Translational Medicine Program Lead (TMPL)

Position

Translational Medicine Program Lead (TMPL)

Direct Report

Position Summary

The Translational Medicine team at I-MAB Biopharma US Limited located in San Diego, California is seeking a highly motivated Translational Medicine Program Lead (TMPL), at Director/Associate Director level. In partnership with Discovery, Clinical Development, and other functions, the successful candidate will be responsible for developing and implementing the Translational Medicine and Biomarkers strategy for programs entering clinical trials. The TMPL will also be responsible for the evaluation and generation of translational data packages to inform disease positioning for assets as they prepare to enter clinical development. Working closely with the translational research lab within the TM team, she/he will ensure the development of stage-appropriate, fit-for-purpose target engagement/occupancy and pharmacodynamic (PD) assays for FIH and beyond. Together with the Clinical Biomarker team, the TMPL will lead implementation of the TM strategy for programs and support the programs as they advance through development. The position will report to the head of Translational Medicine team in US.

The successful candidate will have a strong oral and written communication skills, be able to work with limited supervision/high level of autonomy, and effectively collaborate with and/or supervise associates within the group and partner effectively with Clinical Development team. Extensive background in immunology, oncology and the drug development process is required.

Key Responsibilities

  • Build the scientific rationale for disease positioning and define translational strategy for assets before they enter clinical development
  • Identify and ensure the development and validation of immunoassays and PD readouts for specific programs entering FIH/early development
  • In partnership with Clinical Biomarker team, implement the clinical biomarker strategy for programs in early and late clinical development, generate and interpret biomarker data enabling go/no go decisions
  • Key goals will include determining proof of mechanism, informing dose selection, defining PD markers and markers associated with clinical response
  • Participate in the preparation and review of the biomarker sections in Clinical protocols, Investigator Brochures, and Clinical Study Report
  • Work effectively with internal translational research lab and CROs to explore novel indications, patient stratification, and new drug combinations for portfolio assets

Qualifications

  • PhD and/or MD with > 6 years of experience in immunology, oncology or related field in industry is required
  • Proven track record of scientific contributions including peer reviewed publications and presentations is required
  • Experience with the development, qualification, validation of immunoassays is required
  • Previous experience with working in a cross-functional team to transitioning candidate molecules from Discovery to FIH/POC studies is preferred
  • Proficiency with designing and analyzing multicolor flow cytometry/FACS-based and/or CyTOF assays is preferred
  • Experience with some of the following molecular biology techniques/platforms: DNA/RNA/protein extraction, QPCR, NanoString, RNAseq and ELISA/MSD/Luminex/Singulex is preferred
  • Outstanding interpersonal and communication skills both written and oral; ability to communicate complex information succinctly
  • Excellent analytical and problem-solving skills and ability to manage multiple projects simultaneously in a fast-paced environment
  • Prior supervisory experience is preferred