Senior Medical Scientist - Omecamtiv Mecarbil (OM)

The Senior Medical Scientist is accountable to support the development and execution of the global medical strategy of the Omecamtiv Mecarbil Global Medical Team (GMAT) to maximize Amgen's value proposition.

Responsibilities:

• Contribute to global medical strategy through deep understanding of clinical practice in multiple healthcare ecosystems to maximize access and reimbursement at global level
• Support the Global Medical Affairs (Product) Team
• Support the development and execution of global medical strategy, including external stakeholder management, communication, evidence generation, medical education, and value and access
• Support the development and execution of a global medical communication strategy including clinical narrative framework, scientific platform, core content, publications, congresses and other scientific events
• Support external stakeholder engagement strategy to strengthen external understanding of the unmet need and medical value of the product to appropriate patients, OLs, advocacy groups, patient affairs, medical societies, payers, policymakers and healthcare providers
• Support the build-up of Amgen's reputation as a science-based and patient focused reliable partner
• Support the development and execution of non-registrational evidence generation strategy, including the assessment of Investigator Sponsored Studies.
• Support the development and execution of medical educational strategy
• Support the development and execution of medical advisory boards
• Support the development and execution of Omecamtiv Mecarbil competitive research grant program

Basic Qualifications

MD/DO degree from an accredited medical school OR PhD OR PharmD

AND

2 years of medical affairs or clinical research experience

Preferred Qualifications

• Experience in cardiovascular therapeutic area (esp. heart failure)
• Experience with stakeholder engagement and interactions (e.g. opinion leaders, advocacy groups, payers)
• In-depth understanding of scientific method and clinical applications based on medical, scientific and practical rationale
• Familiarity with concepts of clinical research, clinical trial design, real world evidence and biostatistics
• Sound scientific/medical judgment
• Familiarity with regulations and guidelines that govern pharma industry practices
• Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
• Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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
• 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

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

MD01

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