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Medical Director, Clinical Development, Bone TA Thousand Oaks United States,  

Amgen (company)

Posted on : 26 August 2017

Project Description

The Bone, Nephrology and Inflammation TA is seeking a Clinical Research Medical Team member 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

Preferred Qualifications
- MD plus accredited residency in relevant sub-specialty (endocrinology, rheumatology, or internal medicine), 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 the endocrinology and/or rheumatology area.

- 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.


US, California, Thousand Oaks

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