Auto req 13870BR
Job Posting Title Clinical Research Medical Director - Oncology - Xgeva
Career Category Clinical Development
Employee Subgroup Salaried FT
Country (State/Region) United States - California
Location (City) Thousand Oaks
Amgen Job Description This 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 relevant sub-specialty, board certified or equivalent
- Experience in GU Oncology
- 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)
- prior oncology clinical research / experience
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
