Amgen's Clinical Development organization is hiring a Clinical Research Senior Medical Scientist in Cardiovascular & Metabolic Therapeutic Area in Thousand Oaks, CA.
Key Responsibilities include:
Support the design, assessment, and communication of clinical programs that support the global scientific/medical evidence plan
Support cross-functional and global collaborations to integrate broad /scientific/medical evidence, with commercial input into the development program
Participate in and provide clinical input into safety and regulatory assessments/interactions
Provide clinical/scientific input during development and execution of clinical trials
Provide clinical/scientific input into QC study-related documents (e.g. study concept documents and protocols)
Interpret clinical trials data
Review and provide clinical scientific input to TFL and safety narratives
Review scientific literature
Initiate database analyses to support commercial/clinical objectives
Contribute to the preparation of clinical study reports and regulatory submissions
Participate in interactions with ethic committees and regulatory agencies
Develop relationships with key opinion leaders and make scientific presentations at advisory boards, key scientific meetings and external committee meetings as delegated
Identify new clinical research opportunities
MD/DO degree from an accredited medical school
Accredited fellowship in Cardiology or related to Cardiovascular Discipline, board certified or equivalent 2+ years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities
An understanding of the scientific method and clinical applications based medical, scientific and practical rationale
Familiarity with concepts of clinical research and clinical trial design including biostatistics
Familiarity with regulatory agency organizations, guidelines, and practices
Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
History of solving problems while exhibiting superior judgment and balanced, realistic understanding of issues
We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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.