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Clinical Scientist in Immunology
vor 2 Wochen
**INTRODUCTION**:
As a preferred supplier for F. Hoffmann - La Roche Ltd. in Basel, we are looking for an individual as
**Clinical Scientist in Immunology (M/F/d)**:
- for a 6 months contract, with immediate start date.
**ASSIGNMENT DESCRIPTION**:
Tasks & Responsibilities:
- Provide operational and scientific leadership expertise in all aspect of study planning, evaluation and documentation for a number of assigned global Phases I-II studies within the agreed strategy, budget and timelines
- Lead the clinical protocol development process by engaging line function input at the appropriate time
- Retain operational and scientific input into the finalization of clinical development plans and study related documents, including but not limited to protocols, reports, investigator brochures, IND annual reports, Health Authority (HA) briefing books, IND submissions and responses to Health Authority's (HA) questions
- Lead the clinical trial data and medical-scientific review, final analysis and interpretation including the development of clinical trial reports, publications and internal/ external presentations, jointly with the medical lead
- Provide direction to the global multidisciplinary, cross-functional Study Management Team (SMT) to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedure, within a matrix environment
**REQUIRED PROFILE**:
- Must Haves:
- Minimum PhD in Life sciences or MD**:
- 5-10 years of experience with strong expertise in Drug development and clinical studies (5-10 years ideal)**:
- Experience in running and setting up clinical trials**:
- Strong GCP knowledge**:
- Scientific expertise documented by publications, ideally has experience writing clinical study protocols**:
- Able to evaluate, interpret & synthesize scientific data**:
- Experience in writing, reading, running team meetings and writing minutes. Organize dates and meetings.
- Solid presentation skills
- critically discuss clinical trial data in internal and external meetings
- Solid IT skills in programmes inducing; google, google mail, g-drive, word, xls, ppt and google counterparts
- Fluent written and verbal communication in English
- Excellent communication skills and ability to interact and align a variety of stakeholders. Lead a team with
- members from different functions
Nice to Have:
- Expertise in drug development for IBD indications (Crohn's, UC)
- Scientific or drug development expertise in GI indications in general
- Medical expertise in drug development
***Application process**: Interested? You can find more information here:
