Medical Director-Medical Affairs/Cardiovascular US - Remote
- Thousand Oaks, CA
- Start date
- Mar 14, 2023
- Clinical, Medical Affairs
- Required Education
- Position Type
- Full time
- Biotech Beach, Best Places to Work
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.
Medical Director - Medical Affairs/CardiovascularLive
What you will do
Lets do this. Lets change the world. In this vital role the Medical Director will support the development and delivery of the medical affairs strategy for Amgens Cardiovascular assets (including evidence generation, medical communication, and external engagement), with a focus in the US and support to Global. While this position is based in Thousand Oaks, California, we are open to a US remote work arrangement.
- Support Medical Affairs strategies by enhancing molecule value proposition, including planning and goal setting, launch support and lifecycle management, in collaboration with Medical Asset Lead and/or Medical TA Head, Product Team/Portfolio Governance and in alignment with Global strategy
- Implementation science and value-based partnership projects expert, Globally reviewing and providing recommendations about new proposals aligned with product 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 Development Operations; 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
- Determine scientific/medical subject matter appropriateness of promotional and medical deliverables (eg, slide decks, publications, educational activities)
- 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)
- 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 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 improvement
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Medical Affairs professional we seek will have these qualifications.
- MD or DO degree from an accredited medical school OR PhD OR PharmD
- 2 years of Medical Affairs and/or related clinical research experience and/or basic Cardiovascular science research
- MD plus accredited fellowship in Cardiovascular area or related medical discipline, board-certified or board eligible
- PhD with extensive experience in the cardiometabolic space
- Clinical and disease knowledge base in cardiovascular disease states
- 2 years of clinical or observational combined with clinical teaching and patient care activities
- 5 years Medical Affairs experience in the biopharmaceutical industry (biotech, pharmaceutical, or CRO) including collaborations with integrated delivery networks, accountable care organizations, and/or payers
- Pharmaceutical product development, product lifecycle and commercialization process knowledge with advanced understanding of other functions; including, Clinical Operations, Commercial, Regulatory, and Medical Affairs
- Experience with stakeholder engagement and interactions (e.g., opinion leaders, advocacy groups, payers)
- Broad and formal leadership experience, including opinion leader interactions
- Familiarity with global regulatory organizations, guidelines, and practices
- Knowledge of Good Clinical Practices (GCP) and global regulations and guidelines
- History of solving problems while exhibiting sound judgment and a balanced, realistic understanding of issues
- Track record of success working with matrixed cross-functional teams
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 annual base salary range for this opportunity in the U.S. is $258,865. - $307,185.
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 plan
- Stock-based long-term incentives
- Award-winning time-off plans and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
for a career that defies imagination
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
If 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 cancers, 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.
We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.
We live the mission.
We win together.
We thrive on continual challenge.
Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.
At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.
Connect with us to explore how you can Win, Live, and Thrive at Amgen.
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