Senior Clinical Scientist, Drug Development Hematology

The Senior Clinical Scientist supports various deliverables for effective and efficient Clinical Development Plan execution. The Senior PD CS is supporting the PD Clinical Science Lead (CSL) with clinical documentation, representing CS on various subteams, acting as a primary point-of-contact for questions on ongoing studies, conducting ongoing medical/safety data reviews, and providing clinical science input into study reporting with considerable independence.

Responsibilities: 

• Provides strategic clinical science support for assigned studies and programs
  
• Supports the CSL in the assessments of clinical programs to support the life-cycle plan and new therapeutic initiatives. 
  
• Member of the Study Leadership Team (SLT)
  
• Has an important role in preparation and participation of HA meetings, interacts with corporate partners and cross-functionally across Roche/Genentech
  
• Leading role in a pivotal study filing.
  
• Clinical review of study data, identifying and evaluating study data trends, outliers, protocol violations etc. Works with CSL, clinical operations, data management and potentially other groups to develop and communicate relevant medical inquiries
  
• Gathers and analyzes data and information necessary for regulatory submissions, scientific publications, scientific presentations, investigator meetings, etc.
  
• Reviews and/or writes additional clinical science documentation and/or Clinical Science input into other documentation managed by other Roche groups (e.g. protocol summaries, investigator brochures etc.)
  
• Build relationships and scientific outreach within the scientific community
  
• Participate in cross-functional teams for the evaluation of new development ideas, franchise medical strategies and business development assessments
  
• Contribute to authorship and review process for scientific publications and presentations.
  
• Supervises, coaches and guides less experienced Clinical Scientists
  

Requirements: 

Advanced Clinical/Science degree (PhD or PharmD) highly preferred. Experience in working in a clinical team (or equivalent). Extensive knowledge of clinical research and successfully worked across Phase II-III drug development projects. Broad experience in the principles and techniques of data analyses, interpretation. In-depth knowledge of medical aspects of GCP, ICH requirements and relevant Health Authority guidelines and regulations. Ideally, health authority filing experience. The ideal candidate will have at least 6 years experience at a leading pharmaceutical or biotechnology company and an in-depth understanding of Phase II-III drug development. 

 

The skills required for success in the job include scientific and analytic ability, ability to think strategically and tactically, an interest in applied clinical research, ability to work effectively, efficiently and collaboratively in multifunctional and multinational teams, as well as the ability to multitask and prioritize. The candidate must demonstrate ability to evaluate, interpret and present complex scientific data.