Dieses Inserat auf JobHeidi
For our client, a pharmaceutical company situated in the German-speaking part of Switzerland, we are looking for a - Director, Senior Clinical Pharmacologist AL176-132 - Tasks: -
- Developing a comprehensive understanding of the science and medicine relating to a therapeutic area
- Responsible for one or several projects for all clinical pharmacology related activities
- Supporting transition, communication, and alignment between Preclinical Research, CMC, and Clinical Development
- Defining Clinical Development Plan for the assigned compounds when in early stage development (i.e., phase I and II) or contribute to it when in later stages of development
- Leading the development and maintenance of contacts with key opinion leaders and investigators
- Providing clinical pharmacology expertise within Strategy and Portfolio Board, Scientific Advisory Board, Life Cycle Team, Clinical Team, and Clinical Trial Team (when appropriate)
- Representing Clinical Pharmacology at Health Authority meetings
- Developing a broad, innovative, science-based and forward-looking strategy for projects under his/her supervision
- Leading all aspects of appropriate phase I/IIa studies to ensure study deliverables on time, on budget, and with the appropriate quality
- Responsible for all aspects of study protocols, reports, project summaries, and development plans with regard to regulatory requirements Interpret and present study results to Strategy and Portfolio Board, Clinical Development Committee, Life Cycle Team, Development Team, and externally when appropriate (e.g. investigator meeting, congress, health authorities, etc)
- Contributing to the writing of the clinical sections of regulatory documents (e.g., Investigator"s Brochure, IMPD, briefing books, clinical overviews, safety updates, and clinical summaries of the application dossier)
- Writing position papers and scientific publications when required
- Providing expertise to the PK/PD section of protocol of phase IIb-IV studies
- Attend scientific meetings and review literature to remain abreast of the latest clinical and scientific developments and to maintain up-to-date medical and scientific knowledge necessary to support the Clinical Development Plan
- Performing due diligence and provide clinical pharmacology input during review of new chemical entities and possible in-licensing candidates
- Requirements: -
- Academic background, i.e. a master in sciences (or equivalent), preferably a PhD and/or MD
- Experience in interacting with Health Authorities and in preparation of Due Diligence dossiers
- At least 5 years experience within Clinical Development or equivalent working experience in the pharmaceutical industry and exposure to cross-functional tasks
- Experience with Pharmacokinetic (PK)/Pharmacodynamic (PD) evaluation techniques
- Understanding of the roles and responsibilities of relevant functions involved in a clinical trial (e.g., biostatistics, data management, drug safety, CRO, bioanalytics, etc.)
- Knowledge of regulatory guidelines related to PK and PD studies and evaluations
- Knowledge of ICH-GCP, other relevant Guidance documents and of regulations and requirements for clinical trial authorization in major countries
- Willing and able to travel
- Fluent in English (oral & written)
- Proficient IT skills including clinical applications systems
- If you are interested in this innovative position, please send your complete application documents (CV in German and English, Testimonials, Diplomas, Certificates etc.) to
olivier.mueller@nemensis.com - nemensis ag, the human factor. Your competent recruitment partner, specialized in chemistry, biology/biotechnology, pharmaceutics, medical device/engineering and health care.
