Clinical Scientist

Thermo Fisher Scientific · Shanghai

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Work Schedule

Environmental Conditions

Job Description

Responsiblities:

• Assists with target research, potential indication research, and competitive landscape analysis for cell therapy programs
• Supports the clinical input to the clinical development plan at early stages of the program under guidance of senior team members
• Assists the science-to-man sub team (TSST) in integrating biology, translational and clinical science into the program strategy
• Contributes to the preparation of internal governance presentations and slides for clinical trials
• Supports the preparation of clinical data for governance presentations
• Assists in the preparation of program level documents such as the Investigator's Brochure and Development Safety Update Report (DUSR)
• Monitors medical & scientific literature for important developments and trends in cell therapy, summarizing key findings and their potential impact on program strategy with support from senior clinical scientists
• Assists in providing clinical input to the development and review of data for pre-CDID compounds in collaboration with Bio-scientists and Translational scientists
• Supports the review of publication content and contributes to publication strategy development
• Supports the study lead and/or program physician in clinical aspects of study design and execution
• Assists with the Clinical Development Plan (CDP) and Clinical Study Protocol development in alignment with the approved CDP
• Supports clinical data review and interpretation at the study level with guidance from the study or program physician
• Assists in the compilation and interpretation of data for dose escalation committee/safety review committee meetings
• Supports the preparation of clinical and other data for governance and regulatory presentations
• Provides medical and scientific support to specific studies as directed by the program clinical lead/study physician
• Assists with protocol updates, amendments, and other strategic documents
• Supports the review of Clinical Study Reports
• Assists in developing investigator/site relationships to support site selection and study start-up activities
• Supports the development and implementation of IIT and/or IND study strategy, serving as a liaison between the project team and external clinical research activities
• Assists with investigator and site relationships for clinical proposal reviews, protocol review and approval
• Helps identify and communicate risks, raises quality issues through appropriate channels, and maintains communications with key stakeholders
• Supports senior clinical scientists in representing the project internally and externally with key external experts

Other:

• Actively learns from and collaborates with cross-functional team members
• Operates in compliance with Good Clinical Practice (GCP) and relevant regulatory guidelines
• Participates in continuous learning and professional development activities
• Contributes to team knowledge sharing and documentation

Required Qualifications

Education:

• Master's degree in Clinical Sciences, Biomedical Sciences, Life Sciences, Pharmacy, or related field

Experience:

• Minimum 1 year of experience in a pharmaceutical or biopharmaceutical company
• Basic understanding of clinical drug development processes or medical research
• Foundational knowledge of clinical practice and disease biology, with demonstrated ability to rapidly acquire new knowledge
• Exposure to cell therapy, oncology, immunology, or related therapeutic areas (preferred)

Skills & Competencies:

• Strong collaborative and communication skills with the ability to work effectively in cross-functional teams
• Ability to synthesize scientific and clinical information from multiple sources
• Demonstrated problem-solving skills and solutions-oriented approach
• Proficiency in scientific literature review and analysis
• Strong attention to detail and organizational skills
• Ability to manage multiple priorities and work in a fast-paced, matrix environment
• Proficiency in English (written and verbal)
• Experience with Microsoft Office suite and scientific databases

Desired Qualifications:

• Knowledge of CAR-T or other cell therapy modalities
• Experience in competitive landscape analysis
• Familiarity with regulatory requirements (FDA, EMA, NMPA, etc.)
• Understanding of GCP and ICH guidelines
• Experience with clinical trial design or execution
• Publications in peer-reviewed journals

What We Offer

• Exposure to cutting-edge cell therapy development across multiple therapeutic areas
• Mentorship from senior clinical scientists and therapeutic area leaders
• Opportunity to contribute to the development of life-changing medicines
• Professional development and career growth opportunities
• Collaborative, innovative work environment

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