Thousand Oaks, CA, United States
Healthcare, Manager, Clinical Research, Pharmaceutical, Research, Biotech
Amgen is seeking a Clinical Research Medical Director to join its global heart failure clinical development program, which includes approved and multiple investigational therapies across all phases of development. This position is located in Thousand Oaks, California.KEY ACTIVITIESProvide clinical and scientific leadership and oversight for generation of scientific evidence, especially the development and execution of clinical trials across all phases of developmentInterpret clinical trial data to author clinical study reports, publications and regulatory documentsDevelop relationships and collaborate with academic partners and other key opinion leadersGive scientific presentations at advisory boards, key scientific meetings and external committee meetingsGive clinical and scientific guidance and direction to:Interactions with regulatory agenciesGlobal medical scientific platform and other scientific communicationsSafety assessmentsClinical observational research projectsHealth economics research and value and access strategyIn-licensing and out-licensing activities and partner relationshipsIdentify new clinical research opportunities#LI-POSTMD01Basic QualificationsMD or DO degree from an accredited medical schoolAND2 or more years of clinical research experience and\/or basic science researchPreferred Qualifications Accredited fellowship in Cardiology, board certified or equivalent5 years of clinical research experience and\/or basic science research combined with clinical teaching and patient care activitiesAbility to effectively present ideas and document complex medical\/clinical concepts in both written and oral communicationDeep understanding of the scientific method and practical clinical applicationsFamiliarity with clinical research and clinical trial design, including biostatisticsClinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO)Knowledge of Good Clinical Practice (GCP), FDA and EMEA\/CHMP regulations and guidelines, and applicable international regulatory requirementsDemonstrated ability as a medical expert in a complex matrix environmentHistory of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issuesOur recruitment strategy includes fostering diverse points of view \u2013 helping to drive innovation and creativity.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\u2019s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world\u2019s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.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.
Website : http://www.amgen.com
Amgen discovers, develops, manufactures, and delivers innovative human therapeutics. A leader in biotechnology since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease, and other serious illnesses.