Medical Director, US Medical Lead - Aimovig

Employer
Amgen
Location
Thousand Oaks, California
Posted
Jul 25, 2018
Ref
R-59909
Required Education
Bachelors Degree
Position Type
Full time

Reporting to the Therapeutic Area Head (Neuroscience), US Medical Organization, the US Medical Lead develops and implements US Medical strategies, including launch and lifecycle management, and provides strategic and tactical leadership to the US Medical team for the product.

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

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