Amgen Clinical Research Medical Director - Oncology - US Remote in Thousand Oaks, California
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
Clinical Research Medical Director - Oncology
What you will do
Let’s do this! Let’s change the world. In this vital role you will be 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
Working collaboratively with multifunctional teams, bringing your scientific acumen and insights to the workstream
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
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The medical director we seek is a professional with these qualifications.
Doctorate or MD and 4 years of clinical research experience Or
Master’s degree and 7 years clinical research experience Or
Bachelor’s degree and 9 years of clinical research experience
MD plus accredited residency in Hematology Oncology, board certified or equivalent
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 company)
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 outstanding judgment and a balanced, realistic understanding of issues
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
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.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.