Clinical Scientist
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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 Investigators 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:
- Masters 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
Required Experience:
IC
Key Skills
- Laboratory Experience
- Immunoassays
- Machine Learning
- Biochemistry
- Assays
- Research Experience
- Spectroscopy
- Research & Development
- cGMP
- Cell Culture
- Molecular Biology
- Data Analysis Skills
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
