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For your reference, we have included the original job posting below.
Clinical Research Medical Director - Bone Therapeutic Area
Job Number:
41708842
Company Name:
Amgen
Job Location:
Thousand Oaks, CA US
Job Categories:
Clerical & Administrative Research
Clinical Research Medical Director - Bone Therapeutic Area
The Clinical Research Medical Director (Bone Therapeutic Area) 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
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
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 relevant sub-specialty, 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 with endocrinology, rheumatology, or internal medicine background.
