The Senior Clinical Scientist assists the Development Lead / Clinical Science Leader in all areas of clinical development strategy, project and study planning, study protocol development, execution, ongoing medical data review, evaluation, documentation and reporting. You will be responsible for all scientific aspects of a study or studies and have a leading role providing clinical science input into regulatory strategy and documents.
You assist in the timely medically and scientifically sound development of the clinical portions of an integrated development plan
You conduct ongoing medical/safety data reviews and provide clinical science input into study reporting.
You represent clinical development on various sub-teams or other appropriate forums, supporting training of study site personnel, acting as a primary point-of-contact for questions and inquiries to development on your study/program
You liaise with appropriate departments inside and outside PDC to define the timing of discussion with regulatory bodies.
You have regular external interactions with cooperative groups, therapeutic area experts, vendors, partners and also participate in external interactions with health authorities.
You ensure GCP, Clinical Operating Guidelines and Standard Operating Procedures are followed
You mentor more junior clinical scientists
We are looking for a professional with a PharmD, PhD or equivalent qualification and good medical competence. A background in neurology basic or clinical research would be advantageous but not mandatory. In addition:
10 or more years clinical trial experience preferable (minimum of 6 years clinical trial experience in pharma/biotech industry)
Has extensive knowledge of clinical research and has successfully worked across Phase II - III drug development projects
Have 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
Strong interpersonal, verbal communication and influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally
Genentech, Inc., is an American biotechnology corporation which became a subsidiary of Roche in 2009. Genentech Research and Early Development operates as an independent center within Roche. As of February 2020, Genentech employed 13,638 people.