Asset Lead Medical Director - Cardiovascular
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. Join us.Live
What you will do
Lets do this. Lets change the world. In this vital role you will be accountable for the development and execution of global medical affairs strategies including US launch and lifecycle manage.Asset Lead Medical DirectorResponsibilities:
Supporting the development and execution of US product medical strategy, via the US Medical Plan, including launch support and lifecycle management, in collaboration with Product Team, Portfolio Governance and alignment with Global strategy
Supporting definition of scientific evidence gaps, development of local evidence generation strategy in coordination with Global
Supporting clinical trial conduct
Participating in engagement of external key stakeholders
Participating in development of data communication strategy
Supports Medical input into label and regulatory interactions, in alignment and with deep understanding of global strategy and program clinical trial data
Supports implementation of Medical governance for respective product, which includes:
Safety and pharmacovigilance as a key and effective partner with GRAAS
Clinical trial conduct
US risk management/minimization in collaboration with GRAAS
Subject matter appropriateness (medical/scientific) of external interactions (e.g. copy review, multichannel, congresses, 1-1 interactions, etc.)
Ensuring appropriate medical support of compliance
Maximizes Amgens value proposition of respective product(s) through management and delivery of all medical and scientific activities , including launch and lifecycle management, in alignment with Global strategy and Evidence Generation Team (EGT)
Participates in development of US cross functional strategy and supports medical execution.
Provides input into medical and scientific insight for incorporation into US product strategies, via the US Medical Plan, and provides insights into Global strategies, plans and tactics as a participant in the Commercialization process
Executes product-specific US evidence generation strategy, in alignment with EGT, and supports execution of data communication strategy
Supports product-specific US clinical trial execution
Medical / Scientific contribution to Value Dossiers, compendia and interactions with payers in collaboration with VA&P
Medical input into label and regulatory interactions, in alignment and with deep understanding of global strategy and program clinical trial data
Engagement strategy and execution with medical experts, professional societies, patient groups and other key stakeholders
Participates in advocacy from a medical perspective in partnership with Commercial, Government Affairs and GRAAS policy
Builds Amgens reputation as a science-based and patient-focused reliable partner
Ensures human subject safety for marketed product in cooperation and effective partnership with responsible functions (e.g., GRAAS, Global Development)
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Medical Asset Lead professional we seek is a passionate leader with these qualifications.
MD or PhD
2-4 years of medical affairs experiences or clinical development experience; 1-2 of which should be from a pharmaceutical or biotechnology company
MD plus accredited fellowship in respective product, board certified or eligible
PhD with extensive in the cardiometabolic space
Clinical research/medical affairs experience inbiopharmaceutical or CRO industry
Familiarity with US health care compliance considerations
Experience with opinion leader interactions, publications planning, data generation activities, and promotional review
Experience with integrated delivery networks, accountable care organizations, and payers
Broad and formal leadership experience
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
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.careers.amgen.com
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.
Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to 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.Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.