Oncology Medical Lead/Clinical Scientist (Early Clinical Development)

Data Science & AI / ML      ·         Shanghai, China        ·         Full time

The Position

Primary Purpose of Job (Job Summary) 主要工作目标（岗位简介）

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 主要职责/责任

(Major functions of the position)（职位的首要职能）

• 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 (e.g., 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 (e.g., CICoR early development committee (EDC) meeting, advisory board meeting)
• Ensure GCP compliance in assigned pharma research and early development studies

Qualification and Experience 能力与经验

Education/Qualifications 教育程度/所获资格证书

• 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 领导者胜任力

• 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 岗位所需胜任力

• 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

Travel Frequency出差频率

     ☐    <25%
     ☒    25-50%
     ☐    >50%

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote.  If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

Job Facts

Job Sub Category: Global Development Clinical Science
Schedule: Full time
Job Type: Regular
Posted Date: Feb 15th 2023
Job ID: 202301-102991

Beginning September 30, 2021, Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date.  This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote.  If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation. 

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