Therapeutic Area Medical Sr Mgr

Career CategoryMedical AffairsJob 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 und