Career Category
Medical Affairs
Job Description
Accountabilities
The Medical Advisor is a point of medical contact for their allocated product(s)- Oncology such as Tarlatamab and Sotorasib. The Sr Medical Advisor leads adaptation of global/regional strategy to reflect local/regional priorities for their product(s) and/or supports execution of those strategies to maximize Amgen's value proposition in alignment with product strategies.
Responsibilities
- Support development and execution of 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 Medical Product Lead and/or Medical TA Head, appropriate cross-functional teams and governance.
- Contribute to cross functional stakeholder teams in shaping the healthcare ecosystem by enabling access to medicines through evidence generation, communication and education of medical value
- Synthesize and integrate insights to deliver medical inputs into relevant cross-regional/functional strategies, including relevant brand strategy
- Foster and enhance collaboration and coordination across Medical
- Contribute to strategy development for scientific engagement across a broad range of stakeholders to strengthen external understanding of the unmet need and value of the product
- Lead/support relationships with external healthcare community, including interactions with opinion leaders, payers and societies for scientific exchange, where appropriate
- Develop/support and lead/support execution of the strategy for medical evidence generation that shapes our products and informs the practice of medicine ensuring key needs are met in alignment with global product medical and relevant brand strategy
- Foster Amgen‘s reputation as a science-based, innovative and patient-focused reliable partner
- Develop and/or contribute to execution of advocacy plans and strategies in partnership with internal stakeholders and lead relationships as appropriate
- Partner with/support 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
- Ensure conduct of medical activities in full compliance of all laws, regulations and SOPs
- Ensure product/disease state/pipeline specific medical training where appropriate, may deliver training to others
- Support/Collaborate with Global Development Operations, as appropriate, for seamless execution of clinical development strategy in Korea
- Provide strategic input into labels/regulatory/reimbursement/policy/promotional used to support internal/external interactions
- Demonstrate medical leadership with external healthcare community, including scientific interactions with opinion leaders, payers, academic societies and industry associations
- 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
- Contribute to strategy development for, review, approve and ensure dissemination of, medical communications and related activities (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/support the development of data interpretation, analysis and communication for medical 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 and manage study lifecycle (including communicating with investigators, as appropriate and ensuring accurate reporting of key milestone data)
- Contribute to lifecycle management plan
Authority
- Medical Plan (i.e. Evidence Generation, Communication, Engagement, Publication)
- Approve appropriate documents (i.e. Plans, Goals)
- Approve/Develop (as appropriate) scientific/medical review of materials used internally/externally
- Protocol and other study documents for local AST, as appropriate
- Primary gatekeeper of budget control for responsible product(s)
Outputs
- Product(s) Medical strategy, plans, goals, objectives, performance metrics
- Scientific/medical input to cross-functional strategy
- Medical communication plan
- Medical engagement plan
- Clinical trial and evidence generation execution
Qualifications
Minimum Requirements
- Doctor of Medicine (MD) ≥ 3 years OR PharmD, or PhD with ≥ 5 years of medical affairs or clinical development experience and education in relevant therapeutic area in a pharmaceutical or biotechnology company
Preferred Requirements
- Experience in oncology therapeutic area
- Demonstrated ability as a medical expert in a complex matrix environment
- Pharmaceutical product 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 area knowledge
- Experience in regional/local medical practice and healthcare ecosystems
- Skilled at engagement, scientific exchange with external medical community
- 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
- 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
Competencies
Scientific and Technical Expertise
- Understanding of external landscape impacting Amgen products
- Deep knowledge of relevant Amgen assets, disease state, and medical specialties
- Medical Affairs expert
- Deep and broad understanding of evidence generation process
- Knowledge of compliance, safety and regulatory within locale
- Pharmaceutical product development, product lifecycle and commercialization process knowledge with advanced understanding of other functions; including Global Development, Commercial, Safety and Regulatory
- Strong analytical skills
- Deep understanding of reimbursement/access/payer environment
Business Acumen
- Deep awareness of objectives, goals, challenges and financial constraints as well as understanding the need to measure performance and adopt a continuous improvement mentality
- Corporate maturity and savvy
- Strategic thinking (eg, ability to form/convey strategic insights, analyze problems and make decisions)
- Take appropriate risks
- Understanding of global context and ability to translate across geographies
- Deep understanding of brand strategy
- Operational excellence: management skills, planning, prioritization, decision making, objective setting, meeting management and plan execution
- Skilled at leveraging medical content and appropriately shaping to inform/guide communication with external medical community
Creating a Collaborative and Enabling Climate
- Establish an enabling environment as a role model of Amgen’s Values, Leadership Attributes and Operating Model behaviors
- Enable engagement and self-motivation of others
- Build, manage and lead high performing teams/individuals
- Provides support for career path/career development
- Empowers appropriate risk taking/decision making
- Recruit, retain, coach, mentor, motivate and develop talent
- Ability to effectively lead through change
Agility and Learning
- Embrace change, ambiguity
- Foster a culture of innovative thinking
- Lead and support innovation
- Demonstrate judgment informed by experience
- Foster appropriate risk tolerance
- Forecast and pivot
- Strong commitment to on-going learning and professional capability enhancement
Influencing, Integrating and Facilitating