Clinical Research Senior Medical Scientist - Oncology (Kyprolis)

Amgen's Clinical Development organization is focused on the global clinical evidence generation activities for its late stage drug candidates and the ongoing scientific support for its marketed drug products.

Join our team as we enter an era of oncology drug development that will usher in new wave of advances that promise to transform cancer care.

This Clinical Research Sr Medical Scientist will be responsible for supporting the development, execution and communication of the global scientific/medical evidence plan. This role works with cross-functional and global collaborations to integrate broad medical and scientific input into the development program. Additionally, the Sr Medical Scientist supports the development of key scientific external relationships with opinion leaders and participates and provides clinical input into safety and regulatory interactions.

Key Activities:

• Provide clinical/scientific input during the development and execution of clinical trials
• Interpret clinical trial data
• Participate in safety assessments
• Participate in interactions with regulatory agencies
• Author CSRs, publications and regulatory submissions
• Scientific presentation at advisory boards, key scientific meetings and external committee meetings
• Identify new clinical research opportunities
• Active participation with in-licensing and out-licensing activities and partner relationships
• Support product lifecycle management for new indications

Basic Qualifications

MD or DO degree from an accredited medical school

Preferred Qualifications

• 2+ years of Medical Scientist experience
• Accredited residency in oncology, board certified or equivalent
• Experience in Hematology
• 5+ years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities
• Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO)
• Oncology clinical research experience
• In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale
• Familiarity with concepts of clinical research and clinical trial design, including biostatistics
• Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements
• Experience effectively presenting ideas and documenting complex medical/clinical concepts in both written and oral communication to a broad variety of audiences

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.

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