- Position zu besetzen ab 15. November 2020
- Permanent-ID OCR-FL-1116
- Branche Pharma
- Beschäftigungsform Freelance/ Contracting
- Standort Deutschland
- Kategorien Beschäftigungsform, Branche, Freelance/Contracting, Pharma
The role of the “Companion Diagnostics (CDx) Lead“ is a strategic and scientific role with a focus on strategy, diligence and guidance pertaining to the implementation of Companion Diagnostic (CDx) strategies, with a special emphasis on Molecular Testing, specifically when Next Generation Sequencing (NGS) is applied. The candidate is leading a team of experts from different contributing functions including Regulatory affairs (drug related and also companion diagnostics related), Translational Innovation Platforms (TIPs), Global Clinical Operation (GCO), Global Clinical Development (GCD), Global Business Franchise (GBF) and other functions represented in the Global Product Team.
Who you are:
- The candidate is able anticipate and mitigate risks, communicate in an open, transparent and timely manner, and take accountability in all CDx related aspects.
- The candidate is able to pick up, understand, define, and integrate specific requirements of global Companion Diagnostic development (FDA, EMA, PMDA, NMPA, etc…) in drug development programs where molecular testing is applied.
- The candidate is able to show strong inspirational leadership skills and needs to be able to deliver with high probability of success, with close attention to detail while adhering stringently to aligned budgets.
- This is a highly visible and interactive role requiring broad scientific understanding while integrating drug development and regulatory affairs into the proposed solutions.
- Active leadership of a cross-functional group of people is required.
- Commercialization experience considered an additional asset.
Bachelor’s degree with 10+ years of experience, master’s degree with 5+ years, or a PhD with 3+ years of experience in companion diagnostics and biomarker research
- A PhD with 10 plus years of experience in bringing molecular based companion diagnostics to market, throughout development and registration. NGS-experience is a plus.
- Has led a dedicated team of experts focusing on CDx development strategies with a special emphasis on molecular testing
- Proactively and transparently consider regulatory requirements and CDx technology details, with the ability to distill and deliver, holistic and over-arching global CDx development plans across a number of development programs
- Strategically develop and implement molecular testing (preferably NGS) in clinical trials including both tissue and plasma-based testing strategies (other liquid biopsy strategies will also be considered). This includes implementation across broad geographies, minding specificities of regulatory agencies abroad.
- Support teams with the implementation and improvement of molecular testing strategies at initiation of clinical trials, during trials, during approval process, at market entry and in the evolving market situation (diagnostic life-cycle management)
- Support regulatory activities required for the successful implementation of testing at initiation of clinical trials, during trials, during approval process, at market entry and in the market situation
- Interface and support commercial functions in launch readiness and planning, providing support on go-to-market strategy, competitor landscapes, and product differentiation with an emphasis on CDx
- Enables translational research, oncology (targeted therapies and IO)
- Good data analytics skills/understanding will be required for collaboration with various data analysts.
Duration: 12 months
Availability: 4-5 days / week
On-site support: 80%
Remote support: 20%