Job Information
Amgen Senior Medical Advisor in Seoul, South Korea
Accountabilities
The Medical Advisor is a point of medical contact for their allocated product(s)- Hematology, such as Carfilzomib and Blinatumomab. The Sr 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 and pipeline products in alignment with product strategies.
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 as needed 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
Authority
Medical Plan (eg, Evidence Generation, Communication, Engagement, Publication)
Approve appropriate documents (Plans, Goals, SOP’s, contracts)
Approve/Develop (as appropriate) scientific/medical review of materials used internally/externally
Protocol and other study documents for local AST, as appropriate
Product(s) Medical budget allocation
Signs off on Direct Outside Expense at signature level
Outputs
Product(s) Medical strategy, plans, goals, objectives, performance metrics
Scientific/medical input to cross-functional strategy
Medical communication plan
Medical engagement plan
Product medical budget and resources
Clinical trial and evidence generation execution
Qualifications
Minimum Requirements
Doctor of Medicine (MD) or PharmD or PhD in relevant area
More than 3 years of medical affairs or clinical development experience and education in relevant therapeutic area in a pharmaceutical or biotechnology company with understanding of local healthcare system
Preferred Requirements
Experience in hematology therapeutic area
Demonstrated ability 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
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