The US Medical Organization, Medical Director, Oncology, US Medical Leader (USML) is the single point of accountability and matrix leader for US Medical strategies, including US launch and life cycle management.
The USML is responsible for:
Leading the development, execution and communication of the US Medical Team (USMT) plan.
Collaborating with the US Brand Team in the brand/launch planning process to ensure alignment between medical and brand activities
Data generation in the US (including Ph4, HE, Observational, Comparative Effectiveness, and Non-Amgen Sponsored Clinical Research (NASCR)) in partnership with Development Operations, Center for Observational Research and Global Health Economics in support of global development and regional strategies
Partnering with the Amgen Therapeutic Area (TA) field-based, Regional Medical Liaisons (RMLs) and HOPE (Health Outcomes and Payer) RML teams to develop and maintain relationships with external clinical community, including interactions with opinion leaders, payers and medical societies for scientific exchange
Developing 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 (eg, protocol, CSR, manuscript)
Ensuring consistency of clinical content and scientific messages across publications and materials
Reviewing/funding US IME, donation and sponsorship requests, aligned with global strategy
Budgeting and forecast accuracy within area of responsibility
Coaching, mentoring and developing team members
Provide interpretation of clinical study data
two (2) + years of clinical research experience and/or basic science research in Oncology or significant interest in Oncology
MD plus accredited fellowship in Oncology, board certified or board eligible
Five (5) + years of clinical research experience and/or basic science combined with clinical teaching and patient care activities
Clinical research/medical affairs experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO) that includes collaborations with integrated delivery networks, accountable care organizations, and/or payers
Familiarity with FDA organization, guidelines, and practices
Knowledge of Good Clinical Practices (GCP), US regulations and guidelines, and applicable US regulatory requirements
History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues
Knowledge of pharmaceutical product development, product lifecycle and commercialization process with advanced understanding of other functions; including, but not limited to, Clinical Operations, Commercial, Regulatory, and Medical Affairs
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.
A little about us:
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