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

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