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