Career Category
Medical Affairs
Job Description
Live
What you will do
Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a TA Medical Lead, Bone Health & Rare Disease (Malaysia & Singapore). This role is based in Malaysia.
Live
What you will do
Accountabilities
The TA Medical Lead is a point of medical contact for their allocated product(s). The TA medical Lead 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 of inline and pipeline products 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 and economic 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
- May 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
- 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
- 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
Win
What we expect of you
Minimum Requirements
- Doctorate degree & 3 years of directly related experience
- Bachelor’s degree & 5 years of directly related experience
- Based in Malaysia, with the ability to travel within the country, and between Malaysia & Singapore
Preferred Requirements
- 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
- 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
- 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
Thrive
What you can expect of us
As we work to develop treatments that take care of others so we work to care for our teammates’ professional
and personal growth and well-being.
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
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