Global Medical Affairs Lead
2 weeks ago
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 Medical Affairs Lead Tavneos (GMAL), US - Remote
Live
What you will do
Lets do this. Lets change the world. In this vital role you will be the single point of Medical accountability for Tavneos for ANCA-associated vasculitis (GPA/MPA). The GMAL drives the development and execution of product Medical strategies to maximize Amgen's value proposition in alignment with product strategies across relevant geographies. This role will be a key part of the Medical Affairs Inflammation Senior Leadership Team reporting to the Vice President, US Medical Affairs Inflammation Therapeutic Area Head.
Responsibilities:
Strategy Development and Implementation:
Leads Global Medical Affairs strategies/activities/development related to Tavneos, partnering with cross-functional leaders in Global Development, Commercial, and other functions to develop Amgens overall strategy.Serve as the Medical Affairs Representative on various global strategic teams, including Product Teams and the Evidence Generation Team.Support the development of the integrated access and use evidence generation plan for Tavneos.Capture clinical/scientific insights across all key markets and translate them into concrete strategies.Facilitate scientific engagements across a broad range of partners (e.g. KOLs, Professional Organizations, Payers, Regulators)Align and implement strategy for scientific communications and related activities.Develop medical strategic plans and ensure consistent delivery of outputs through Medical Affairs Teams.Provide strategic direction for study design and delivery for medical affairs and other global studies.Enable access to medicines through clear understanding and education of treatment value.Facilitate and continue to build Amgens role as a science-based, patient-focused partner.Provide input to Value Dossiers.Determine resource and budget allocation necessary to deliver on medical strategies.Evidence Generation and Communication:
Provide insights to Amgen's Safety and Benefit/Risk profile of the molecule.Support evidence generation that shapes Tavneos and informs the practice of medicine.Synthesize and integrate insights to deliver medical inputs into cross-regional/functional strategies.Review, approve, and ensure dissemination of scientific communications and related activities.Lead or support advisory boards and other meetings.Collaboration and Coordination:
Cultivate and improve collaboration and coordination across medical functions.Lead/support relationships with the external healthcare community.Serve as a medical representative in leadership, governance, and cross-functional teams.Compliance and Performance:
Ensure conduct of medical activities in full compliance with all laws, regulations, and SOPs.Win
What 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 or clinical development experience in inflammation, rare disease, and/or vasculitis
OR
Masters degree and 7 years of medical affairs or clinical development experience in inflammation, rare disease, and/or vasculitis
OR
Bachelors degree and 9 years of medical affairs or clinical development experience in inflammation, rare disease, and/or vasculitis
Preferred Qualifications:
5 years of clinical research and/or medical affairs experience in a leadership roleMD plus accredited fellowship in Rheumatology or related medical discipline, board certified or board eligibleClinical and disease knowledge base in Inflammatory diseasesExperience in building Integrated Evidence Generation PlansAbility to establish interactions and engagements with partners (e.g., Opinion Leaders, advocacy groups, patients, payers, vendors)Familiarity with global regulatory organizations, guidelines, and practicesKnowledge of Good Clinical Practices (GCP) and global regulations and guidelinesKnowledge 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 issuesGood understanding of healthcare systems around the world (e.g. US, EU, Asia)Track record of success working with matrixed cross-functional teamsThrive
What 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. is posted. Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, 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 now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
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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