GenMed TA Lead

Accountabilities

• 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
• Therapeutic Area Medical budget allocation
• Approve appropriate documents (Plans, Goals, SOP’s, contracts)
• 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