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Global New Asset Medical Affairs Lead

2 months ago


Washington, Washington, D.C., United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Global New Asset Medical Affairs Lead - Inflammation (GNAMAL)Live

What you will do

Lets do this. Lets change the world. In this vital role you will lead the Global Medical Affairs strategies for Amgens Inflammation early and late pipeline portfolio of marketed and pipeline assets. Represents Global Medical Affairs to lead and drive the development and execution of medical strategies, to include but not limited to, CD-19 Autoimmune workstream, AMG 378, AMG 691, AMG 570, and AMG 592 to increase Amgens value proposition in alignment with product and franchise strategies. Provides leadership on strategies for evidence generation, scientific communication, Global launch execution, and external engagement. Amgen has an established portfolio of marketed products in Inflammation and is developing novel strategies for rapidly advancing the Inflammation pipeline. The successful candidate must have experience in recruiting and building medical affairs teams to support molecules as they advance into registration enabling studies, supporting marketed products, and partnering with local Medical Affairs teams to develop strategies that enable access to Amgens innovative new therapies. Finally, this role will be a key part of the Global Medical Affairs Inflammation Senior Leadership Team reporting to the Vice President, Global Medical Affairs Inflammation Therapeutic Area Head.

Serves as the Global New Asset Medical Affairs Lead (GNAMAL) on various global strategic teams, including Product Teams and the Evidence Generation Team.Leads Inflammation Global New Asset Medical Affairs strategies/activities/development related to CD-19 Workstream, AMG 592, AMG 570, AMG 691 partnering with cross-functional leaders in Global Development, Commercial, and other functions to develop Amgens overall strategy in Inflammation.Leads and ensures effective launch excellence, external partner management, scientific communication (e.g., clinical narrative framework, scientific platform, core content, Congresses, and publications), Evidence Generation, medical education, and medical insights.Gathers clinical/scientific insights across all key markets and translate them into actionable strategies. Internal Use Only General and AdministrativeFacilitates scientific engagements across a broad range of partners, including but not limited to, advisory board meetings and participation in international scientific venues strengthening our understanding of medical opportunities associated with pipeline assets.Aligns and implements strategy for medical communications and related activities, e.g., product narrative, scientific platform, core content, publications, medical education, and Congresses.Develops medical strategic plans and ensures consistent execution of outputs through Medical Affairs Teams.Contributes to Amgen's Safety and Benefit/Risk profile of a molecule and ensures communication of the implications to external partners, Support Investigator Sponsored Studies (ISS), and approve grants, if applicable.Provides strategic direction for study design and implementation for medical affairs and other global studies.Works in close collaboration with the Global Pipeline Execution Lead, or reports, on execution of clinical studies. This with the intent of providing strategic and scientific support and accelerating clinical programs.Facilitates and continues to build Amgens role as a science-based, patient-focused partner.Determines resource and budget allocation vital to deliver on medical strategies.Provides mentorship and guidance to local Inflammation Medical Affairs teams.Recruits and builds the Global New Asset Medical Affairs Inflammation team, as needed.Provides cross-product, strategic medical perspective to key commercialization forums.Provides input into strategies for ensuring reimbursement and access to Amgens Inflammation Portfolio globally.Continues to enhance Amgens reputation as a science-based, patient-focused partner.WinWhat we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree and 4 years of medical affairs experience and/or clinical research experience and/or basic science research experience OR Masters degree and 7 years of medical affairs experience and/or clinical research experience and/or basic science research experience OR Bachelors degree and 9 years of medical affairs experience and/or clinical research experience and/or basic science research experience Preferred Qualifications:MD plus accredited fellowship in Rheumatology or Dermatology or related medical discipline, board certified or board eligiblePhD/PharmD will be considered based on individuals profile10+ years of Global Medical Affairs experience in the biopharmaceutical industry (biotech, pharmaceutical)Experience with pipeline assets, or product launchesRegional experience, being responsible for affiliates within a Therapeutic AreaClinical and disease knowledge base in Inflammatory diseases, including Rheumatology, Dermatology, and GastroenterologyExperience with stakeholder engagement and interactions (e.g., OLs, advocacy groups, payers)Familiarity with global regulatory organizations, guidelines, and practicesKnowledge of Good Clinical Practices (GCP) and global regulations and guidelines Internal Use Only General and AdministrativeKnowledge of pharmaceutical product development, product lifecycle, and commercialization processes, including but not limited to, Clinical Operations, Commercial, Regulatory, and Medical AffairsHistory of solving problems while exhibiting sound scientific/medical judgment and a balanced, realistic understanding of issuesIn-depth understanding of scientific method and clinical applications based on medical, scientific, and practical rationaleTrack record of successfully working with matrixed cross-functional teamsThriveWhat you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.A discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply nowfor a career that defies imagination Objects in your future are closer than they appear. Join us. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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