Knut T Smerud [MSc]
Executive Chairman & Owner
Knut Smerud is a biochemist by training, who graduated from the University of Oslo in 1989. He is further a business candidate from the Norwegian School of Management, 2004. His professional career involves medical director roles in the Norwegian subsidiaries of Lilly and Bayer.
In 1993 he founded the Smerud Medical Research Group, which has since grown to include owned subsidiaries with locally employed staff in the 4 larger Nordic countries as well as in the UK, Poland, Austria, and Germany. Being a serial entrepreneur, Knut is also the founder of a small venture capital firm (Scandinavian Biotech Venture AS), and a clinical research clinic (Forskningsklinikken AS), both of which have later been merged into the SMERUD group, as well as Smerud Legal & Regulatory group, which offers legal representation services to non-EU based biotech companies.
Knut 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. He was 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 Holding AS.
During his career, he has managed approximately 200 clinical trials, conducted about 500 monitoring visits throughout Europe, and is the author of about 150 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, including a consecutive 20+ years as a lecturer at the Uppsala University’s special post-graduate course in clinical drug development.
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 directed the design and authoring of grant applications which have raised more than 20 million Euros in public grants for biotech clinical trials, and co-authored other grants adding an additional 20 m€ in non-dilutive public funding of clinical trials.
Olav Kleiveland
CEO
As the CEO of SMERUD Clinical Research Organization, a leading consultancy guiding biotech and pharmaceutical companies through clinical trials, I'm passionate about success in the life sciences industry.
With over 20 years of experience, I've witnessed innovations in Technology& Services.
My leadership is data-driven, focusing on excellence. I have a global perspective and deep European market knowledge.
My corporate journey began at Pitney Bowes, a global technology company, where I advanced my career through various roles. In 2019, I took the helm at Azolver, leading the management team in transforming a carve-out into the best-driven, best-structured, and most motivated workforce. This transformation played a pivotal role in a successful M&A process, resulting in the sale of the company
My passion is building successful organizations through strategy, dedicated management, and a strong structure. - Maybe change this to include employee autonomy, enabling each employee to reach their potential supported by structure, rpopcess, systems and managment
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 career first-in-human, she has managed 30+ clinical trials (including several first in human trials), conducted 150 monitoring visits throughout Europe, and written and contributed to protocols and several clinical study reports. Charlotte has contributed to 25+ peer-reviewed scientific publications.
Hilde K. Smerud [PhD]
Director Regulatory Affairs & QA
Dr. Hilde Kloster Smerud obtained a Master’s degree in pharmacy from the University of Oslo, Norway, in 2000 and a PhD from the University of Uppsala, Sweden, in 2012 and has been working with SMERUD since 2000.
Hilde has held many positions within the company during these years. Her main competencies is within regulatory affairs activities and quality assurance. She has a broad knowledge of regulatory clinical trial requirements and is involved in the writing of key study documents like the IMPD, IB, protocol, DSUR, CSR, etc. for several clinical trials. Further, she has a lot of experience with local regulatory affairs post-marketing activities after having had the overall local regulatory affairs post-marketing responsibility at Nordic level for several clients.
Whereas SMERUD Norway has a Manufacturing and Importation Authorisation and a Wholesale Distributor Authorisation, Hilde is listed as QP resp. RP on these licenses. She is also a trained Eudravigilance user and is involved in the company’s safety reporting for clinical trials.
As part of the role as QA manager, Hilde is further involved with SOP writing, audits and both internal and external training courses, primarily GCP training courses.
Hans Müller [PhD]
Country Manager Germany
Dr. Hans Müller has a diploma in chemistry of the University Heidelberg and graduated as Ph.D. in chemistry. He has been working since 1996 in the clinical research business as a project manager, head of clinical operations and clinical research scientist.
Since 2013 he has been heading the German Smerud office located in Mannheim. During the last 25 years,with 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.
Prior to joining SMERUD, Hans had 10 years’ experience in the management (and member of the management board) of another Contract Research Organisation, located in 15 European countries now 10 years as manager of the German affiliate of Smerud.
years
Yvonne Peltonen [BSc]
Country Manager Finland
Yvonne Peltonen has a registered nurse and public health nurse degree from the Swedish College of Nursing and a BSc degree in health science from Tampere University. She has been working for SMERUD since 1997 and has over 25 years of experience within the CRO industry in phase I-IV clinical drug and vaccine trials within several therapeutic areas. Yvonne has acted as country manager for Finland since 2002 and has vast experience as senior CRA and local project manager with experience in close to 1000 site visits in the Nordic countries and France. She has 20 years’ experience as a GCP auditor in several projects and has conducted over 50 training courses within GCP for pharma/biotech companies and universities in many countries.
Amanda Knock [PhD]
Acting Country Manager UK
Amanda has a BSc hons in biology and psychology; an MSc in Biomedical Sciences; a PhD in cell biology, and 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.
Maria Domoradzka [PhD]
Country Manager Poland
Maria Domoradzka obtained a Master of Science degree in pharmacy from the Medical University of Lodz, Poland in 1996 and she became a licensed pharmacist in 1998. She also gained a Ph.D.a degree in chemistry and Master of Science degree in management and administration from Technical University in Lodz, Poland in 2001.
Maria has been more than 20 years in the pharmaceutical industry in junior, middle and senior level positions. Previously she had held positions in academics in Poland then shifted to clinical research at IFE at Łódź office, covering Polish sites as CRA. She has worked for both CROs and pharmaceutical companies in Poland. She has been involved in all project phases, which include start-up, project management, on-site and in-house monitoring of phase II, III, and IV clinical trials, conducting feasibility studies, authorization of clinical trials, and other drug regulatory affairs. Maria has been involved in the management and oversight of the studies on a local level at Biogen, mainly in neurology as well as on a global level across several countries, including Sweden, Denmark, Germany, Italy, Turkey, and South Korea at Navitas Life Sciences.
As Country Manager at Smerud Poland since 2005, she is also responsible for clinical research staff training and plays a key role in the local recruitment process and staff. Her main therapeutic areas are neurology, oncology, hematology, immunology, gastroenterology , and pulmonology.