Clinical Research Medical Director - Biosimilars (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 - BiosimilarsLive
What you will do
Lets do this. Lets change the world. In this vital role you will serve as a medical expert for the development of biologics/biosimilar products at each stage of its clinical development in alignment with the Global Development Lead.
Biosimilars are an important development for Amgen and for patients globally. The opportunity to serve patients with greater access to critical therapies furthers the Amgen mission to serve patients. Quality biosimilar development requires a new paradigm, integrating all the science and experience at Amgen of developing biologics as well as our quality manufacturing capabilities while creatively and rapidly executing a streamlined and efficient data generation program to demonstrate similarity to the original product.
The Clinical Research Medical Director (CRMD) is an integral cross-functional partner with the Operations, Regulatory Affairs, Clinical Development Operations, Biostatistical, Safety, Scientific Affairs, and other groups.This role is 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
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 clinical study reports, publications and regulatory submissions
Develop key opinion leaders and make scientific presentations at advisory boards, key scientific meetings and external committee meetings as delegated by Global Development Leader (GDL) Support new clinical research opportunities
Support in-licensing and out-licensing activities and partner relationships
Support product lifecycle management as directed by GDL
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
Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements
Ability to optimally present ideas and detail complex medical/clinical concepts in both written and oral communications
Demonstrated ability as a medical expert in a complex matrix environment
History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues
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 professional we seek is a dedicated leader with these qualifications.
MD/DO (or equivalent) and 2 years of clinical research experience and/or basic science research
MD plus completion of an accredited residency with experience in oncology/hematology or related disease areas
5+ years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities
Drug development experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)
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.
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.