CV Therapeutic Area Lead

r 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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