Roche is seeking a Senior Clinical Scientist with significant drug development and clinical trials experience to help contribute to the late stage clinical development of treatments for multiple sclerosis (MS).
The Senior Clinical Scientist assists the Clinical Science Leader (CSL) in all areas of a project that include but is not limited to study planning, protocol development, medical monitoring, data interpretation and documentation as well as annual regulatory documents update.
- You assist timely and scientifically the CSL in the development of a Clinical Development Plan.
- You ensure that GCP, Clinical Operating Guidelines and Standard Operating Procedures are followed within PDC.
- You liaise and communicate with other functions including operations, biometrics, safety, regulatory affairs and co-ordinate the clinical efforts on the project related issues.
- You assist timely and scientifically the preparation of all documents submitted to regulatory authorities.
- You ensure correct data interpretation and appropriate content of interim and Final Study Reports as well as of PDC documents submitted for approval.
- You collaborate with other functions and assist the preparation of abstracts, posters, oral communication for scientific meetings.
- You will have close and frequent, but remote interactions with other members of the global team located in the UK and in South San Francisco.
Who you are
- You have a PhD or equivalent qualification and good medical competence in neurology
- You have at least 5 years of experience in drug development within the biopharmaceutical industry.
- You have a strong clinical research experience in working on a clinical team (or equivalent).
- You are a strong team player, you have the ability to get ‘up to speed’ on a new indication or on a new program.
- You are able to evaluate, interpret and synthesize scientific data, you can verbally present and critically discuss clinical trial data in internal and external meetings.
- You have excellent verbal and written communication skills in English. You have an international perspective.
- Beyond this you have proven managerial skills – you can accurately assess strengths and develop needs of employees, provides challenging assignments and opportunities for development.
Roche is an equal opportunity employer.Research & Development, Research & Development > Clinical Operations