Clinical Scientist Full-time

Job Title

Work Schedule: Standard (Mon-Fri)

Environmental Conditions: Office

Job Description:

Responsibilities:

• 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