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The TA Lead is the primary point of Medical accountability for assigned Therapeutic Area (Cardiovascular) in South Korea. The Medical TA Lead 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.
Job Responsibility:
Develop and ensure the 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, scientific communication and education of medical value
Provide strategic input with high-impact insights and ensure operational excellence
Develop the strategy for scientific engagement across a broad range of stakeholders to strengthen understanding of the unmet needs and value of the product
Demonstrate medical leadership with external healthcare community, including scientific interactions with opinion leaders, payers, academic societies and industry associations for exchange
Lead evidence generation that reinforces our product position 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
Manage medical therapeutic area budget and resources
Manage subordinates, eg. MSL(s), Med Advisor(s), to maximize their potential and perform their best. Recruit, retain, coach, mentor, motivate and develop talent.
Ensure conduct of medical activities in full compliance of all laws, regulations and SOPs
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
Perform portfolio level risk assessments and prioritization of programs within the TA
Ensure scientific/clinical oversight for due diligence in partnership with Business Development and ensure support for partner relationships, as appropriate
Requirements:
Doctor of Medicine (MD) degree is highly preferred
Advanced degree (eg. PhD, PharmD, MPH) in relevant scientific areas is preferred, majoring in pharmacy or science/bio-based areas
≥ 5 years of medical affairs and/or clinical development experience in multinational pharmaceutical company(es)
≥ 2 years of direct people management experience
In-depth knowledge in clinical development, product lifecycle and commercialization process
Knowledge and deep understandings of local healthcare systems and pharmaceutical industry
Experience of assigned Therapeutic area is preferred
Knowledge of Good Clinical Practices (GCP), regulations and guidelines, and applicable international regulatory requirements
Proven ability to lead, manage, and motivate others in a complex, multi-functional, multi-national matrix environment
Prioritization, problem solving skills with strategic thinking, self-leadership/motivation
Good communication skills and fluent in English both in written and spoken
Fluency in Korean both in written and spoken is preferred
Nice to have:
Fluency in Korean both in written and spoken is preferred