The TA Head is the single point of Medical accountability for the General Medicine Therapeutic Area(Cardiovascular, Bone & Inflammation) in the South Korea. The Medical TA Head drives the development and execution of TA medical strategies to maximize Amgen's value proposition of in-line and pipeline products in alignment with product/franchise strategies.
Responsibilities
Ensure development and execution of patient-focused Therapeutic Area 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 appropriate cross-functional teams and governance, ensuring alignment of early-stage strategy with late-stage TA objectives
Partner with cross functional stakeholders to shape the healthcare ecosystem by enabling access to medicines through evidence generation, communication and education of medical and economic value
Provide strategic input into key, high-impact insights and ensure robust staff competency
Foster and enhance collaboration and coordination across Medical
Set the strategy for scientific engagement across a broad range of stakeholders to strengthen external understanding of the unmet need and value of the product
Lead relationships with external healthcare community, including interactions with opinion leaders, payers, societies and industry associations for scientific exchange
Develop and lead execution of the strategy for medical evidence generation that shapes our products and informs the practice of medicine ensuring alignment of early-stage strategy with late-stage TA objectives; Contribute as a key member of the AUEG Governance Meeting
Foster Amgen‘s reputation as a science-based, innovative and patient-focused reliable partner
Provide strategic input into development of advocacy plans and strategies in partnership with internal stakeholders and lead relationships as appropriate
Partner with Global Regulatory Affairs and Safety (GRAAS) in risk management/minimization activities and ensure communication of the implications to internal/external stakeholders
Provide clinical oversight of product safety evaluation within the South Korea Gen Med TA
Member and Medical representative of relevant leadership, governance and cross functional teams
Develop and manage medical therapeutic area budget and resources
Recruit, retain, coach, mentor, motivate and develop talent
Ensure conduct of medical activities in full compliance of all laws, regulations and SOPs
Ensure therapeutic area and product specific medical training
Provide strategic input into labels/regulatory/reimbursement/policy/promotional used to support internal/external interactions
Ensure 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
At a therapeutic area level, establish cross-product strategy for, review, approve, and ensure dissemination of medical communications deliverables (eg, product narrative, scientific platform, core content, publications including FPR/FLR, medical education and congresses)
Perform portfolio level risk assessments and prioritization of programs across TA
Provide strategic input into data interpretation and analysis
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 leadership team, ensure informed budget/resource trade-offs
Develop and execute Medical staff engagement plan, as appropriate
Direct medical teams in navigating products through internal governance and external regulatory interactions as appropriate
Ensure scientific/clinical oversight for due diligence in partnership with Business Development and ensure support for partner relationships, as appropriate
Contribute to lifecycle management plan
Authority
Therapeutic Area resource allocation/talent and staff management and hiring decisions
Signs off on Direct Outside Expense at signature level
Scientific/medical approval of materials used internally/externally
Approve Medical strategy (eg, Evidence Generation, Communication, Engagement, Publication)
Approve/Develop (as appropriate) clinical content of local regulatory agency briefing documents, submissions and interactions (Local)
Qualifications
Minimum Requirements
Doctor of Medicine (MD)
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
3 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Demonstrated leadership experience
Preferred Requirements
Doctorate degree
Accredited fellowship in respective product, board certified or board eligible
Demonstrated ability as a medical expert in a complex matrix environment
Pharmaceutical product development, product lifecycle and commercialization process knowledge/proven experience with advanced understanding of other functions; including, but not limited to, Clinical Operations, Commercial, Safety, Regulatory, Value & Access, and Medical Affairs
Therapeutic area knowledge
Expertise in regional 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
In-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trials
Sound scientific and clinical judgement
Knowledge of Good Clinical Practices (GCP), region regulations and guidelines, and applicable international regulatory requirements
Knowledge 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 therapeutic area