Position: Senior Director Clinical Trials, Diagnostic Assays
Reports to: Chief Executive Officer
The Client
...is a Berlin area-based biotechnology company active in molecular oncology diagnostics. The company is developing novel screening, predictive, and prognostic tests based on gene signatures for early detection of cancer, and for prediction of drug response /outcome in cancer patients. The company operates since 2004 and has established a sizeable research and clinical development team along with various support functions, in total 39 employees at 3 sites.
It is now in the process of launching its first commercial product in blood-based detection/ screening of colorectal cancer (CRC). Its screening test showed a consistently high sensitivity of 90 percent for all four cancer stages (including early stages), and a specificity of 88 percent. It is the best-in-class product and addresses an unmet medical need. Starting in Germany with a central service laboratory, the plan is to expand the business to the US. Further tests in other indications will be developed based on the same technology platform.
The Task
...is to manage various clinical development projects in order for them to soon fulfill all regulatory requirements in the EU and US.
The task requires a project manager thoroughly experienced in clinical operations and quality management, preferably with a firm grounding in regulatory requirements. The focus is on management of the various activities as the company needs to rely on various cooperation partners. Given this critical nature of this role for the company, the individual is highly visible within the organization and the corresponding network.
This position is meant for a professional ...
with about 5-10 years of practical experience in a larger professional set up like a large Diagnostics company
whose desire it is to play a bigger and more influential role in a smaller company with high upside professional
who wishes to directly participate in the company's upside. Both owners and investors are prepared to share such upside with the individual able to progress the company
who shares the enthusiasm of truly innovative technologies
Qualification:
Experience in at least 3 (oncology) clinical trials at the steering committee level (or DMSB experience)
Doctorate in one of the Life Sciences
Expertise in current European and ideally US regulatory requirements for in-vitro diagnostics
Ability to flexibly manage an entire network of partners
Fluency in German and English is a must
Other Job Information:
The technology and services by the Client will set new standards in clinical diagnostics across Europe by allowing for highly reliable and efficient mass screening for cancer. Hence, this position is an excellent opportunity for specialists in molecular oncology diagnostics eager to grow professionally, to work as entrepreneurs and to be rewarded accordingly.
The Client company and technology has already proven itself in many ways and is now poised for execution and growth. The candidate will play an integral role in such growth.
hier bewerben! please apply here
