Clinical Research Medical Director, Neuroscience

  • Company: Amgen
  • Posted: January 12, 2017
  • Reference ID: R-22642
The Neuroscience Therapeutic Area is seeking a Clinical Research Medical Director for a global, high priority Phase 3 neuroscience program in migraine prophylaxis, a monoclonal antibody targeting a novel pathway. This role will have an opportunity to shape the growing Neuroscience Therapeutic Area and will report to the Global Development Leader (GDL), who in turn reports to the VP, Neuroscience.
This position will be located in Thousand Oaks, California and will include the following:
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
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
Two (2) or more years of clinical research experience
MD plus accredited residency in relevant sub-specialty (Neurology preferred),
Board certified or equivalent
Five (5) or more 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), preferably in Neuroscience
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
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.

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