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Medical Affairs Medical Director, Cardiometabolic

2 months ago

Washington DC, United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger and purposeful, its because you are. At Amgen, our shared missionto serve patientsdrives everything we do. It is vital to 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.

Medical Affairs Medical Director - Repatha

Live

What you will do

Lets do this. Lets change the world. In this vital role you will support the development and delivery of the US CV & Metabolic medical affairs strategy assets (including evidence generation, medical communication, and external engagement. Support Medical Affairs strategies by enhancing molecule value proposition, including planning and goal setting, launch support, and lifecycle management, in collaboration with US Medical Lead and/or Medical TA Head and in alignment with Global strategy

  • Support definition of scientific evidence gaps, development of local evidence generation strategy in coordination with global strategy
  • Develop and lead/support evidence generation that shapes product and informs the practice of medicine, ensure key needs are met in alignment with global and local medical and brand strategy
  • Synthesize and integrate insights to deliver medical inputs into cross-regional/functional strategies, including brand strategy
  • Cultivate and improve collaboration and coordination across medical functions
  • Contribute to strategy development for scientific engagement across a broad range of partners, to strengthen external understanding of the unmet need and value of the product
  • Lead/support relationships with the external healthcare community, including interactions with opinion leaders, payers, and societies for scientific exchange
  • Support clinical trial conduct as a key medical interface in close partnership with Global Clinical Development and CfOR teams; contribute to study data interpretation, analysis, and communication
  • Facilitate Investigator Sponsored Studies through Amgen governance
  • Partner with/support Global Regulatory Affairs and Safety (GRAAS) in product risk management/minimization activities and ensure communication of the implications to partners
  • Provide strategic feedback into labels, regulatory, reimbursement, policy and promotional materials
  • Active member of MAC team. Determine scientific/medical subject matter appropriateness of promotional and medical deliverables (e.g., slide decks, publications, educational activities)
  • Review, approve, and ensure dissemination of medical communications and related activities (e.g., product narrative, scientific platform, core content, publications including FPR/FLR, medical education, and congresses)
  • Lead product/disease state/pipeline specific medical training, may deliver training to others
  • Lead or support advisory boards and other meetings (e.g., investigator meetings, expert panels)
  • Contribute to the development and/or delivery of advocacy plans and strategies in partnership with internal collaborators and lead relationships
  • Support decisions on IME, donations, medical grants, and sponsorships
  • With a cross-functional team, ensure informed budget/resource trade-offs, may also develop and handle medical product budget
  • Serve as a medical representative in leadership, governance, and cross-functional teams
  • Ensure the conduct of medical activities in full compliance with all laws, regulations, and SOPs
  • Use global infrastructure for tracking, measuring, and evaluating performance and ensuring continuous performance improvementWin

    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 four years of Medical Affairs and/or related clinical research experience and/or basic Cardiovascular science research experience

    OR

    Masters degree and 8 years of Medical Affairs and/or related clinical research experience and/or basic Cardiovascular science research experience

    OR

    Bachelors degree and 10 years of Medical Affairs and/or related clinical research experience and/or basic Cardiovascular science research experiencePreferred Qualifications:

  • PharmD, MD/DO or PhD with extensive experience in the cardiometabolic space
Clinical and disease knowledge base in cardiovascular disease states5 years Medical Affairs and or MSL experience in the US biopharmaceutical industry (biotech, pharmaceutical, or CRO) including collaborations with integrated delivery networks, accountable care organizations, and/or payersPharmaceutical product development, product lifecycle and commercialization process knowledge with advanced understanding of other functions; including, Clinical Operations, Commercial, Regulatory, and Medical AffairsExperience with stakeholder engagement and interactions (e.g., opinion leaders, advocacy groups, payers)Broad and formal leadership experience, including opinion leader interactionsFamiliarity with global regulatory organizations, guidelines, and practicesKnowledge of Good Clinical Practices (GCP) and global regulations and guidelinesHistory of solving problems while exhibiting sound judgment and a balanced, realistic understanding of issuesTrack 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. (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 now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.careers.amgen.comApplication 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.