Clinical Research Medical Director, Inflammation

  • Company: Amgen
  • Posted: January 27, 2017
  • Reference ID: R-33229
Amgen remains focused on inflammation and making strides in the development of molecules for variety of inflammatory conditions.
The Inflammation/Oncology TA is seeking a physician for their Inflammation Clinical Development Team, reporting to the global development leader (GDL). Key responsibilities will include:
- Supporting the development, execution and communication of the global scientific 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 medical 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, as delegated by the GDL
- May 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 inflammation or oncology, board certified or equivalent
- Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO)
- Five (5) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities
- In-depth understanding of clinical development and concepts of clinical research and clinical trial design, including biostatistics
- 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.

Share this Job