MANAGEMENT

Knut T. Smerud, MSc, CEO/executive chairman/founder&owner

Knut Smerud is a biochemist by training, graduated from the University of Oslo in 1989. He is further a business candidate from the Norwegian school of management, 2004. He is continuing his academic career with a PhD project at the University of Oslo (Norway) related to clinical trials in the prevention of long-term complications in kidney transplant recipients. His professional career involves medical director roles in the Norwegian subsidiaries of Lilly and Bayer. In 1993 he started the clinical CRO, Smerud Medical Research Group, which has since grown to 30 employees in 4 Nordic countries as well as in the UK, Poland, Austria and Germany. Smerud is also the founder of a small venture capital firm (Scandinavian Biotech Venture AS), and a clinical research clinic (Forskningsklinikken AS).

 He has served as a member in several Scientific Advisory Boards, for domestic and international biotech companies, and has been a member of several international study steering committees. Knutwas elected the first chairman of the board of the Norwegian Association for CROs, an organization he was one of the co-founders of in 2005, and has since 2009 represented NCROF in the European Foundation of CROs. Between 2006 and 2014, Knut served as a member of the board of a Norwegian Centre for Innovation, the sfi2, which was a consortium for applied medical statistics. Since 2008, he was elected as the chairman of the Norwegian Society for Clinical Trials (FKLUT). Since 2013, he has been a board member of Swedish medical device company Alimenta Medical AB. In 2018, he was elected as chairman of the board for biotech start-up company iNanod AS, and as board member in biotech company Bionor Immuno AS.

 During his career, he has managed approximately 175 clinical trials, conducted about 500 monitoring visits throughout Europe, and is the author of about 100 clinical study protocols and 50 clinical study reports. His publication list includes some 20+ published manuscripts and several pending publications, and he is a reviewer for the British Medical Journal and Transplant International. He is frequently invited as a lecturer to various conferences on clinical trial management and clinical research in general.

 Knut has a vast experience in writing public and commercial research grant applications. In recent years, he has initiated and directed several clinical research consortia in the EU, all aiming to develop new drugs. He has designed and authored grant applications which have raised about 40 million Euros in public grants for biotech clinical trials.

 

Charlotte R. Kleiveland, PhD, COO.

Dr Charlotte Kleiveland is a biochemist by training, graduated from the University of Oslo 1999. Further, she obtained her Ph.D. in inflammation and mesenchymal stem cell biology at the University of Oslo in 2008. She started her career in the CRO industry as a clinical research associate at SMERUD from 2001-2006, before going back to academia, completing her PhD and thereafter continued with post doc positions combined with an associate professorship at the Norwegian University of Life Sciences (NMBU), Ås, Norway. Since January 2015, Charlotte returned to SMERUD in a position as Director of Clinical Operations and lately as Chief Operating Officer at Smerud Medical Research International. She is also acting Country Manager for our Norway, Sweden and Denmark subsidiaries. During her carrier she has managed 30+ clinical trials (including several first in human trials), conducted 150 monitoring visits throughout Europe, written and contributed to protocols and several clinical study reports. Charlotte has contributed to 25+ peer reviewed scientific publications.

Hilde Kloster Smerud, PhD,  Director of Regulatory Affairs & QA.

Dr  Hilde Kloster Smerud is a pharmacist by training (Oslo/New York, 2000) and earned her PhD in clinical medicine in Uppsala, Sweden with a thesis related to IgA nephritis. She has been employed with SMERUD since 2000, and is currently SMERUD’s QA manager and Acting Director of Regulatory Affairs.

Hans Müller, PhD,  Country Manager Germany.

Dr. Hans Müller has a diploma in chemistry of the university Heidelberg and graduated as PhD in chemistry. He has been working since 1996 in the clinical research business as project manager, head of clinical operations and clinical research scientist. Since 2013 he is heading the German Smerud office located in Mannheim. During the last 25 years he has been responsible for the conduct of more than 85 international (European and global) clinical trials with more than 10.000 patients in about 1.800 sites in various indications in all clinical phases. Within these tasks he has trained external and internal research staff and has prepared scientific and regulatory documents. The current scientific focus is on rare diseases, oncology and ophthalmological indications. He has 10 years experience in the Management (member of the management board) of a Contract Research Organisation, located in 15 European countries and 8 years as manager of the German affiliate of Smerud.

Amanda Knock, PhD,  acting Country Manager UK.

Amanda has a BSc hons in biology and psychology; MSc in Biomedical Sciences; PhD in cell biology, and has over 20 years’ experience within the biotechnology / pharmaceutical and CRO industry. She has held a number of positions including clinical research / clinical outcomes roles, lab-based analytical and research roles, drug discovery / IP support and clinical trials support roles. Amanda has been with Smerud since September 2011 as a Clinical Research Scientist and her current roles and responsibilities include medical writing, regulatory submissions and project finance.