Senior Clinical Scientist, Neurology & Rare Disease

Switzerland, Basel-City, Basel
United Kingdom, Hertfordshire, Welwyn

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• Job facts

At Roche, we believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives and we are fearless in both decision and action. And we believe that good business means a better world.

That is why we come to work every single day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

As a Senior Clinical Scientist you assist the Clinical Science Leader in all areas of project and study planning, evaluation, documentation and medical monitoring, including IND and annual report development, protocol development, medical monitoring for patients in the program and ongoing clinical review for safety. You will be responsible for all scientific aspects of a study.

• You support in a timely, medically and scientifically sound development of the clinical portions of an integrated development plan (IDP)


• You assist with the quality and timely preparation of all PDC documents submitted for approval


• You ensure GCP, Clinical Operating Guidelines and Standard Operating Procedures are followed within PDC


• You liaise with appropriate departments inside and outside PDC to define the timing of discussion with the FDA and other regulatory bodies on format of clinical NDA and submission issues.


• You assist in the preparation of clinical progress reports for regulatory agencies before they are reviewed by line managers.


• You ensure correct data interpretation including interim and Final Study Reports before they are approved.

Qualifications:

We are looking for a professional with a PhD, Pharm D or equivalent qualification and good medical competence in pediatric neurology or neurology. A background in neuromuscular disease (e.g., DMD or SMA) basic or clinical research is helpful. In addition you:

• Have a good clinical research experience in working on a clinical team (or equivalent) and in working in a diverse environment


• Are a strong team player, you have the ability to broaden one's knowledge base and to get “up to speed” on a new indication within six months


• Are able to evaluate, interpret & synthesize scientific data, you can verbally present and critically discuss clinical trial data in internal and external meetings


• Can interact within Pharma Development to accomplish goals while providing needed coaching, support or disciplinary action at appropriate times.

Are you ready to apply? We want someone who thinks beyond the job offered - someone who knows that this position can be a rare springboard to many other opportunities at Roche.

Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.

• Who we areAt Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
  
  Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.


• Job facts
  
  
  
  • Location Switzerland, Basel-City, Basel | United Kingdom, Hertfordshire, Welwyn
  
  
  • Function Research & Development
  
  
  • Subfunction Clinical Operations
  
  
  • Schedule Full time
  
  
  • Job level Individual contributor
  
  
  • Job type Regular
  
  
  • Division Roche Pharmaceuticals
  
  
  • Posted since 2019/01/10
  
  
  • Job-ID 201812-132006
  
  


• Get in touchMr. Mathieu Vetter


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