Six PhD students Clinical Pharmacology

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Six PhD students Clinical Pharmacology

Omschrijving

Organisatie
Department of Clinical Pharmacology, vac.no FMW-7465

Afdeling

Department:
In the department of Clinical Pharmacology the research program streches over the whole life cylce of drugs. Starting with early famacological/pathofysiological research (lead by prof. dr. R.H. Henning), fase 1 to 3 clinical drug research (lead by prof. dr. D. de Zeeuw) to investigations into the use of drugs in daily practice and how this use can be optimized (prof. dr. F.M. Haaijer-Ruskamp). Within the last theme, the department has a major role in the education of pharmacotherapy in the medical curriculum (prof. dr. P.A. de Graeff).
The Top Institute Pharma is a collaboration of industrial and academic research teams. It focuses on improving efficiency in drug discovery and development. TiPharma offers their researchers an advanced training program in scientific and business skills. See www.tipharma.com.
One prominent project of the TI Pharma portfolio is Escher.
The Escher programme’s primary intention is to improve the scientific quality and efficiency of late phase drug research. As a consequence, time to registration may be reduced while maintaining the safety of new registrations.
To reach this objective three complementary work packages are initiated:
1. Regulatory barriers and opportunities in drug innovation,
2. Innovative models of testing and monitoring efficacy and safety of new drugs,
3. Knowledge preservation, management and learning.

Functiebeschrijving
Job description:
For Work package 1, we have 1 PhD position available:
Scientific and political drivers of the current drug regulatory environment, perspectives for improvement.
The aim of the project is to identify and understand regulatory barriers, and thus to improve drug development, without compromising the quality of safeguarding public health. First, the project will aim to identify and understand how do regulatory “hurdles” affect drug development in an international context. Thus, initial (comparative) study will focus on regulatory aspects and knowledge management between EU and US.

For Work package 2, we have 3 PhD positions available:
PhD-position 1. Connecting BIOMARKERS and proxy-outcomes across different phases of drug development.
The aim of the project is to assess current evidence and new methodological and study design options for the use of biomarkers and proxy-outcomes for benefit/risk assessment across different stages of drug development. The use of two biomarkers for cardio-renal protection will be in the first instance evaluated. The project will assess several methods, including different research designs (series of clinical trials, case-control studies, cohort studies), meta-analysis, bayesian approaches, validation principles.

PhD-position 2.Use and validation of BIOMARKERS and proxy-outcomes in pre- and post-registration setting.
The aim of the project is to assess whether biomarkers and proxy-outcomes may be used as proxy-measures to decrease the duration of drug registration. Practical applications (testing of two biomarkers of cardio-renal protection for drug registration) will be applied. The study will evaluate the use of biomarkers for Go/No Go decision making and will assess registration requirements for biomarkers in view of (conditional) drug approval.

PhD-position 3. Improving patient SAFETY through better methods of clinical risk management.
The aim of the project is to develop risk minimization models to address the most common adverse drug events in diabetes mellitus, heart failure, and arrhythmia. The risk minimization models will be developed based on current available databases and focus group discussions with specialists, pharmacists, and general practitioners. The model will be tested in clinical practice.

For Work package 3, we have 2 positions available:
PhD-position 1. Streamlining DATA management in regulating pharmaceutical products.
The aim of the project is to streamline DATA management in regulating pharmaceutical products, including kinetics, dynamics, efficacy and safety of population exposure. The project will address several issues, including European Medicines Evaluation Agency (EMEA) guidelines, benefit-risk balance, comparability, assay validity.

PhD-position 2. An intelligent, automated learning, knowledge system to recognize patterns in regulatory and drug development DATA.
The main objective of the project is to build a web-based medicinal product repository to compare, analyze and present different research questions, based on safety and efficacy, systematically, within and across medicinal products. Second, the repository will identify by means of a common interface and with a common search engine whether patients exposure was adequate in terms of numbers, duration, dose and subgroups. Third, the repository improve consistency in the review process.

Functie-eisen
Requirements:
For the positions on work package 1, 2, and 3.1, the candidate should have an MD, PharmD or degree in biomedical sciences or related field. Knowledge in epidemiology or some experience in research are appreciated. Motivated to work in cutting edge drug development research.
For the position on work package 3.2, the candidate should have a degree in medical informatics or related field.

Arbeidsvoorwaarden
Uren per week: 0.
Conditions of employment: The UMCG offers emplyment for a period of four years. A salary at the first year from € 1.966,- untill € 2.519 at the last year gross per month. The conditions of emplyment comply with the Collective Labour Agreement for Medical Centres (CAO-UMC). Additional conditions of employment: you will work as a team member of a TI Pharma project. The project team comprises academic and industrial partners. In this case, the partners are the University Medical Centre in Utrecht, The University Medical Centre in Groningen, The Erasmus University in Rotterdam, The Utrecht Institute of Pharmaceutical Sciences, Organon, GSK, Winap, Amgen and MSD. You will attend a unique drug discovery education and training program. Additional Information: Additional information about the project can be found on the website of TIPharma (www.tipharma.nl) under Research – Project Escher (2.3, 2.4, 2.7, 3.1 and 3.2) For the positions on Work package 1 and 2, you will be working in the Department of Pharmacology of the University Medical Center Groningen, which is part of the GUIDE graduate school. You can find out more about the department at: http://www.rug.nl/umcg/faculteit/disciplinegroepen/klinischefarmacologie/introduction. For the position on Work package 3.1, you will be working in the Department of Epidemiology of the University Medical Center Groningen, which is part of the GUIDE graduate school. You can find out more about the department at: http://www.rug.nl/umcg/faculteit/disciplinegroepen/epidemiologie/mission. For the position on Work package 3.2, you will be working in a collaborative project of the Department of Epidemiology at the University Medical Center Groningen, and Department of Business & ICT at the Faculty of Economics and Business. You can find out more about the Business & ICT department at: http://www.rug.nl/feb/faculteit/vakgroepen/businessandict/index, and about the epidemiology department at: http://www.rug.nl/umcg/faculteit/disciplinegroepen/epidemiologie/mission. Application: The UMCG would prefer to receive your appliciation in a digital way. You can use the digital application form below this page. If you wish, you can apply by regular mail, in that case you can send your application to: Universitair Medisch Centrum Groningen Bureau Arbeidsvoorziening, Wervingssecretariaat Postbus 30.001 9700 RB Groningen The deadline is 8-1-2008.
Maximum salaris: 0.

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