Oncology Medical Lead/Clinical Scientist

Found in: Talent CN S2 - 2 days ago

Shanghai, China Roche Full time

The Position

The medical lead or principle/senior clinical scientist at the Early Development (ED) department of the China Innovation Center of Roche (CICoR) is responsible for providing medical/clinical expertise in the early clinical development strategy of a CICoR governed global program, driving clinical study design, progress, clinical data review and interpretation, and engaging KOLs, investigators and regulatory agencies; may also act as local medical/clinical expert to support clinical development in China for programs from other Roche research centers.
 

Principle Roles & Responsibilities / Accountabilities

Provide/lead medical/clinical strategy as a critical part of the drug early development project strategy for CICoR programs, key member in Early Development Teams driving projects from clinical candidate selection to full clinical development Provide scientific guidance to the drug research and development strategies across multiple R&D stages, contribute to CICoR discovery project objectives and activities target assessment, translation, and landscape) Develops and own the Clinical Development Plan (CDP) with a vision for CDP from early development to decision to file Drive clinical study design, progress, data review, interpretation and report; lead the development and writing of study protocol, study report and other responsible documents Key-contributor to response to questions from regulatory agency/institutional review boards (IRB); input to and review clinical regulatory documents Assist in the management of studies and support the training and scientific input to clinical operation and study site staff Support clinical safety in the serious adverse events reporting process Provide local medical/clinical assessment for China’s early participation in global clinical trials Represent Roche at congresses and to local and international authorities, contribute to internal and external presentations CICoR early development committee (EDC) meeting, advisory board meeting) Ensure GCP compliance in assigned pharma research and early development studies

Qualification and Experience

Education/Qualifications

MD (preferred) / PhD / PharmD (or equivalent) Five or more years of experience in clinical research in Pharma / Biotech industry Clinical research experience in oncology

Leadership Competencies

Excellent interpersonal skills and collaborative attitude Have a highly self-motivated and innovative mindset to design and/or generate key data Good organizational and multi-tasking abilities to ensure quality and timely delivery of the project deliverables

Job Required Competencies

Excellent understanding of all aspects and scientific methods used in Translational Medicine Role model and established reputation in area of expertise Knowledge of the drug development processes within the context of pharmaceutical industry Good track record of scientific excellence that has significantly impacted research and development of drugs Recognized by peers for scientific excellence, maintains external scientific presence through high quality publications and presentations

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