04.01.2012Head of Pharmacokinetics & Pharmacometrics (m/f)
AiCuris - founded in 2006 – is a specialist for infectious diseases. Its activities comprise discovery, research and development of novel antiviral and antibacterial agents in the indications HIV, Herpes, Hepatitis B and C, Human Cytomegalovirus and (multi)resistant bacterial infections treated in the hospital. With its highly innovative pipeline AiCuris addresses specialist markets and severe, potentially life threatening infections with high medical need.
Currently AiCuris is offering the position of a:
Head of Pharmacokinetics & Pharmacometrics (m/f)
The role of this individual is to manage a team of Pharmacokineticists and Bioanalysts and to provide PK/PD input and scientific concepts for AiCuris projects. Furthermore, he/she will successfully design, control and report PK/PD studies in the respective subject area in collaboration with the AiCuris project team, external consultants and service providers and be responsible for the PKPD part in our clinical trials.
Main tasks & responsibilities:
- act as a PK project representative in Phases I to III development projects and provide PK/PD input into such projects
- participate in preparation or review of the clinical parts of regulatory documents, such as IB, IMPD
- provide PK/PD input into regulatory documentation
- ensure the optimization of formulation activities for all development compounds with external resources and partners
- contribute to the proper pharmacokinetic characterization of AiCuris project compounds in non-clinical and clinical studies, i.e. participate in the generation, analysis and reporting of PK data in preparation for clinical development and make recommendations on next steps and/or go-no go decisions
- assist in the selection of development compounds with regards to an optimal PK/PD profile
Skills and Qualifications, preferred:
- PhD in an appropriate area e.g. Chemistry, Biochemistry or Pharmacology
- at least 10 years of experience in the pharmaceutical industry
- a clear understanding and working knowledge of the application of Pharmacokinetics, Pharmacodynamics and Drug Metabolism in the discovery and development process
- proven skills in PK or PK/PD data analysis, predictive modeling and illustrative presentation of such data (including medical writing)
- an understanding of clinical development strategies and tactics coupled with experience in the evaluation of PK derived from clinical trials (Phases 1 to 3)
- extensive knowledge of up to date in vitro and in vivo PK methodologies used to support drug discovery
- experience of dealing with regulatory agencies with regard to PK matters
- knowledge of the CRO environment and ideally experience of contracting work to such organizations
- wide experience of managing and providing leadership
- positive & constructive attitude, people management competencies and trustworthy
- good organizational skills with the ability to work on several projects and set priorities
- strong verbal and strong written communication skills
- fluent written and spoken English skills, German skills are helpful
- ability to work as a team player in a flexible and dynamic organization
- highly proficient in MS Office Suite
We offer an exciting and challenging job in an expanding and innovative company with an excellent R&D portfolio and a highly motivated team exhibiting many years of Big Pharma and Biotech R&D experience.
How to apply
To apply, please submit your full application inclusive your curriculum vitae and salary requirements exclusively via email in electronic form (one pdf-file). Please apply solely in English language!
| AiCuris GmbH & Co. KG |
Phone: +49 202 317 63 2599 |
Fax: +49 202 317 63 1177 |
| Attn. Daniela Höltig |
Email: jobs@aicuris.com |
Web: www.aicuris.com |
| Friedrich-Ebert-Str. 475 |
Building 302 |
DE-42117 Wuppertal |
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