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 programsSupports the clinical input to the clinical development plan at early stages of the program under guidance of senior team membersAssists the science-to-man sub team (TSST) in integrating biology, translational and clinical science into the program strategyContributes to the preparation of internal governance presentations and slides for clinical trialsSupports the preparation of clinical data for governance presentationsAssists 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 scientistsAssists in providing clinical input to the development and review of data for pre-CDID compounds in collaboration with Bio-scientists and Translational scientistsSupports the review of publication content and contributes to publication strategy developmentSupports the study lead and/or program physician in clinical aspects of study design and executionAssists with the Clinical Development Plan (CDP) and Clinical Study Protocol development in alignment with the approved CDPSupports clinical data review and interpretation at the study level with guidance from the study or program physicianAssists in the compilation and interpretation of data for dose escalation committee/safety review committee meetingsSupports the preparation of clinical and other data for governance and regulatory presentationsProvides medical and scientific support to specific studies as directed by the program clinical lead/study physicianAssists with protocol updates, amendments, and other strategic documentsSupports the review of Clinical Study ReportsAssists in developing investigator/site relationships to support site selection and study start-up activitiesSupports the development and implementation of IIT and/or IND study strategy, serving as a liaison between the project team and external clinical research activitiesAssists with investigator and site relationships for clinical proposal reviews, protocol review and approvalHelps identify and communicate risks, raises quality issues through appropriate channels, and maintains communications with key stakeholdersSupports senior clinical scientists in representing the project internally and externally with key external expertsOther:Actively learns from and collaborates with cross-functional team membersOperates in compliance with Good Clinical Practice (GCP) and relevant regulatory guidelinesParticipates in continuous learning and professional development activitiesContributes to team knowledge sharing and documentationRequired QualificationsEducation:Master's degree in Clinical Sciences, Biomedical Sciences, Life Sciences, Pharmacy, or related fieldExperience:Minimum 1 year of experience in a pharmaceutical or biopharmaceutical companyBasic understanding of clinical drug development processes or medical researchFoundational knowledge of clinical practice and disease biology, with demonstrated ability to rapidly acquire new knowledgeExposure 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 teamsAbility to synthesize scientific and clinical information from multiple sourcesDemonstrated problem-solving skills and solutions-oriented approachProficiency in scientific literature review and analysisStrong attention to detail and organizational skillsAbility to manage multiple priorities and work in a fast-paced, matrix environmentProficiency in English (written and verbal)Experience with Microsoft Office suite and scientific databasesDesired Qualifications:Knowledge of CAR-T or other cell therapy modalitiesExperience in competitive landscape analysisFamiliarity with regulatory requirements (FDA, EMA, NMPA, etc.)Understanding of GCP and ICH guidelinesExperience with clinical trial design or executionPublications in peer-reviewed journalsWhat We OfferExposure to cutting-edge cell therapy development across multiple therapeutic areasMentorship from senior clinical scientists and therapeutic area leadersOpportunity to contribute to the development of life-changing medicinesProfessional development and career growth opportunitiesCollaborative, innovative work environment