Kathleen Windle
Associate Director, Clinical Trial Supplies (Rare Disease) at Amgen
- Role
- Associate Director, Clinical Trial Supplies (Rare Disease) at Amgen
- Location
- Rockville, MD, US
- LinkedIn followers
- 500 followers
About Kathleen Windle
I am a realist, an optimist, and a proactive facilitator. I enjoy my career and the challenges it provides me. Change for improvement and growth are what I strive for always. Many people, departments, and processes are necessary to begin, maintain, and complete clinical trials. I thrive amid all those people and departments, ensuring all are communicating to provide a fluid supply chain of quality and continuity, right up to the end-user, the subject.
Experience
Associate Director, Clinical Trial Supplies (Rare Disease)
Oct 2023 — Present · Rockville, MD, US
Education
University of Maryland
BS in Medical REsearch and Technology
1992 — 1994
UMAB
Bachelor of Science (BSc), 1996
1994 — 1996
Skills
- Biologics
- Validation
- Infectious Diseases
- Medical Affairs
- Medical Writing
- Biostatistics
- Pharmaceutical Industry
- Sop
- Fda
- Regulatory Affairs
- Lifesciences
- Regulatory Submissions
- Good Clinical Practice (Gcp)
- Clinical Operations
- 21 Cfr Part 11
- Life Sciences
- CRO
- Cdisc
- Clinical Trial Supply Chain
- Clinical Monitoring
- Technology Transfer
- Biomarkers
- Ind
- Ich-Gcp
- Oncology Clinical Research
- Drug Development
- Gcp
- Biopharmaceuticals
- Clinical Development
- Drug Discovery
- Clinical Data Management
- Oracle Clinical
- Glp
- Edc
- Therapeutic Areas
- Ctms
- Rheumatology
- Clinical Study Design
- Vaccines
- Oncology
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