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Early Development Clinical Scientist

Here at Tizona Therapeutics, we value Patients First!
With this goal in mind, Tizona develops next-generation immunotherapies. 

The successful development of immunotherapies represents one of the most important and exciting breakthroughs in cancer. Despite the recent progress in the field of immuno-oncology, existing immunotherapies are only effective in a relatively small number of patients and types of cancer – a limitation that we hope to overcome.

Tizona’s therapies are designed to modulate the activity of immunosuppressive cells by targeting the cell types and biological mechanisms responsible for immune suppression in the tumor microenvironment.

 

Position Summary/Objective:

  • Responsible for design and execution of assigned clinical trial activities and works closely with clinical development team members to execute activities associated with trial conduct.
  • May lead or support trial level activities for one or more trials with the necessary supervision.

 

Position Responsibilities:   

  • Collaborate and liaise with external partners (e.g., KOLs). 

  • Provide regular and timely updates to manager/management as requested.

  • Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required.

  • Closely engage with clinical trial sites to ensure protocol defined patient population is enrolled and protocol defined procedures and assessments are conducted.

  • Conduct literature reviews.

  • Develop site and CRA training materials and present these at SIVs and Investigator meetings.

  • Review data outputs and clinical narratives.

  • Work closely with the Safety and PV team in reviewing safety reports.

  • Collaborate cross-functionally to monitor clinical data for specific trends.

  • Contribute to the development of Data Review Plan in collaboration with Data Management.

  • Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming.

  • Author/review clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., Pre-IND, IND, IB, DSUR, IRB responses and contribute to regulatory submissions.)

  • Submit clinical documents to TMF

 

Degree Requirements:

  • Degree in Life Sciences (MD, PhD, Pharm D, MPH, MS, RN or similar scientific field preferred).

 

Experience Requirements: 

  • Expectation of  3+ years of experience in clinical science, clinical research, or equivalent, hematology and oncology prior experience preferred.
  • Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.
  • Ability to understand assigned protocol(s) and their requirements.
  • Knowledge and skills to support program-specific data review and trend identification.
  • Intermediate medical writing skills and medical terminology.
  • Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent safety review committees.

 

Key Competency Requirements:

  • Basic planning/project management skills (develop short range plans that are realistic and effective)

  • Basic knowledge of disease area, compound, current clinical landscape.

  • Detail-oriented with commitment to quality

  • Intermediate critical thinking and problem-solving skills.

  • Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)

  • Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., Spotfire, patient profiles, report generating tools)

  • Domestic and international travel may be required (approximately 10-20%)


Tizona Therapeutics is an Equal Opportunity Employer. We value diversity and are committed to providing employees a workplace free of discrimination and harassment. All employment decisions are based on qualifications, merit and business needs.

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