Amgen Clinical Research Senior Medical Scientist - Oncology in Thousand Oaks, California
Amgen's Clinical Development organization is focused on the global clinical evidence generation activities for its late stage drug candidates and the ongoing scientific support for its marketed drug products.
This Clinical Research Sr Medical Scientist will be responsible for supporting the development, execution and communication of the global scientific/medical evidence plan. This role works with cross-functional and global collaborations to integrate broad medical and scientific input into the development program.
Additionally, a Sr Medical Scientist supports the development of key scientific external relationships with opinion leaders and participates and provides clinical input into safety and regulatory interactions.
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
Scientific presentation at advisory boards, key scientific meetings and external committee meetings
Identify new clinical research opportunities
Active participation with in-licensing and out-licensing activities and partner relationships
Support product lifecycle management for new indications
MD or DO degree from an accredited medical school
Accredited residency in oncology, board certified or equivalent
Experience in Hematology
5+ 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)
Oncology clinical research experience
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
Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements
Experience effectively presenting ideas and documenting complex medical/clinical concepts in both written and oral communication to a broad variety of audiences
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.