Roche Product Development Neuroscience (PDN) is seeking a Clinical Scientist/ Senior Clinical Scientist (CS/Sr. CS) with substantial drug development experience to join the Satralizumab and Fenebrutinib teams. The position will involve preparing and conducting clinical development studies in China either locally or as part of the global progam for disorders such as Neuromyelitis Optica Spectrum Disorder, Multiple Sclerosis and Myasthenia Gravis. Satralizumab and Fenebrutinib are also being considered as a potential treatments for other conditions.
The CS/Sr. CS assists the assigned Clinical Teams and is responsible for the scientific aspects in a study. Responsibilities include therapeutic area landscaping, Investigator and therapeutic area expert liaison, study planning and evaluation, protocol writing and development, supporting training of study site personnel, acting as a point-of-contact for questions, conducting ongoing medical/safety data reviews, and providing clinical science input into study reporting.
- You assist in the timely, medically and scientifically sound development of the clinical development plan
- You assist with the quality and timely preparation of all Product Development Clinical (PDC) documents submitted for approval.
- You assist in preparation of the scientific content of regulatory documents/interactions
- You ensure GCP and Standard Operating Procedures are followed
- You liaise with appropriate departments inside and outside PDC to support interactions with the regulatory bodies.
- You liaise and communicate with Commercial and Medical Affairs and coordinate clinical efforts on the project-related issues and you assist in the preparation of abstracts, posters, and oral communication for scientific meetings.
- You ensure correct data interpretation including interim and final study reports
- You will have close and frequent, but remote interactions with other members of the global team located in the Basel, UK and in South San Francisco as applicable.
Who you are:
You are someone who wants to influence your own development. You are looking to be part of a dynamic and growing organization where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
We are looking for a professional with substantial drug development and relevant therapeutic area expertise, good medical competence and ability to build strong rapport with thought leaders and principal investigators.
- Candidates must have an advanced degree, preferably a PhD
- Candidates must be strong team players with experience working on multi-functional global development teams
- Candidates must have experience in drug development within the biopharmaceutical industry and/or prior experience in running trials in the Neurology space
- Candidates must be able to evaluate, interpret & synthesize scientific data, and verbally present and critically discuss data in internal and external meetings
- Must have excellent verbal & written communication skills in English
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.
Roche is an equal opportunity employer.Research & Development, Research & Development > Clinical Operations