The Early Clinical Development, Translational Medicine Oncology Group at Roche is seeking a talented Clinical Scientist who is passionate about translating preclinical discoveries into the next generation of cancer therapies. The successful candidate will provide support for clinical programs that explore a broad oncology portfolio of promising new agents. This portfolio includes an expansive range of antibody-based therapies, molecular targeted therapies and other novel platforms. The organization conducts first-in-human Phase I and Phase II studies with a strong focus on mechanism-based biomarkers.
As a Clinical Scientist you will work with a Translational Medicine leader of the development of study protocol development and will be the key representative to a number of cross-functional teams responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted within one or more programs. You will also provide translational scientific input for final study reports and annual report documentation and assist in high-level IND and NDA documentation processes.
In this role you will also:
- Prepare the translational science component of protocol specific manuals
- Review source document verification plans based on protocol specifications
- Attend and provide scientific support for investigator and consultant meetings as well as study monitor workshops
- Provide training and scientific input to colleagues in clinical operations and study site staff and serve as an expert and problem solver on clinical and medical issues
- Write study reports and assist in preparing materials for use in presentations and advisory committee meetings and help devise responses to regulatory inquiries
- Co-ordinate, prepare and review study results for publications, abstracts, poster presentations and scientific meetings