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.

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

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



Basic Qualifications

MD or DO degree from an accredited medical school

Preferred Qualifications

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.