The biomarker group within pRED Early Clinical Development Oncology is working on deciphering the complexity of human tumor- host biology by leveraging clinical trial biomarker data for oncology pipeline programs. The ultimate goal is to identify biomarkers that will tailor cancer therapies to patients.
We are seeking a highly motivated Biomarker & Experimental Medicine Leader (BEML) to join the group and help to lead the biomarker efforts for our pipeline molecules on cancer immunotherapy and molecular targeted therapies. In this role, you will be responsible for the analysis of high and low dimensional data for reverse translational applications, the development, execution and the oversight of biomarker strategies for two or more projects.
Responsibilities include, but are not limited to the following tasks:
- You are accountable to develop and apply state-of-the-art analytical concepts using high and low dimensional pre-clinical and clinical data to enable discovery and validation of new biomarkers.
- In addition, you are accountable for all project biomarker deliverables. This includes the definition of the project biomarker strategy including its implementation in pre-clinical and clinical testing. Your efforts will be aligned with the global project team, the clinical team and the disease area strategy.
- We ask you to provide a biomarker plan (including time lines/ time frame, data analysis plan) and to identify and prioritize biomarker platforms. Furthermore, you will define the sampling strategy for a given project.
- The delivery of biomarker-specific sections of project-level documentation is up to your hands.
- You lead a multifunctional biomarker team of various functional members from the Roche organization in a matrix setting.
- In addition, you support the preparation, review and presentation development to internal governance bodies as well as for external communication.
- You hold a PhD, MD or PhD/MD degree in a relevant scientific field e.g. bioinformatics, immunology, pathology, molecular biology, cancer genetics, cancer biology, hematology, molecular oncology or bioinformatics with profound experience and exposure to discovery and development of biomarkers in cancer immunology, either in a research or clinical setting
- You look back on at least 5 years of experience (beyond post-doctoral training) in drug development and translational research including discovery, development and utilization of BMs or BM-technologies either in an academic and/ or industry setting, supported by a strong publication record or equivalent contributions
- Working knowledge of the fundamental concepts of analytical approaches used in preclinical and clinical settings as well as extensive understanding of external resources and initiatives in data analytics, bioinformatics and high-throughput OMICs data are your strong points.
- Advanced knowledge of different OMICs platforms used in early clinical development
- Extensive understanding of the principles of reverse translation and its application in early clinical development
- We can trust in your experience and understanding of diagnostic product development as well as clinical pharmacology.
- A background in regulatory, safety, operations or biostatistics would be an advantage.
- You can work as an individual contributor but you are an experienced matrix leader and decision maker with strong leadership skills to influence and motive teams.
- As a team player you integrate easily into a pro-active and inspiring global organization. You are able to prioritize your work in order to focus on individual goals as well as on team deliverables. We can trust in your outstanding presentation and communication skills as well as in your ability to distill complex issue plus develop and clearly articulate Solutions.