Clinical Scientist - Waltham, United States - TScan Therapeutics

TScan Therapeutics

Verified Company

Waltham, United States

2 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Position Summary:

Responsibilities:

Work alongside the Medical Monitor to support all TCR-T clinical trial activities related to the solid tumor program
Support the authoring of clinical trial documents such as protocols, CRFs, ICFs, IBs, CSRs etc. as well as clinical sections of regulatory documents
Work alongside the clinical operations teams and the CROs to ensure quality of clinical trial deliverables from trial planning and start up, through clinical trial conduct all the way to trial close up, database lock and CSR drafting.
Collaborate and liaise with clinical sites to support overall clinical trial participant management, data review activities and facilitating issue resolution
Support the development of data review plans and monitor clinical data for specific trends. Perform ongoing and timely clinical trial data review in the form of listings, tables, patient profiles and live clinical database
Develop site and CRA protocol

- and product-related training materials and present these at SIV and Investigator meetings

Conduct literature review, review clinical narratives, review coding listings, participate in SAE reconciliation

Requirements:

Advanced degree in life sciences, healthcare, or other clinically relevant degree (MD, PhD, Pharm D, MS, RN, or another scientific field)
35 years of experience in Clinical Development Phase 3 oncology clinical trials within pharma/biotech
Versed on GCP/ICH, study design, basic statistics, and clinical operations
Intermediate medical writing skills and medical terminology
Basic planning/project management skills
Detailoriented critical thinker, adept in problemsolving with a commitment to quality
Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet daytoday challenges with confidence and professionalism)

About TScan:

TScan Therapeutics was founded in 2018 by a small group of scientists led by Dr. Stephen Elledge (Harvard Medical School/HHMI). TScan is discovering and developing novel TCR-engineered T cell therapies for the treatment of cancer.

TScan's discovery platform is centered around a breakthrough technology that enables the rapid, comprehensive, and genome-wide identification of the peptide antigen targets of T cell receptors.

This technology greatly enhances our ability to understand the specific antigens that drive important disease processes, including tumor cell recognition by the immune system, self-reactivity in autoimmune disorders, and acquired immunity in infectious disease.

TScan is using the platform in oncology to discover new TCR/target pairs and to rapidly move novel TCRs into clinical development.

**Do YOU have the anatomy of a TScanner?