Clinical and Translational Biomarker Lead
With this goal in mind, Tizona develops next-generation immunotherapies.
General Position Overview:
Tizona Therapeutics is seeking a highly motivated scientific leader to join our team and support the preclinical and clinical development of innovative immune-oncology therapeutics. This position is responsible for devising and leading the discovery and implementation of biomarker and diagnostic strategies across Tizona’s first-in-class drug development programs. Experience in developing biomarkers for clinical trials, managing others, and strong knowledge of immunology and tumor biology is required. The individual will work in a cross-functional environment to design, execute, and interpret translationally-focused experiments. Activities include biomarker identification, assay validation and implementation, and generation of data that supports patient stratification and pharmacodynamic evaluation of drugs and mechanism of action in the clinical trial setting.
Qualified candidates should be independent, hard-working, highly motivated, and possess a proactive attitude and strong desire to contribute to the identification and validation of biomarkers to support indication selection and early clinical development of our candidate therapeutics. Candidates should also fit in well with the collaborative, rigorous, and entrepreneurial spirit of our company culture.
Key Accountabilities/Core Job Responsibilities:
Independently formulate translational strategies for the discovery, development, and implementation of biomarkers for ultimate use in clinical settings
Collaborate with Research, Clinical Operations and Clinical Development to identify potential tumor and immune correlates with response for research-stage programs to inform early development strategies
Develop and direct in vitro and ex-vivo assays to translate preclinical data into meaningful clinical biomarkers for advancing drug candidates
Collaborate cross-functionally (e.g., discovery, in vivo pharmacology, bioanalytical, clinical development, and clinical operations) to ensure successful operational execution of biomarker plans
Maintain state-of-the art knowledge on biomarker approaches, particularly for targeted oncology and immuno-oncology therapies
Provide oversight of the development, validation, and execution of clinical biomarker assays,
In close collaboration with the Clinical Development Operations, Biometrics, and Bioinformatics functions, manage the timely testing of clinical trial samples and the analysis and reporting of the associated data
Establish internal biomarker capabilities and outsourcing of biomarker assays as needed
Communicate data and strategies effectively to key stakeholders, including internal team members, senior management, and external partners
- Experience with one or more of the following is strongly preferred:
- In vitro functional assays using primary human immune cells (e.g., MLR, T-cell proliferation, suppression assays, macrophage polarization/differentiation, etc.); experience with myeloid cell-based assays a plus.
- Experience in cell line generation (overexpression and KO cells) and molecular based techniques (DNA/RNA isolation, qPCR etc.).
- Skilled in assay development/establishment and troubleshooting.
- Experience with primary immune cell isolation and characterization by multi-parameter flow cytometry.
- Experience with cytokine analysis (ICC, ELISA, MSD, Legendplex etc.).
- Experience with microscopy (IHC, IF, Confocal) and Incucyte.
- Experience working with mice is strongly preferred; injections (i.p., i.v., s.c.) and tumor measurements.
- Maintain detailed record of experiments and results. Experience with electronic lab notebook is a plus.
- Highly motivated, independent, and creative individual with excellent communication and interpersonal skills.
- Effective at working in a highly collaborative environment.
- Strong leadership skills, self-motivated, adaptable to a dynamic environment.
- Computer skills including proficiency in the use of Microsoft Word, Excel, PowerPoint, Prism, and FlowJo.
Education and Experience Requirements:
•Ph.D., or MD/PH.D immunology, oncology, or relevant scientific field with a well-documented background of scientific achievement, and 8+ years of biotech/pharmaceutical drug discovery and development experience
•Deep understanding of cancer biology, clinical oncology and/or immunology •Familiarity with design and implementation of in vivo pharmacology studies in oncology
•Experience in translating disease biology and the pharmacology of therapeutic agents into clinical biomarker strategies that address key questions during clinical development and impact clinical decision-making
•Working knowledge of established and advanced molecular, cellular, and imaging technologies (e.g., immunohistochemistry, flow cytometry, and gene expression) in clinical trials to demonstrate drug pharmacology and inform patient selection strategies
•Demonstrated success managing a functional group
•Experience working with CROs for the development, transfer and deployment of diagnostic assays preferred, including budget management
•Strong strategic and critical thinking skills, with a demonstrated ability to analyze, interpret, and clearly communicate (written and oral) complex biomarker data and its impact on program and regulatory strategy.
•Ability to collaborate, lead, influence, and motivate others
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.