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Collaborative innovation is at the very heart of Roche and we invest more than most other companies in R&D to drive this. We are proud of our history bringing patients first-in-class and best-in-class products as we continue to develop products which have breakthrough designations for high unmet needs. Roche have pioneered a number of novel treatments, having successfully changed treatment paradigm of a number of oncological diseases We have a differentiated portfolio across oncology, inflammation, immunology, infectious diseases, ophthalmology and neurology which covers a uniquely broad spectrum of innovative solutions for healthcare needs of the future. Projects address all stages of prevention, diagnosis and treatment of disease as well as enhancing the quality of life. (Senior) Clinical Development Scientist Lung
Two positions are currently available.
One successful candidate would join the Alecensa (Alectinib) Development Team. Alecensa is a highly selective, CNS active, oral ALK inhibitor that is currently approved for the treatment of patients with advanced NSCLC and has changed treatment outcomes for this group of patients. This position would offer opportunities for personal and professional development, as we look to build upon the foundations of the outstanding data in metastatic lung cancer data by investigating earlier stages of the disease.
As the Alectinib Clinical Development Scientist, you will mainly participate in the ongoing medical review and periodical data review as well as amendment and implementation of protocols/ICFs that support immunotherapy late phase clinical trials in genitourinary cancers. You will also work closely with the medical director to lead/support data cut and data cleaning.
The second successful candidate would join the Pralsetinib Development Team. Pralsetinib is a targeted RET tyrosine kinase inhibitor. RET-activating fusions and mutations are key disease drivers in many cancer types, including lung cancer and treatment options that selectively target these genetic alterations are limited. This molecule is at an earlier stage of development than Alecensa and also offers many opportunities for both personal and professional development.
The Clinical Development Scientist is the single point of contact for any scientific queries from the sites or study management team (SMT). You will lead the SMT in order to achieve integrated data for clinical study reports. You will also be responsible for authorship of clinical science documentation and clinical science input into other documentation managed by other Roche groups. Additionally, you may have the opportunity to present at Investigator meetings, Steering Committee Meetings, teleconferences, and training meetings. and contribute to Health Authority interactions.
At Roche, both teams pride themselves on ensuring that all of its clinical science members are given the chance to gain more strategic drug development experience. Clinical Development Scientists can contribute to, but not necessarily lead, the preparation of clinical study reports, Health Authority interactions and submissions, and clinical development planning, where the opportunity arises.
You will build effective relationships across the organisation, and will collaborate with Medical Directors, Clinical Development Scientists, Data Managers, Safety Scientists, Biostatisticians, Clinical Operations, CRAs and other functions across the globe including San Francisco, Basel and Welwyn. You will also develop new relationships and collaborate with external partners and stakeholders such as investigators, clinicians, scientists and global clinical experts.
You will participate in the relevant Study Management Team (SMT), Clinical Science Team (CST), and will represent PDC in sub-teams which are relevant to your role. This role will be a great opportunity for those seeking for a Clinical Development Scientist role to gain late phase clinical development skill sets/knowledge in oncology Qualifications & Experience:
- Bachelor's Degree required (life sciences preferred)
- Advanced Clinical/Science Degree is preferred (e.g. PhD, PharmD, MSN, MPH, etc.)
- Clinical development experience (e.g. clinical scientist, study management, operation, regulatory, biostats) in industry preferred
- Medical data review experience is a plus
- Excellent collaboration, communication and presentation skills
- Experience in oncology/ haematology is preferred
- Passion to improve patient care and desire to learn new things
- Sound knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, and other relevant guidelines and regulations
Every role at Roche plays a part in making a difference to patients' lives. If you have the commitment to teamwork and innovation that we are seeking and you would like to make your mark and improve lives, we welcome your your application. Roche is an equal opportunity employer.
Research & Development, Research & Development > Clinical Operations