Roche

Lead Clinical Scientist , Drug Development Hematology - Hemlibra

Company
Roche
Location
Welwyn
Salary
Competitive
Posted
22 Apr 2021
Closes
22 May 2021
Ref
202101-101100
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
The Clinical Scientist supports various deliverables for effective and efficient Clinical Development Plan execution. The Clinical Scientist 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.

Key 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. 
  • Supports preparation and participation of HA meetings, interacts with corporate partners and cross-functionally across Roche/Genentech
  • Interacts externally with cooperative groups, vendors, key opinion leaders (KOLs)
  • 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
  • Supervises, coaches and guides less experienced Clinical Scientists


Requirements: 

We are looking for a professional with advanced Clinical/Science degree (PhD or PharmD), highly preferred. Experience in working in a clinical team (or equivalent). Knowledge of clinical research and successfully worked across Phase II-III drug development projects. Experience in the principles and techniques of data analyses and interpretation. In-depth knowledge of medical aspects of GCP, ICH requirements and relevant Health Authority guidelines and regulations. The ideal candidate will have at least 4 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.

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