Medical Asset Lead Director, Cardiology

The Medical Asset(s) Lead is the single point of Medical accountability for their allocated product(s). The Medical Asset(s) Lead drives the development and execution of product Medical strategies to maximize Amgen's value proposition of in-line and pipeline products in alignment with product strategies across relevant geographies.

Responsibilities

• Develop, execute and/or support patient-focused 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 geographic medical leadership (eg, GMAL, regional Asset Lead, Medical TA Head) and appropriate cross-functional teams and governance
• 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
• Synthesize and integrate insights to deliver medical inputs into relevant cross-geography/functional strategies, including regional brand strategy
• 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 and societies for scientific exchange where appropriate
• Develop, lead or support execution of the strategy for medical evidence generation that shapes our products and informs the practice of medicine ensuring key regional/local needs are met in coordination appropriate geographic medical leadership (eg, GMAL, regional product lead, Medical TA Head)
• Foster Amgen's reputation as a science-based and patient-focused reliable partner
• Develop, execute or contribute to 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
• Member and Medical representative of relevant leadership, governance and cross functional teams
• Develop and manage medical product budget
• Recruit, retain, coach, mentor, motivate and develop talent, as appropriate
• Ensure conduct of medical activities in full compliance of all laws, regulations and SOPs
• May provide input during the negotiation of the pediatric plan with regulatory authorities and lead timely execution of plan
• Ensure product/disease state/pipeline specific medical training where appropriate, may deliver training to others
• Ensure appropriate clinical trial conduct as a key medical interface in close partnership with Global Development Operations (eg Site Management)
• Provide strategic input into labels/regulatory/reimbursement/policy/promotional used to support internal/external interactions, as appropriate
• Determine 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
• Establish 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)
• Provide support and leadership of advisory boards and other relevant meetings (eg, investigator meetings, and/or expert panels)
• Lead the development of data interpretation, analysis and communication for regionally executed studies
• 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 team, ensure informed budget/resource trade-offs, as appropriate
• Facilitates Investigator Sponsored Studies through Amgen governance (eg, KEG) and manages study lifecycle (including communicating with investigators, as appropriate and ensuring accurate reporting of key milestone data)
• May provide input into site selection for Amgen Sponsored Studies (AST)
• Lead cross-functional Medical Teams as relevant
• 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

Qualifications

• Doctorate degree
• 6 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
• 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Requirements

• Doctor of Medicine (MD), Board Certified Cardiologist
• Demonstrated ability as a medical expert in a complex matrix environment
• Pharmaceutical asset development, product lifecycle and commercialization process knowledge with understanding of other functions; including, but not limited to, Clinical Operations, Commercial, Safety, Regulatory, Value & Access, and Medical Affairs
• Product/Therapeutic knowledge in Heart Failure products
• Experience in regional/local 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
• Familiarity with concepts of clinical research and clinical trial design, including biostatistics
• Sound scientific and clinical judgement
• Knowledge of Good Clinical Practices (GCP), region regulations and guidelines, and applicable international regulatory requirements
• Familiarity 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 product/therapeutic area

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.