Amgen

Medical Director, Medical Affairs, US Medical Leader - Acute Lymphocytic Leukemia/Lymphoma

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Jul 12, 2019
Ref
R-80000
Required Education
Masters Degree/MBA
Position Type
Full time
The US Medical Organization, Medical Director, Oncology, US Medical Leader (USML) for acute lymphocytic leukemia (ALL) and lymphoma 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
  • 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
  • Providing US-focused medical input into global Development strategy, study design and deliverables (e.g., protocol, CSR, manuscript)
  • Ensuring consistency of clinical content and scientific messages across publications and materials
  • Budgeting and forecast accuracy within area of responsibility
  • Coaching, mentoring and developing team members
  • Provide interpretation of clinical study data


Basic Qualifications

MD/DO degree from an accredited medical school OR PhD OR PharmD

AND

2 years of Medical Affairs experience in Hematology-Oncology

Preferred Qualifications
  • MD plus accredited fellowship in Oncology, board certified or board eligible
  • 5+ years Medical affairs experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO) that includes collaborations with integrated delivery networks, accountable care organizations, and/or payers
  • Clinical and disease knowledge base in acute leukemia
  • 2+ years of clinical research experience and/or basic science combined with clinical teaching and patient care activities
  • 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 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.

MD01

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