Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Thousand Oaks

Description

The US Medical Organization, Medical Director, Oncology, US Medical Leader (USML) for Neulasta 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, 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 Medical Communications, US Value & Access, and Global Development
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
MD01

#LI-POST

Basic Qualifications

MD or DO degree from an accredited medical school
AND

2 years of clinical research experience and/or medical affairs experience in Hematology or Oncology

Preferred Qualifications

MD plus accredited fellowship in Hematology-Oncology, board certified or board eligible
5+ 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
Clinical and disease knowledge base in oncology
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
We provide the opportunities, resources and rewards of a global enterprise, with the verve of an early biotechnology pioneer.

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.

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.

About the company

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.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

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