Clinical Research Medical Director – Neuroscience

  • Company: Amgen
  • Posted: January 12, 2017
  • Reference ID: R-23210
The Neuroscience Therapeutic Area is seeking a Clinical Research Medical Director for a global, high priority Phase 3 neuroscience program in Alzheimer's disease prevention. This role will have an opportunity to shape the growing Neuroscience Therapeutic Area and will report directly to the VP, Neuroscience.
This position will be located in Thousand Oaks, California and will include the following:
• Serve as the clinical lead for Amgen in a 50-50 partnered program.
• In collaboration with the partner, develop the global development strategy for a novel, unprecedented indication for the prevention of AD
• Support the development, execution and communication of the global scientific/medical evidence plan
• Support cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program
• Support the development of key scientific external relationships with opinion leaders
• Participate and provide clinical input into safety and regulatory interactions
• Provide clinical/scientific input during the development and execution of clinical trials, including key observational studies
• Represent Amgen development in interactions with partners
• Interpret clinical trial data
• Participate in safety assessments
• Participate in interactions with regulatory agencies
• Author 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
o Provide clinical content input to:
o Regulatory interactions and documents
o Safety interactions and documents
o Materials to be used in Scientific Affairs
o Materials to be used by the Commercial Organization
• MD
• Three (3) or more years of clinical research experience
• MD plus accredited residency in relevant sub-specialty
• Board certified or equivalent
• Strong background in neurodegeneration/neurobehavior
• 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
• Experience on partnered programs
• Strong background in neurodegenerative diseases with expertise in AD highly preferred
• Experience and knowledge in designing, conducting and analyzing Phase 2 and/or 3 clinical trials in AD
• Familiarity with FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements, particularly for AD
• 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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