Clinical Research Sr Medical Scientist, Oncology-GI (Open to remote)
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If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.Clinical Research Sr Medical ScientistLive
What you will do
Amgens Global Development group is looking for a Senior Medical Scientist (SMS) to support the bemarituzumab program.
Bemarituzumab (anti-FGFR2b) is a potential first-in-class investigational targeted antibody that is designed to block fibroblast growth factors (FGFs) from binding and activating FGFR2b, inhibiting several downstream pro-tumor signaling pathways and potentially slowing cancer progression. Bemarituzumab is being developed in gastric and GEJ cancer as a targeted therapy for tumors that overexpress FGFR2b. The company is also evaluating the potential for bemarituzumab in other cancers that overexpress FGFR2b.
Join our team as we enter an exciting stage of drug development for bemarituzumab!
This SMS will be responsible for supporting the development, execution and communication of global evidence generation activities. These experts represent Global Development internally and externally, contributing intellectual insight into experimental design and data analysis. They provide subject matter expertise in clinical oncology and trial science as well as the biology and treatment of cancer.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 study documents, CSRs, publications and regulatory submissions
- Present information internally and externally
- Anticipating and proactively managing problems across a broad spectrum of cross-functional teams;
- Coordinate clinical approaches to operational issues that arise during clinical trial execution
- Serve as an internal expert in oncology
- Provide guidance and assistance in the identification and management of oncology clinical trial collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects
- Scientific presentation at advisory boards, key scientific meetings and external committee meetings
What we expect of youBasic Qualifications
- MD/ DO degree from an accredited medical school or PhD in oncology-related subject
- 2+ years of clinical research experience in academia or industry, specifically within solid tumors
- Subspecialty board eligibility/certification in Internal Medicine, Oncology and/or Hematology
- Prior experience authoring, monitoring, analyzing, and presenting oncology clinical trials
- Effective presentation and communication abilities (both written and oral)
- Ability to anticipate problems and find creative solutions
- 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
- Experience functioning as a medical expert in a complex matrixed environment
- Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements
- Experience authoring clinical sections of CTAs/INDs
We provide the opportunities, resources and rewards of a global enterprise, with the verve of an early biotechnology pioneer.
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 peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.Thrive
What you can expect of us
As we work to develop treatments that take care of others, so we 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
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
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Join UsIf 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.