lifecycle management, in collaboration with Medical Product Lead and/or Medical TA Head, appropriate cross-functional teams and governance Contribute to cross functional stakeholder teams in shaping the healthcare ecosystem by enabling access to medicines through evidence generation, communication and education of medical and economic value Synthesize and integrate insights to deliver medical inputs into relevant cross-regional/functional strategies, including relevant brand strategy Foster and enhance collaboration and coordination across Medical Contribute to strategy development for scientific engagement across a broad range of stakeholders to strengthen external understanding of the unmet need and value of the product Lead/support relationships with external healthcare community, including interactions with opinion leaders, payers and societies for scientific exchange, where appropriate Develop/support and lead/support execution of the strategy for medical evidence generation that shapes our products and informs the practice of medicine ensuring key needs are met in alignment with global product medical and relevant brand strategy Foster Amgen‘s reputation as a science-based, innovative and patient-focused reliable partner Develop and/or contribute to execution of advocacy plans and strategies in partnership with internal stakeholders and lead relationships as appropriate Partner with/support Global Regulatory Affairs and Safety (GRAAS) in risk management/minimization activities and ensure communication of the implications to internal/external stakeholders Member and Medical representative of relevant leadership, governance and cross functional teams May develop and manage medical product budget Recruit, retain, coach, mentor, motivate and develop talent, as appropriate Ensure conduct of medical activities in full compliance of all laws, regulations and SOPs Ensure product/disease state/pipeline specific medical training where appropriate, may deliver training to others Ensure appropriate clinical trial conduct as a key medical interface in close partnership with Global Development Operations (eg Site Management) Provide strategic input into labels/regulatory/reimbursement/policy/promotional used to support internal/external interactions Determine scientific/medical subject matter appropriateness of labels/regulatory/reimbursement/policy/promotional and medical deliverables (eg, slide decks, publications, educational activities) used to support internal/external interactions via appropriate review process Contribute to strategy development for, review, approve and ensure dissemination of, medical communications and related activities (eg, product narrative, scientific platform, core content, publications including FPR/FLR, medical education and congresses) Provide support and leadership of advisory boards and other relevant meetings (eg, investigator meetings, and/or expert panels) Lead/support the development of data interpretation, analysis and communication for medical executed studies Provide decision on IME, Donations, medical grants and sponsorships, where appropriate Utilize global infrastructure for tracking, measuring and evaluating performance and ensure continuous performance improvement Understand the expectations of key external stakeholders to support appropriate access to Amgen therapies. In partnership with cross-functional team, ensure informed budget/resource trade-offs, as appropriate Facilitates Investigator Sponsored Studies through Amgen governance and manage study lifecycle (including communicating with investigators, as appropriate and ensuring accurate reporting of key milestone data) Contribute to lifecycle management plan Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The ambitious professional passionate about medical science whom we seek is a strategic, science-driven medical leader with the following qualifications. Qualifications The assignment of GCF Level for this discipline requires a role assessment with Human Resources. The assessment will evaluate the overall scope and organizational impact of the role, including but not limited to, the size and complexity of the applicable local market(s), product(s), and/or pipeline portfolio. Please contact your HR Business Partner to initiate this assessment. He or she will involve your local HR Compensation team as needed. Minimum Requirements Doctorate degree 5 years of medical affairs or clinical development experience and education in relevant therapeutic area, 1+ years of which should be from a pharmaceutical or biotechnology company 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Requirements Doctor of Medicine (MD) Demonstrated a bility as a medical expert in a complex matrix environment Pharmaceutical product development, product lifecycle and commercialization process knowledge with understanding of other functions; including, but not limited to, Clinical Operations, Commercial, Safety, Regulatory, Value & Access, and Medical Affairs Product/therapeutic area knowledge Experience in regional/local medical practice and healthcare ecosystems Skilled at engagement, scientific exchange with external medical community Clinical research experience In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale Familiarity with concepts of clinical research and clinical trial design, including biostatistics Sound scientific and clinical judgement Knowledge of Good Clinical Practices (GCP), region regulations and guidelines, and applicable international regulatory requirements Familiarity of local pharmaceutical industry and legal/health system environment Finance/budgeting and resource management experience Proven ability to lead, manage, and motivate others in a complex, multi-functional, multi-national matrix environment Skilled at effectively presenting ideas and documenting complex medical/clinical concepts in both written and oral communication History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues Network of medical, clinical contacts in product/therapeutic area