Clinical Research Scientist The Opportunity The Roche/Genentech Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late stage development (Phase 1b-3) clinical strategies and plans to deliver medically differentiated therapies that provide meaningful improvement to patients. The Clinical Scientist supports the molecule/study/project team for effective and efficient Clinical Development Plan (CDP) execution. This includes contributing to clinical documentation, supporting training of study site personnel, acting as a point-of-contact for questions and enquiries to clinical studies, conducting ongoing medical/safety data reviews, and providing clinical science input into study reporting. Clinical Scientists perform their responsibilities with considerable guidance and direction from more experienced Clinical Scientists and Medical Directors. This position is located on-site in San Francisco, CA. Key Responsibilities You will provide support in developing and/or preparing clinical science information for inclusion into the CDP. You will contribute (with guidance from the Lead Clinical Scientist) to protocol/ICF (writing or amendment), construct appropriate CRFs and coordinate these items cross-functionally as needed; you will contribute (with guidance) to internal/external clinical presentations and communications (e.g. investigator meetings, study site interactions, patient information, study newsletters); You will present at appropriate internal meetings, e.g. Study Leadership Team and may contribute to abstracts, posters, content for scientific meetings. You will work with Lead Clinical Scientists/Medical Directors/Clinical Directors and cross-functional groups to execute the Medical Data Review Plan, data interpretation and contribute to study reporting. You will contribute (with guidance) to Clinical Trial Application (CTA)/Ethics Committee (EC) written interactions, briefing packs, written responses to Health Authority (HA) questions, clinical science data/preparations for HA interactions and clinical data input to regulatory submissions. You will have the opportunity to contribute to exploratory safety analyses and be involved in cross franchise initiatives You will work in a collaborative environment with internal and external stakeholders; you have the ability to work cross functionally with early development stakeholders (specifically in gRED and/or pRED) especially in preclinical sciences, discovery sciences and/or developmental sciences, You have provide the necessary support with governing laws, regulations, guidelines and Roche SOPs on global clinical trial execution is required and some knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA and other relevant guidelines and regulation. Who We Are Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. The next step is yours. To apply today, click on the "Apply for this job" button. Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.