Jobbörse
04.09.2008
We are looking for a
Pre clinical & clinical scientist (m/f)
The Position:
Responsible for the operational preclinical and (phase I-III) clinical development activities for development projects or clinical life-cycle management activities for marketed products predominantly in the fields of gastroenterology/hepatology, urology, oncology, sports medicine/orthopaedics, gynaecology/women’s health.
Coordinates the international preclinical and clinical development, within a cross-functional, multinational team of internal and external experts, from preclinical through clinical phase I - III trials.
Supports global product registration and product life cycle optimization in close cooperation with the regulatory affairs department.
Prepares the operational Development Plan of the related therapeutic field, including resource planning (timelines, budget).
Responsible for planning and managing the preclinical and clinical timelines, managing the appropriate budget (external preclinical & clinical grants and CRO management fees) according the agreed Development Plan and approved resources.
In close cooperation with the Pharmacovigilance Department responsible for drug safety aspects during clinical development.
Analyses incoming preclinical and clinical data, relevant medical and scientific information and initiates if necessary actions or decisions as appropriate.
Has responsibility for providing medical and scientific expertise for assigned projects, including currently marketed products, new product opportunity evaluation and registration support.
Acts to ensure state-of-the-art clinical program and trial design, including planning, execution and reporting:
> Prepares the Clinical trial outlines and contributes input to CRO and investigator selection for approval.
> Ensures the quality, timely completion and approval of final integrated clinical trial reports, whether generated in-house or externally.
> Implements steps to reduce clinical development costs and time-lines.
> Has responsibility for preparing selected clinical trial results for publication.
The Ideal Candidate:
Is a graduated MD, ideally with clinical experience.
Has a minimum of three to fives years experience in a similar position with a research based pharmaceutical company, an OTC company or a CRO.
Has experiences in preclinical development and intimate knowledge of all aspects of the clinical research processes as well as a high interest in working in an international environment.
Is proficient in all aspects of the drug development process and has a full knowledge of advanced clinical trial design.
Should have a good to excellent knowledge of GCP and world wide regulatory requirements relating to the assigned area.
Is highly motivated with the sound analytical skills necessary for exercising independent judgment in developing methods, techniques and the evaluation criteria for obtaining results.
Possesses organisational talent, a structured scientific approach, well developed teamwork skills and a high commitment to his/her professional standards.
Will be required to focus on multiple issues at one time, and must have the ability to organise and direct diverse activities in a changing environment, also under time pressure.
Fluency in both written and spoken English is essential.
Please send your application documents to the Human Resources Department to the attention of Mrs. Fischer.
MADAUS GmbH
Personalabteilung
Frau Fischer
Colonia-Allee 15
51067 Köln
Fax.: 0221-8998-736
E-Mail: bewerbung[at]madaus.de