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For your reference, we have included the original job posting below.
Clinical Research Medical Director - Neuroscience
Job Number:
43654677
Company Name:
Amgen
Job Location:
Thousand Oaks, CA US
Job Categories:
Clerical & Administrative Research
Clinical Research Medical Director - Neuroscience
The Clinical Research Medical Director (Neuroscience Therapeutic Area) will be based at Amgen's Thousand Oaks, California headquarters and will report to the Executive Medical Director Global Development, Neuroscience Therapeutic Area.
The Clinical Research Medical Director 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 - Two (2) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities
Preferred Qualifications - MD plus accredited residency in Psychiatry or Neurology, 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) in the areas of neurology or psychiatry.
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
