Frank Albers
Senior Global Medical Lead at Avillion Life Sciences
- Role
- Senior Global Medical Lead at Avillion Life Sciences
- Location
- Chapel Hill, NC, US
- LinkedIn followers
- 500 followers
About Frank Albers
I am an MD with a PhD in transplantation immunology and over 20 years experience in the pharmaceutical industry with a patient focused mindset in roles of increasing responsibility in the areas of Respiratory, Allergy and Immuno-inflammation Clinical Development and Medical Affairs from a global, strategic and an operational, country perspective. I offer comprehensive medical expertise and background in planning and implementing globally aligned phase II-IV clinical development and life cycle management strategies and plans, including clinical trial and real-world study designs, analyzing and interpreting clinical trial results, drug safety assessments (DSURs), developing and executing a comprehensive publication strategy as well as supporting pre- and post-approval marketing plans. Hands-on involvement with 3 NDA/BLA preparations and submission reviews with active and supportive participation in 3 FDA Pulmonary-Allergy Drugs Advisory Committees (PADAC).
Experience
Senior Global Medical Lead
Jun 2019 — Present
Medical Lead accountable for overseeing the Clinical and Medical aspects of the PT027 (budesonide/albuterol MDI) clinical development program of 3 Phase 3 studies including Medical Monitoring and Pharmacovigilance, Study Governance and Steering Committee and medical support of study conduct and reporting as well as FDA filing leading to successful approval of Airsupra® in January 2023.
Education
Gymnasium Kiel-Wellingdort
Abitur, Biology, Maths
1979 — 1989
Kiel University
Doctorate (PhD), Transplantation Immunology
1996 — 2002
Kiel University
MD, Human Medicine
1991 — 1999
Skills
- Data Analysis
- Clinical Study Design
- Clinical Trials
- Great People Skills
- Respiratory
- Clinical Development
- Health Economics
- CRO
- Regulatory Affairs
- Copd
- Clinical Research
- Advisory Boards
- Pharmaceuticals
- Biologics
- Data Interpretation
- Cross-Functional Team Leadership
- Outcomes Research
- Immunology
- Allergy
- Drug Development
- Medical Research
- Medical
- Ms Office Suite
- Data Presentation
- Team Leadership
- Dry Powder Inhalers
- Strategic Leadership
- Microsoft Office
- Pharmacovigilance
- Project Management
- Medical Writing
- U.s. Food and Drug Administration (Fda)
- Medicine
- Medical Affairs
- Regulatory Submissions
- Team Management
- Pharmaceutical Industry
- Fda
- Drug Safety
- Respiration
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