Feb 03, 2019

Amgen - Clinical Research Medical Director – Oncology (Blinatumomab/Leukemia)

  • Amgen
  • Thousand Oaks, CA, USA
Full time Pharmaceutical

Job Description

This role is responsible for:

• Supporting the development, execution and communication of the global scientific/medical evidence plan

• Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program

• Supporting the development of key scientific external relationships with opinion leaders

• Participating and providing 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

Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by GDL

Identify new clinical research opportunities Support in-licensing and out-licensing activities and partner relationships

Support product lifecycle management for new indications as directed by Global Development Leader

Provide clinical content input to:

• Regulatory interactions and documents

• Safety interactions and documents

• Materials to be used in Scientific Affairs

• Materials to be used by the Commercial Organization

Basic Qualifications:

MD/DO AND 2 years of clinical research experience and/or basic science research

Preferred Qualifications

• MD plus accredited residency in relevant sub-specialty, board certified or equivalent

• 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 company)

Knowledge:

• 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

• Sound scientific and clinical judgment

• Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements

• Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication

• Demonstrated ability as a medical expert in a complex matrix environment

• History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues


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