David Mariano, PharmD
David Mariano, PharmD
CEO, US Inc.
Dave has served over 20 years in the pharmaceutical industry with experience in NDA/BLA submissions and drug launches, including rare disease, in immunology and infectious diseases.
During Dave’s professional career, he has filled positions of increasing responsibilities in Drug Development, specifically in Pharmacovigilance, and in Medical Affairs.
His most recent position in 2023 was Vice President of Medical Affairs at Nabriva Pharmaceuticals.
Dave has a broad knowledge of the industry establishing internal departments and functions, developing high-performance teams, and facilitating the planning and development of strategic initiatives in senior leadership roles.
He has served as a key member on several multidisciplinary meetings including Safety Monitoring Committee, Compliance Committee, Commercial Planning Committee, and Business Development.
Harald Wagner
Harald Wagner
Director of Clinical Operations
Harald has a scientific background in Pharmaceutical Technology and more than twenty-five years of experience in drug development and clinical research including global, large-scale, long-term safety and efficacy programs, planning and documentation, site selection, initiation, monitoring, organization of investigator meetings, follow-up of patients in long-term projects, selection, qualification and management of vendors, quality assurance and quality control and medical writing.
Harald has extensive experience in the set-up and maintenance of training plans, including implementation of various clinical systems, e.g. DMS, e-learning tools, ePRO, eTMF, CTMS, capacity planning tools and project management tools. He also has experience with project budget planning and presentation to clients, and department management of a 100 head-count Clinical Research team.
Dr. Marianne Diers-Fenger
Dr. Marianne Diers-Fenger
Clinical Operations Manager and Associate Director of Pharmacovigilance and Clinical Safety
Marianne has a PhD in Neurology and more than 15 years of experience in Clinical Research, including Management of large-scale, long-term clinical research programs with a strong focus on patient retention and patient safety. Her experience includes Clinical Trial Monitoring, Project Management but also Line Management and Project Supervision.
Marianne is an Associate Director of AMS PV/CS department and is coordinating the interaction between Clinical Operations and Clinical Safety/PV in AMS, globally.
Kathryn Hutchinson
Kathryn Hutchinson
Managing Director of AMS UK, Director of Regulatory Affairs
Kathryn has over 25 years of experience in clinical drug development in all phases of development from Phase I-IV. She regularly consults on drug development and regulatory strategies and implementation across Europe and Eastern Europe.
Kathryn has a specialty and expertise in managing oncology, hematology and rare disease clinical studies including managing strong KOL and site relationships throughout the EU.
Dr. Gerlinde Jänel
Dr. Gerlinde Jänel
Director of Medical Sciences
Gerlinde was awarded her PhD in molecular biology (cancer research) from the University of Erlangen-Nürnberg in 1984. During her years in academia, she gained extensive scientific experience in cancer research (University of Erlangen, Fred Hutchinson Cancer Research Center in Seattle), AIDS research (Harvard Medical School in Boston, University of Erlangen), and Public Health research (Institute for Public Health and Health Economics, University of Augsburg).
During Gerlinde’s professional career, she has repeatedly filled the position of a Senior Manager in clinical research, both in the pharmaceutical industry and in the CRO business. She worked in the European Headquarters of Astellas Pharma GmbH gaining profound experience in Medical Drug Development. Gerlinde offers an in-depth knowledge of the global drug development process, from protocol development to study reports and from strategic planning, coordination and preparation of clinical documents for European submissions. Gerlinde has held the position of Director Medical Science at AMS since October 2008, where she developed the business field of value dossiers and market access. Currently, the Medical Science Group consists of 42 medical writers and 19 biostatisticians.
Rolf Tiemann
Rolf Tiemann
Director of Biostatistics and Data Management
Mr. Tiemann has been a statistician with more than 20 years proven leadership experience in global pharmaceutical companies and CROs specifically with an expertise in pharmaceutical Reseasrch and Development in Biostatistics and Data Management. Mr. Tiemann has had functional responsibility in process management with efficiency improvements to shorten submissions to regulatory authorities, has been successful in leading global departments of data management and biostatistics.