Medical Director, US Medical, Erenumab - Thousand Oaks, CA | Biospace
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Medical Director, US Medical, Erenumab

Amgen

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Location:
Thousand Oaks, CA
Posted Date:
4/27/2017
Position Type:
Full time
Job Code:
R-36224
Salary:
Required Education:
Medical Doctor
Areas of Expertise Desired:

Job Description

Reporting to the Therapeutic Area Head (Neuroscience), US Medical Organization, the US Medical Director helps to develop and implements US Medical strategies, with a primary focus on tactical execution for the product.

The Medical Director's responsibilities include:
· Successful execution of key aspects of the Medical program for a novel product in development for migraine prevention
· Contribute to the development, execution and communication of the US Medical Team (USMT) product plan
· Serve as a key Medical point of contact in the launch process to ensure alignment between medical and brand activities; partner closely with the US Commercial team to ensure accuracy and appropriateness of promotional content development and ensure accuracy and appropriateness in promotional review
· 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)
· Helping to 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
· Contribute to the design and execution of 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, RML 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
· Contribute to and/or lead execution of medical Advisory Board Meetings
· Provide interpretation of clinical study data
· Participate in review of US Non-Amgen Sponsored Clinical Research (NASCR) proposals

Requirements

Basic Qualifications
· MD, board certified or board eligible in Neurology or related discipline
· 3-5+ years of industry experience, with substantive experience in key aspects of a product (pre-approval or in-line) Medical program

Preferred Qualifications
· Experience in product launch in Neurology or related field (e.g. pain management)
· Accredited fellowship in Neurology, preferably in Headache but other relevant experience will be considered
· 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 payors
· Experience in a matrix environment