Therapeutic Area Medical Sr Mgr

Career Category Medical Affairs Job Description HOW MIGHT YOU DEFY IMAGINATION? You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Accountabilities The Medical Advisor is a point of medical contact for their allocated product(s). The Medical Advisor leads adaptation of global /regional strategy to reflect local/regional priorities for their product(s) and/or supports execution of those strategies to maximize Amgen's value proposition of inline an d pipeline products in alignment with product strategies. Live What you will do Let’s do this. Let’s change the world. In this vital role you will communicate information about our science and products to medical community and provide field observations to internal partners serving patients: Responsibilities 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 Competencies Scientific and Technical Expertise Understanding of external landscape impacting Amgen products Deep knowledge of relevant Amgen assets, disease state, and medical specialties Medical Affairs expert Deep and broad understanding of evidence generation process Knowledge of compliance, safety and regulatory within locale Pharmaceutical product development, product lifecycle and commercialization process knowledge with advanced understanding of other functions; including Global Development, Commercial, Safety and Regulatory Strong analytical skills Deep understanding of reimbursement/access/payer environment Business Acumen Deep awareness of objectives, goals, challenges and financial constraints as well as understanding the need to measure performance and adopt a continuous improvement mentality Corporate maturity and savvy Strategic thinking (eg, ability to form/convey strategic insights, analyze problems and make decisions) Take appropriate risks Understanding of global context and ability to translate across geographies Deep understanding of brand strategy Operational excellence: management skills, planning, prioritization, decision making, objective setting, meeting management and plan execution Skilled at leveraging medical content and appropriately shaping to inform/guide communication with external medical community Creating a Collaborative and Enabling Climate Establish an enabling environment as a role model of Amgen’s Values, Leadership Attributes and Operating Model behaviors Enable engagement and self-motivation of others Build, manage and lead high performing teams/individuals Provides support for career path/career development Empowers appropriate risk taking/decision making Recruit, retain, coach, mentor, motivate and develop talent Ability to effectively lead through change Agility and Learning Embrace change, ambiguity Foster a culture of innovative thinking Lead and support innovation Demonstrate judgment informed by experience Foster appropriate risk tolerance Forecast and pivot Strong commitment to on-going learning and professional capability enhancement Influencing, Integrating and Facilitating Shape vision and strategy Focus with 360 perspective, including internal and external stakeholders Ensure representation of the patient perspective/”voice of patient” Optimize leadership styles Build and cultivate relationships Excellent communication and presentation skills Strong cross-functional negotiation skills, ability to skillfully navigate the executive matrix Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .