Roche’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase II – III) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients. The PD Medical Director participates in development of the Clinical Development (CD) strategy and is responsible for developing the CD plan and ensuring effective and efficient CD plan execution.
Participates in and/or leads the relevant Clinical Science Team (CST
Designs and develops clinical studies
Collaborates with others in development of clinical sections of investigator brochures, presentations and other materials
Ensures investigators are appropriately and thoroughly briefed, in a timely manner, on medical/scientific matters relating to each study
Acts as a medical monitor for assigned studies
Conducts ongoing reviews of medical/safety data
Responsible for ensuring correct medical/scientific data interpretation for interim and final study reporting
Who You Are
We are looking for an industry professional with a MD and good medical competence and extensive experience in Phase II / III trials, including filing, coupled with demonstrated scientific interest and curiosity. In addition you:
Experience submitting an NDA/BLA to HAs in Europe and/or the U.S.
4 or more years of pharma/biotech experience with clinical trials, in depth understanding of Phase II-III drug development
Experience authoring aspects of a global CDP or full clinical study protocol
Comprehensive understanding of product and safety profiles
Versed in medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry
for more than 40 years, using human genetic information to develop novel medicines for serious and
life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious
illnesses. Please take this opportunity to learn about Genentech where we believe that our employees
are our most important asset & are dedicated to remaining a great place to work.
The next step is yours. To apply today, click on the "Apply online" button.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.