Clinical Research Medical Director - Inflammation (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 - InflammationLive
What you will do
Lets do this. Lets change the world. In this vital role you will lead the global Phase 2/3 inflammation program for AMG 157 Tezepelumab, anti-TSLP. The asset is being investigated as a treatment for multiple indications, including asthma, atopic dermatitis, COPD, chronic spontaneous urticaria, and chronic rhinosinusitis with nasal polyps. Tezepelumab is being developed in collaboration with AstraZeneca.
The Clinical Research Medical Director will have an opportunity to shape the growing Inflammation Therapeutic Area and will report directly to the Global Development Lead for the program. The position is located in Thousand Oaks, California; a remote work arrangement will be considered. Responsibilities will include:
- 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
- Support cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program
- Participate and provide clinical input into safety and regulatory interactions
- Interpret and communicate 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 as well as 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 leader with these qualifications.Basic Qualifications
- MD or DO degree from an accredited medical school AND
- Completion of an accredited medical or surgical residency OR
- Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
- Strong and versatile clinical development experience in inflammation, and accreditation in relevant sub-specialty (i.e. allergy/immunology, dermatology)
- 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
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.
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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.