Amgen Clinical Research Medical Director - Gastrointestinal - AMG 592 in Thousand Oaks, California
The Inflammation Therapeutic Area is seeking a Clinical Research Medical Director to serve as indication lead for global Phase 2B inflammation program AMG 592, an IL 2 mutein. It is being investigated as a treatment for multiple indications, including SLE, GVHD and IBD.
This position is located in Thousand Oaks, California but can be flexible, depending on the situation and will have an opportunity to shape the growing Inflammation Therapeutic Area and will report directly to the Global Development Lead for the AMG 592 program.
Serve as the study/indication lead and provide clinical/scientific knowledge into the development, execution and communication of the global scientific/medical evidence plan for the indication
Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program
Participating and providing clinical input into safety and regulatory interactions
Interpretation and communication of clinical trial data
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:
Materials to be used in Scientific Affairs
Materials to be used by the Commercial Organization
MD or DO degree from an accredited medical school
2 years of clinical development experience in industry
MD with strong and versatile clinical development experience in inflammation, and accreditation in relevant sub-specialty (gastroentrology)
Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes
Experience with developing study concepts for clinical development and clinical trial designs with cross functional input, including biostatistics, observational research and patient reported outcomes in Phase 1,2 and/or 3 clinical trials in inflammation/immunology
Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements
Leadership experience/potential as a medical expert in a complex matrix environment
Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
Strong interpersonal skills and problem-solving abilities while exhibiting superior judgment and a balanced, realistic understanding of issues and resolution path
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 people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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.