Clinical Research Medical Director - Oncology - 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.Clinical Research Medical Director - OncologyLive
What you will do
Lets do this. Lets change the world. Today, Amgen is advancing the largest early Oncology pipeline in our history spanning several innovative technology platforms Bispecific T Cell Engagers (BiTEs), CAR Ts, Bispecific Antibodies, Oncolytic Viruses, Neoantigen Vaccine and Small Molecules across many targets and more than a dozen tumor types. In this vital role you will:
- Contribute to the development of overall program clinical development strategy, evidence generation plan (EGP), and execution of program level activities
- Lead the design and development of clinical study protocols
- Serve as a member of the Clinical Study Team - Leadership Team (CST-LT) to provide oversight and execution of clinical trials.
- Provide medical and scientific leadership for design of clinical studies and contribute to trial execution from Phase 2 through life-cycle management
- Collaborate with internal stakeholders and external scientific community such as investigators, key opinion leaders (KOL), etc., as it relates to clinical study design, execution, and results communication.
- Lead development of and co-author clinical study protocol and related documents for example Key Design Elements (KDE), Clinical Study Reports (CSR), and clinical scientific publications (CSP).
- Monitor, analyze, and interpret clinical study data as a Global Development Representative
- Identify and evaluate new clinical research opportunities
- Provide clinical contribution to regulatory submissions, safety documents, and reimbursement related documents
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The qualified] professional we seek is a leader with these qualifications.Basic Qualifications
Doctorate or MD and 4-5 years of clinical research experience and/or completion of an accredited medical or surgical residencyOr
Clinical experience in either an accredited academic setting or private practice (including hospital based) setting Medical Doctor or Ph.D.Preferred Qualifications
- MD or Ph.D plus accredited residency in relevant sub-specialty, board certified or equivalent
- Eight (8) or more 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)
- Previous management experience
- In-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trials
- Medical knowledge in the relevant therapeutic area
- Understanding of regulatory agency organization, guidelines, and practices and ability to negotiate with these groups
- Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
- Understanding of new drug commercialization and business practices
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
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.
careers.amgen.comEqual 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.Amgen requires all staff in the United States and Puerto Rico 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.