To oversee preclinical research and development of biotherapeutic compounds, with focus on CD3- bispecifics, from lead selection through IND filings and initiation of phase 1 clinical trials in oncology indications.
Supervision of up to 12 RAs/PhDs and contributions to strategic decision making on therapeutic modalities and corporate development as a member of the 3T leadership team.
- Overseeing preclinical BioTx program development efforts, from compound generation to lead- and candidate selection, including in vitro and in vivo pharmacology studies, PK-, safety-and translational studies for indication finding, patient selection and combination studies for IND filings.
- Manage cross functional teams to advance BioTx programs toward IND filings, including manufacturing, clinical, PK/PD, diagnostic and regulatory groups.
- Oversee translational science and assay development groups and collaborate with the internal bioinformatics group to identify lead indications, study immunophenotypes of anti-tumor reactive TILs and MOA of resistance.
- Collaborate with the internal protein engineering group to develop novel, proprietary BioTx platforms targeting pHLAs in solid tumors.
- Lead scientific collaborations with large pharma strategic partners, managing scientific direction of BioTx programs for oncology indications.
- Presentations to management, board, investors and external audiences at oncology drug discovery meetings.
- Identify and lead external collaborations with academia and CROs
Background: 8 to 15 years for Pharma/Biotech experience as program leader for BioTx, experience in adoptive T-cell therapies a plus. PhD in Immunology, Cancer Biology, Molecular Biology, Biochemistry or similar.
- Core expertise in preclinical research with focus on large molecules in oncology; from lead candidate selection, through IND submission and initiation of Phase 1 clinical trials.
- Expertise in working with different protein scaffolds (IgG and non-IgG) to select compounds with optimal PK/PD and safety characteristics within CD3 bispecifics and other therapeutic modalities.
- Successful track record in IND filings of BioTx compounds in oncology or autoimmune indications in industrial-, biotech- or academic settings.
- Expertise in developing in vitro T-cell killing assays with BioTx compounds, including normal cells (iPSC, primary cells) and tumor cells (T2 cells, tumor cell lines, organoids)
- Expertise in developing in vivo efficacy models in collaboration with CROs to determine optimal PK/PD characteristics of CD3 bispecific compounds in mouse models
- Translational studies to identify target indications, optimal combination treatments to overcome treatment resistance, optimal dosing regiments and routes of administration, patient selection and drug release assay development.
- Familiarity with overseeing companion diagnostic development for targeted BioTx compounds in oncology.
- Evaluation and selection of CROs to support IND filings, including safety, PK/PD, regulator, clinical and manufacturing.
- Working closely with the program manager to develop program timelines and budgets.