Clinical Research Medical Director, Rheumatology Rare Disease
at Amgen
Washington, DC 20004, USA -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 20 Nov, 2024 | USD 318868 Annual | 22 Aug, 2024 | 2 year(s) or above | Rheumatology,Regulatory Interactions,Relationship Development,Licensing,Nephrology,Key Opinion Leaders,Global Strategy,Commercialization,Advisory Boards,Scientific Presentation,Regulatory Submissions,Materials,Clinical Development,Collaboration | No | No |
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Description:
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
Clinical Research Medical Director
BASIC QUALIFICATIONS:
MD or DO degree from an accredited medical school
PREFERRED QUALIFICATIONS:
- MD with strong and versatile clinical development experience in Rheumatology or Nephrology, and accreditation in relevant sub-specialty
- Three (3) or more years of clinical development experience and/or basic science research combined with clinical teaching and patient care activities.
- Clinical development experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)
- Experience in development lifecycle management to include development strategy creation for large programs from early development, through late development and commercialization.
- Involved in filing activities as part of the moving the program through the development lifecycle.
- Key relationship development and collaboration with the expansive commercial and medical teams internal and external partners and key opinion leaders.
- Previous management experience of clinical development professionals
Responsibilities:
Let’s do this. Let’s change the world. In this vital role you will serve as clinical expert to provide clinical/scientific knowledge into the development, delivery and communication of the global scientific/medical evidence plan for the indication(s).
- Provide oversight of clinical development with input on global strategy
- Support cross-functional and global collaborations to integrate broad medical, regulatory, safety, scientific, and commercial access, and value input into the development program(s)
- Participate and provide clinical input into safety and regulatory interactions.
- Interpret and communicate clinical trial data.
- Author/review 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 Global Development Lead.
- 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 Lead
- Provide clinical content input to materials to be used in Scientific Affairs as well as the Commercial Organization
- This is a potential managerial role, successful prior experience seeking and developing talent is a plus.
REQUIREMENT SUMMARY
Min:2.0Max:7.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
Graduate
Proficient
1
Washington, DC 20004, USA