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CEO

Work Experience

Ik heb nog niet als interim manager gewerkt. Mijn sterke punt is bouwen en crisis management. Op de winkel passen is geen sterk punt. Mijn goed ontwikkelde analytisch vermogen zorgt ervoor dat problemen snel doorzien en oplossingen snel gevonden zijn. Gecombineerd met mijn 20-jarige management ervaring lijken mij dat sterke sterke troeven in interim management.


Previous and current functions

1973 – 1979 Teacher Anatomy, Physiology, Physics and Chemistry to the Nursing Training Schools in Utrecht and Amersfoort, NL.
During my years at university I have always worked as a teacher mainly because it was nice to do but also because in order to be good as a teacher it is required to have a better than average knowledge level.
1980 – 1982 Teacher Neurology to the Nursing Training Schools in Tilburg and Utrecht, NL.
Also during my Neurology residency I always worked as a teacher.
1982 Teacher Neurology to the Mensendieck Therapy Training School in Amsterdam, NL.
1980 – 1984 Medical expert to the Blood Banks in Utrecht and Hilversum, NL. During this period I did the physical examinations in potential blood donors and acted as the expert for medical issues. I also defined the policies around AIDS and blood donation in the Netherlands.
1980 – 1984 Forensic doctor for the Utrecht Health Service, a government run organization, NL.
In this function I acted as one of the medical consultants in the Utrecht prison.
1985 – 1986 Consultant and member Medical Staff of the Neurology Department of the University Hosp in Utrecht, NL.
Next to the normal patient related supervisory activities in the Neurology Department I worked as the Neurology Consultant for the departments of Cardiology, Cardio-Surgery and Pulmonary Diseases in that same hospital.
In addition I did research on the cerebral effects of open-heart surgery. During this period we built an expert system to monitor brain function during heart surgery. In case of changes in brain function it allowed timely and expedited medical treatment to prevent permanent brain damage.
1986 – 1991 Medical Advisor Organon in Oss, NL.
I was responsible for clinical development in CNS and did many studies in Depression, Psychosis, Dementia, Epilepsy and Neuropathy. These studies were done in a multidisciplinary team approach.
1991 – 1993 Medical Monitor Organon Inc in West Orange, NJ, USA.
In this period, during which we lived in the US, I was responsible for all safety aspects of CNS compounds. I also wrote the Integrated Safety Summary for Remeron, an antidepressant drug that turned out to be very successful and has been one of the main growth drivers for Organon.
1994 – 1995 Deputy Head International Monitoring Organization Organon in Oss, NL.
After return from the US I acted as the deputy head of the monitoring organization in Europe. The objective of this phase was to learn how to manage large groups of people in a complex organization. At that time the group was about 60 people spread out over 9 European countries.
1995 Change Manager and Project Leader of the Time Compression Initiative (TCI) in Organon Oss, NL.
In 1995 I was asked to take leadership over a large re-engineering project of which the objectives were to decrease development timelines with 50%, to increase productivity with 40% and to match the best developer’s benchmark in the industry. After a diagnostic phase and a solution development phase that took one year I was asked by Organon’s board to lead the implementation from a line managerial position.
1996 – 1999 Head Clinical Trial Operations Organon in Oss, NL
This was the TCI implementation phase. I had line responsibility for all operational groups involved in Clinical Development. These functions were Monitoring, Data Management, Biometrics and Medical Writing but also supporting functions such as Planning (35.000 activities in the planning), Finance (budget 100 million Euros in 1996), Clinical Data Systems and Programming (Clinical IT-systems) and Management Support (Dashboard functions).
A completely new process was implemented together with many changes in responsibilities of departments and functions. The SOPs as well as the Job Descriptions were updated to reflect the process changes and the organization structure was lined up with the changes in the process. A system allowing benchmarking of timelines and quality was implemented to measure the anticipated improvements compared to Organon’s history and with the rest of the industry.
Also the organizational culture was changed to become much more goal oriented.
At the end of implementation the study related timelines had been shortened with 85% and productivity had doubled. We had become a fast developer.
1999 – 2001 Director Clinical Trial Operations Organon in Oss, NL.
This change added the international component to my responsibilities. It became my responsibility as global responsible person for trial operations to implement the TCI approach also in the US and Japan to really globalize the development process.
All systems in use in Clinical Development have been replaced between 1996 and 2001 and while doing this they were all globally harmonized and validated. Our approach drew attention from EMEA and we were invited to help define together with EMEA the “points to consider” (regulations) on Electronic Data Capture Systems. In this period also many FDA, EMEA and KIKO inspections were successfully passed. Monthly visits to the US and Japan to work with local staff on the implementation of the new way of working has given me a lot of international exposure and a deep understanding of the existing cultural differences between these countries.
2001 – 2004 Senior Vice President Global Clinical Development, Organon International Inc., Roseland, NJ, USA.
In 2001 Organon’s head quarters moved from the Netherlands to Roseland in New Jersey. I became globally responsible for all Clinical Development Departments worldwide. The global architectural project and study design responsibilities (content, science) were added to the operational responsibilities I already had. In this capacity I continued to report directly to the Board of Management.
All processes were harmonized globally with clearly defined responsibilities and using central architecture systems. This means that the organization had become truly virtual in the sense that regardless where the work was located it could be done from different locations in the world. This added another 20% efficiency. From a managerial perspective when looking at quality, timelines and costs, Clinical Development was looked at as an internal CRO. In that respect the objectives were derived from the notion that the internal organization had to be competitive with existing larger external CROs. Turn over of personnel in the US, a notorious point of concern, decreased substantially during this period, leading to significantly lower costs for hiring and training. In 2004 the manpower budget was 750 FTEs world wide and a monetary budget (including study related costs) of 350 mio Euros.
Up until that point in time I had been involved in 11 new product registrations, of which 8 had been registered in the past 6 years.
2004 – 2005 Senior Vice President Quality and Drug Safety and Deputy QP, Organon Int, Oss, NL.
On my own request I was given the responsibility to further harmonize and standardize Organon’s quality management across all business functions. This included defining a corporate quality policy fitting with Organon’s mission, vision and values as well as the implementation of a set of harmonized procedures allowing for quality improvement projects and a methodology leading to perpetual improvement of the quality in the entire business cycle of the company.
The drug safety aspect of the function aimed at improving existing processes through further training of personnel, efficiency and productivity increases and intensified use of automation as an enabler. Development of a risk management philosophy with procedures to make it operational aimed at becoming more pro-active with potential drug safety issues. The Deputy QP-function served as the backup contact between Organon and regulatory agencies in the field of drug safety in the broadest sense.
During this period I prepared a detailed plan for the move of clinical development activities into Russia, India and China at the request of Organon’s CEO. My trips to Russia, India and China in light of this task have added to my pre-existing international experience and level of knowledge and understanding of the cultures in these areas of the world.
2005 – now CEO Cardialysis Rotterdam, NL
Cardialysis is a small CRO specialized in Cardiology. It is a full service CRO performing international studies with emphasize on leading edge imaging techniques. During the relative short time I work for Cardialysis a long term strategy, business plan 2006, mission and vision have been defined. Several projects aiming at further innovation of (non-invasive) imaging techniques have been initiated as well as a number of activities aiming at increasing market share, efficiency, productivity and profitability.

Education

Mijn basisopleiding is neuroloog. Het ISEAD Internatonal Executive Program heeft mij de nodige kennis gegeven op het gebied van general management

Skills

Analytisch, gemakkelijk beslissend, actiegericht

Languages

Nederlands, Engels, Duits vloeiend
Frans middelmatig, Italiaans beginnend

Other

Training

1972 – 1979 Medicine, University Utrecht, NL
1980 - 1983 Residency Neurology, St. Elisabeth Hosp/Maria Hosp Tilburg, NL
University Hosp Utrecht, NL
1984 Residency Psychiatry, Lukas Hosp. Amsterdam, NL
1984 Board certification as Clinical Neurologist
1985 Residency Clinical Neurophysiology, Antonius Hosp Nieuwegein, NL
1985 Board certification as Clinical Neurophysiologist (second specialization)

Languages

Dutch Native speaker
English Fluent in word and writing
German Fluent in word and writing
French Moderate
Italian Moderate

Additional Training

1987 Maxwell Course: Training in clinical R&D, London, UK
1988 Clarke Course: Middle Management course, NL
1989 Medical information and communication: Post graduate course in communication, NL
1989 SDG Management course: Middle Management course, NL
1990 The Middle Management Course: Middle Management course, NL
1990 Pharmaco-kinetics: Post graduate course in pharmaco-kinetics, NL
1993 Princeton Conference on drug Development: Participation on personal invitation only, USA
1994 International Course on Business Administration: General Management course, NL
1995 International Executive Program: General Management at MBA level, INSEAD Fontainebleau, F
1998 Strategic R&D Management: course in strategic R&D Management, INSEAD Fontainebleau, F

Research

1983 Measurement of extra-intracranial bypass patency using non-invasive techniques.
Antonius Hosp Nieuwegein, NL
1985 – 1986 Cerebral effects of open heart surgery. University Hosp Utrecht, NL

Other activities and hobbies
Member of the Alphen Community Councel. Alphen is my home town.
Advisor to a mushroom farm on European food additive legislation.
Egyptology (Amarna period).
Running.

Publications
Groenhout, C.M., Gooskens, R.H., Veiga-Pires, J.A., Willemse, J., van Nieuwenhuizen, O.
Value of sagittal sonography and direct sagittal CT of the Dandy-Walker syndrome.
Am. J. Neurorad. 1984; 476 – 477.

Groenhout, C.M.
De waarde van peroperatieve hersenbewaking in open hart chirurgie ter preventie van hersenletsel.
Report Preventiefonds 1990.

Ruigt, G.S.F., Kemp, B., Groenhout, C.M., Kamphuisen, H.A.C.
Effect of the antidepressant Org 3770 on human sleep.
Eur. J. Clin. Pharm. 1990; 38, 551 – 554.

Kasteleijn-Nolst Trenite, D.G.A., van Emde Boas, W., Groenhout, C.M., Meinardi, H.
Parodoxical enhancement of photosensitivity and provocation of myoclonic seizures by the potential anticonvulsant Org 6370.
Epilepsia (N.Y.) 1991; 132, Suppl. 1, 100.

Kasteleijn-Nolst Trenite, D.G.A., van Emde Boas, W., Groenhout, C.M., Meinardi, H.
Paradoxical enhancement of photosensitivity and provocation of myoclonic seizures by the potential anticonvulsant Org 6370.
Pharm. Weekbl. Sci. 1991; 13, Suppl. E, 25.

Kasteleijn-Nolst Trenite, D.G.A., van Emde Boas, W., Groenhout, C.M., Meinardi, H.
Preliminary assessment of the efficacy of the anticonvulsant Org 6370 on photosensitive epileptic patients: paradoxical enhancement of photosensitivity and provocation of myoclonic seizures.
Epilepsia (N.Y.) 1992; 33, 135 – 141.

Van Kooten, B., van Diemen, H.A.M., Huijgens, P.C., Ossenkoppele, G.J., Nauta, J.J.P., Heimans, J.J.
A pilot study on the influence of a corticotropine (ACTH 4-9) analogue on vinca-alkaloid induced neuropathy.
Arch. Neurology (Chicago) 1992; 49, 1027 – 1031.

Heimans, J.J., van Kooten, B., van Diemen, H.A.M., Huijgens, P.C., Ossenkoppele, G.J., Nauta, J.J., Groenhout, C.M.
The influence of an ACTH (4-9) analogue on vinca-alkaloid induced neuropathy.
Neurology 1992; 42, Suppl. 3, Abstr. No. 780S.

Hesselman, L.F.G.M., Wieneke, G.H., Oey, P.L., Groenhout, C.M., van der Graaf, Y., Gispen, W.H., Jennekens, F.G.I.
Evaluatuion of electrophysiological and clinical tests in an exploratory trial of Org 2766 in motor neuron disease.
Neuromusc. Disord. 1992; 3 (4), 319 – 325.

Chraibi, Y., Fernandez, A., Droz, J.P., Said, G., Lhomme, C., Rougier, P., le Chevalier, T., Ruffie, P., Roes, C.B., Blum, A., Groenhout, C.M., van Vliet-Daskalopoulou, E.
A randomized double-blind placebo-controlled study of Org 2766, an ACTH (4-9) analogue, for the prevention of neuropathy induced by cisplatin with or without vinca-alkaloids combination chemotherapy.
Abstract ECCO 7 meeting 1993, Israel.

Van Gerven, J.M.A., Hovestadt, A., Moll, J.W.B., Rodenburg, C.J., Splinter, T.A.W., van Oosterom, A.T., Keizer, L., Drogendijk, T.E., Groenhout, C.M., Vecht, Ch. J., Neijt, J.P.
The effects of an ACTH (4-9) analogue on development of cisplatin neuropathy in testicular cancer: a randomized trial.
J. Neurol. 1994; 241, 432 – 435.

Bravenboer, B., Hendrikse, P.H., Oey, P.L., van Huffelen, A.C., Groenhout, C.M., Gispen, W.H., Erkelens, D.W.
Randomized double-blind placebo-controlled trial to evaluate the effect of the ACTH (4-9) analogue Org 2766 in IDMM patients with neuropathy.
Diabetologica 1994; 37, 408 – 413.

Mahieu, H.F., van Lith-Bijl, J.T., Groenhout, C.M., Tonnaer, J.A.D.M., de Wilde, P.
Selective laryngeal abductor reinervation in cats using a phrenic transfer and Org 2766.
Arch. Otolarynch. Head & Neck Surg. 1996; 12, 393 – 396.

Valk, G.D., Kapelle, A.C., Tjon-a-Tsien, A.M.L., Bravenboer, B., Bakker, K., Michels, R.P.J., Groenhout, C.M., Bertelsmann, F.W.
Treatment of diabetic polyneuropathy with the neurotropic peptide Org 2766.
J. Neurol. 1996; 243, 257 – 263.

Van Lith-Bijl, J.T., Stolk, R.J., Tonnaer, J.A.D.M., Groenhout, C.M., Konings, P.N.M., Mahieu, H.F.
Selective laryngeal reinervation with separate phrenic and ansa cervicalis nerve transfer.
Arch. Otolaryng. Head & Neck Surg. 1997; 123, 406 – 411.

Van Lith-Bijl, J.T., Stolk, R.J., Tonnaer, J.A.D.M., Groenhout, C.M., Konings, P.N.M., Mahieu, H.F.
Laryngeal abductor reinervation with a phrenic nerve transfer after a 9 month delay.
Arch. Otolaryng. Head & Neck Surg. 1998; 124, 393 – 398

Van Lith-Bijl, J.T., Stolk, R.J, Tonnaer, J.A.D.M., Groenhout, C.M., Konings, P.N.M., Tobi, H., Mahieu, H.F.
Effect

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