Medical Director, US Medical Lead - Aimovig
- Employer
- Amgen
- Location
- Thousand Oaks, CA
- Start date
- Mar 22, 2019
View more
- Discipline
- Clinical, Clinical Research, Medical Affairs, Science/R&D, Neuroscience
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Biotech Beach, Best Places to Work
Job Details
The Medical Director's responsibilities include:
Leadership of the US medical program for Aimovig (erenumab) in migraine prevention
Lead in the development, execution and communication of the US Medical Team (USMT) product plan
Serve as the primary Medical point of contact in the launch planning process to ensure alignment between medical and brand activities
Supporting data generation in the US (including Ph4, HE, Observational, Comparative Effectiveness, and Non-Amgen Sponsored Clinical Research (NASCR)) in partnership with Development Operations, the Center for Observational Research and Global Health Economics
Partnering with the Amgen Therapeutic Area (TA) field-based, Regional Medical Liaisons (RMLs) and HOPE (Health Outcomes and Payer) RML teams to foster and cultivate relationships with the external clinical community, including interactions with opinion leaders, payers and medical societies for scientific exchange
Supporting the execution of the US advocacy plan in partnership with Scientific Affairs, US Value & Access, and Global Development
Providing US-focused medical input into global Development strategy, study design and deliverables (i.e., protocol, CSR, manuscript)
Ensuring consistency of clinical content and scientific messages across publications and materials
Assisting in the review US IME, donation and sponsorship requests, aligned with global strategy
Key Activities:
Provide US-focused medical input to and review of US commercial plans and global strategic documents
Foster and cultivate relationships with US Opinion Leaders and medical/scientific societies
Support the development and execution of product lifecycle management plan in conjunction with US Brand Team and Global Development
Design and execute phase 4 clinical trials and observational research to support clinical and commercial activities in partnership with Development Operations, Center for Observational Research and Global Health Economics
Provide medical input and support for publications, training, Regional Medical Lead support, congress activities and other scientific affairs activities
Provide medical input, review and participate in approval of materials used by scientific affairs or the US commercial organization
Provide medical content expertise for documents and participate in meetings in support of regulatory, safety, health economic and reimbursement interactions in the US
Lead execution of medical Advisory Board Meetings
Provide interpretation of clinical study data
Review US Non-Amgen Sponsored Clinical Research (NASCR) proposals
#LI-POST
MD01
Basic Qualifications
MD or DO degree from an accredited medical school
AND
2 years of medical affairs, clinical research experience and/or basic science research in Neurology
Preferred Qualifications
MD, board certified or board eligible in Neurology or related discipline
5+ years of industry experience, with substantive experience in key aspects of a product (pre-approval or in-line) Medical program
Experience in product launch in Neurology or related field (e.g. pain management)
Accredited fellowship in Neurology, preferably in Headache or relevant area
2+ years of clinical research experience in Neurology or related field (industry or academic)
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 in a matrix environment
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Company
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.
- Website
- http://careers.amgen.com/
- Phone
- 805-447-1000
- Location
-
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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