Myeloid Therapeutics is an immuno-oncology company developing its propriety ATAKTM myeloid cell program to cure cancer. ATAKTM cells are autologous myeloid cells that have been engineered to unleash their power to cure cancer. The platform technology can be applied broadly to numerous oncological conditions. Our science has demonstrated activity against hematological and solid tumor targets in preclinical models and is looking for a Translational Medicine Scientist to join the company and build a team to enable the initiation of clinical trials for the lead candidates, translating these findings to the clinic. The company, having operations in Cambridge, MA, was founded by Ronald Vale and Siddhartha Mukherjee.
The Translational Medicine Scientist will work closely with the Chief Medical Officer, Clinical Operations, and preclinical scientists and will be focused on development of novel immuno-oncology therapeutic agents. This position offers the opportunity to take on a leadership role in a growing organization.
- Provide scientific and technical expertise in areas of biomarker discovery and development as well as mechanism of action of ATAK cells
- Lead development of the translational and biomarker strategy for all clinical programs.
- Analyze translational medicine data in support of the development of biomarkers.
- Develop clinical trial supporting, validation-ready PK, PD and immunogenicity assays to support IND enabling non-clinical studies and early phase clinical studies.
- Efficiently document method development and manage technology transfer to CROs.
- Manage CRO activities to generate critical reagents (antigens, poly-and mono-clonal antibodies, and relevant cell lines) for supporting clinical bioanalytical assays.
- Collaborate with external groups on nonclinical studies to define biomarkers of disease and potential combination strategies.
- Interface closely with Clinical Operations to operationalize translational plan and serve as subject matter expert to guide troubleshooting.
- Responsible for the translational medicine content of clinical regulatory documents including protocols, INDs, CTAs, IB, CSRs and preclinical expert reports.
- Hire, manage and mentor and develop staff to support assigned activities.
Qualifications & Education
- Ph.D. or M.D./Ph.D with 5+ years of experience in translational research and biomarker development
- Direct experience in developing PD and anti-drug antibody assays in support of non-clinical and early clinical trials is required. Experience in cell therapy is ideal.
- Experience in assay development and validation in accordance with regulatory guidelines and best practices.
- Experience authoring laboratory manuals and appropriate sections of clinical documents
- A track record of successful execution of translational medicine objectives in clinical development demonstrated by abstracts, peer-reviewed publications and/or patents
- Collaborative and comfortable working as part of a cross-functional team
- Excellent written and verbal communication skills
- Ability to think strategically
- Ability to proactively predict issues and solve problems
- Regional/global regulatory requirements for biomarkers
- Emerging research in immuno-oncology