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 maycontribute 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 willhave the opportunity tocontribute to exploratory safety analyses and be involved incross 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 You Are

Required

• You hold a bachelor's Degree focused in Biology, Biomedical Sciences and/or other relevant Life Science areas; Advanced Clinical/Science Degree is highly preferred (e.g. PhD, PharmD, MSN, MPH, etc).

• You have 1-2 years of clinical development, industry experience, with demonstrated expertise in both early and late stage R&Ddrug development, including discovery sciences.

• You have a good understanding of the multidisciplinary functions involved in drug development; including ICF, CST and Safety Data Review activities.

Preferred

• You have the ability to independently carry out the majority of the study conduct responsibilities; you have worked across various therapeutic areas in drug development

• You have demonstrated experience with protocol review and assessment.

• You have proven ability to work effectively and efficiently within cross-functional teams, e.g. Study Leadership Team/CSL with therapeutic area-relevant clinical trial experience or clear ability to adapt with transferable skills

• You have 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

Relocation benefits are not available for this job posting.