Skip to main content

This job has expired

You will need to login before you can apply for a job.

Clinical Research Medical Director - Gastrointestinal - AMG 592

Employer
Amgen
Location
Thousand Oaks, CA, US
Start date
Dec 3, 2020

View more

Discipline
Clinical, Clinical Research
Required Education
Masters Degree/MBA
Position Type
Full time
Hotbed
Biotech Beach, Best Places to Work

Job Details

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.

Responsibilities
  • 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

Basic Qualifications

MD or DO degree from an accredited medical school

AND

2 years of clinical development experience in industry

Preferred Qualifications
  • 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.

MD01

#LI-POST

Join Us

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.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

Facebook  Social Icon - X Logo

Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert