CV Therapeutic Area Lead

Career Category

Medical Affairs

Job Description

Cardiovascular Therapeutic Area Lead

Accountability

• 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.

Responsibilities

• 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

Authority

• Therapeutic Area resource allocation/staff management and hiring
• Therapeutic Area Medical budget allocation
• Approval of documents (Plans, Goals, SOP’s, contracts) as appropriate
• Sign off on Direct Outside Expense at allocated signature level
• Scientific/medical approval of materials used internally/externally
• Ownership of Medical strategy (e.g. evidence generation, scientific communication including publications, engagement of healthcare professionals and authorities, etc.)
• Approve/Develop (as appropriate) clinical content for local health authority briefing documents, submissions and interactions (Local)

Qualifications and 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

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