|
Product Development
- To perform analysis and overall assessments for new Life Science opportunities; the field covers both new diagnostic approaches, new diagnostic analytes and companion diagnostic,
new methods / technologies and analysers
with respect to their potential application in the Life Science field.
- To analyse and assess each project regarding strengths, weaknesses, opportunities and threats (SWOT-analysis).
- To work out those items and specifications (must, wish, nice-to-have specifications) which are of paramount importance for a successful introduction of a new diagnostic product.
- To work out the pros and cons of different approaches.
- To estimate the necessary work, time and investment in feasibility, proof-principle or clinical studies
which will be necessary to transfer research tests, tools or ideas into
products routinely used in the clinical laboratory or in a niche
market.
- To assist in the development of new products so that they are optimised for the diagnostic routine or research markets.
- To direct and to assist in the optimisation procedure to
ensure satisfactory performance characteristics for new analytes, methods and their application.
- To develop strategies for the follow-ups and commercialisation of 2nd generation products.
Clinical Studies
- To plan, initiate and perform clinical studies for new diagnostic parameters and diagnostic approaches.
- To advise as well as to implement studies
to assess clinical utility (efficacy, clinical specificity, clinical and analytical sensitivity, comparisons and correlation studies) for new diagnostic approaches and diagnostic analytes.
- To make proposals for the choice of the adequate patient- and reference cohort groups.
- To assist in the statistical evaluation and interpretation of clinical data
Marketing
- To initiate and manage new relationships or commercialisation channels.
- To assist in the search for partners and contracting with the identified partners. These partners may be in Europe, in the US or in the Far East.
- To assist in the identification and search for OEM-partners and for licensing in & out activities.
- To take over certain due diligence functions in mergers, acquisitions and divestitures.
Know-how Transfer
- To participate in internal and external training for R&D staff, sales representatives and customers.
|
