Clinical Scientist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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