Clinical Research Sr Medical Scientist

  • Company: Amgen
  • Posted: October 06, 2015
  • Reference ID: 34375BR
The Clinical Research Sr. Medical Scientist is responsible for:

- Supporting the design, assessment 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
- Provide clinical/scientific input into, author sections of, and QC study-related
documents (e.g. protocols)
- 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 Degree

Preferred Qualifications

- Accredited residency or fellowship in relevant specialty
- Board certified or eligible or equivalent
- 2+ years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities
- Specialties of interest are endocrinology, rheumatology, orthopaedics or internal medicine.

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