Medical Director Early Development - Solid Tumor (Open to remote)
HOW MIGHT YOU DEFY IMAGINATION?
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.
Medical Director - Early Development/Translational - Hematology/Oncology
What you will do
Lets do this. Lets change the world. The Translational Medicine Group is looking for a strong leader in Hematology/Oncology. In this vital role of Medical Director you will lead early phase clinical development of oncology compounds from first-in-human studies through proof of concept. The Medical Director defines, designs, and executes early phase clinical and translational projects as the initial strategy for drug development. They also serve as clinical project leaders for one or more of Amgens Product Strategy Teams through their role as an Early Development Leader (EDL). This expert will represent Translational Medicine/Early Development internally and externally, contributing intellectual insight into experimental design and data analysis. They will provide subject matter expertise in clinical and translational trial science as well as the biology and treatment of cancer.
The incumbent will have the following responsibilities:
- Serve as an internal clinical expert in translational and clinical oncology.
- Serve as medical monitor for clinical trials and assists in resolving major issues that may affect the studies.
- Present information internally and externally, anticipating and proactively managing problems across a broad spectrum of cross-functional teams.
- Coordinate clinical approaches to operational issues and assign monitoring and safety reporting resources.
- Provide guidance and assistance in the identification and management of oncology phase 1 collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects.
- Ensure appropriate training, recruitment, and development requirements for matrix team resources.
- Will be the primary Translational Medicine contact for basic scientists studying hematologic and solid tumor malignancies as well as for clinical research scientists overseeing later clinical development.
- Evaluate external opportunities for partnering or licensing new oncology assets
This position can be located in either Thousand Oaks, CA (preferred) or San Francisco, CA, or remote based.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek has the following qualifications.
- MD with at least 2 years of clinical research and/or basic science research experience - OR -
- PhD/PharmD with 10 years of clinical research industry experience in Hematology and/or Oncology
- Subspecialty board eligibility/certification in Oncology and/or Hematology
- Strong basic science or clinical research background in academia or industry
- Prior experience authoring, monitoring, analyzing, and presenting oncology clinical trials
- Effective presentation and communication skills (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 including working knowledge of biomarker methods and clinical imaging endpoints
- A record of high quality peer-reviewed publications
- Experience functioning as a medical expert in a complex matrixed environment
- Previous experience in early phase development and/or biomarker work
- Previous experience in late stage oncology clinical trials and regulatory filings
- Demonstrated expertise in conducting translational and/or clinical oncology research.
- Expertise in Spotfire or other data analysis tools
- Knowledge of GCP, EMA, and FDA policies
- Expertise in authoring clinical sections of CTA or INDs
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
Apply now 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.
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your 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 a 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 an accommodation.
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.