Genentech/Roche is seeking an Assistant or Associate Medical Director to join the Atezolizumab Lung Cancer development team within Product Development Oncology. Atezolizumab (also known as MPDL3280A; anti-PDL1) is an investigational monoclonal antibody designed to interfere with PD-L1. There are 11 ongoing or planned Phase III studies of atezolizumab across certain kinds of lung, kidney, breast and bladder cancer as well as a wide range of studies investigating atezolizumab in combination with other agents.
Roche’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase II – IIIA) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients. The Assistant or Associate Medical Director role involves clinical representation on cross-functional teams responsible for the design, implementation, medical monitoring, data interpreting, reporting and publishing of studies conducted within the program.
- Participates in the overall management, planning, evaluation and documentation of projects and studies
- On-going clinical development activities including:
- Preparation of regulatory documents and interaction with global regulatory authorities
- Monitoring and reviewing incoming data
- Analysis, presentation and interpenetration of on-going studies and published data
- Interactions with health authorities and expert bodies
- Close collaboration with drug safety, regulatory affairs, medical affairs and clinical trial operations
- Participation in the preparation of abstracts, posters and presentations for scientific meetings and congresses
- Developing and writing clinical plans and protocols ensuring that they are scientifically sound
- Contributes clinical science input into the relevant therapeutic/disease area scientific strategy
- Collaborates with a variety of internal and external partners and stakeholders
- Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease areas