- The individual will be responsible for the oversight of biomarker programs, translating scientific discoveries into clinical strategies (predictive/pharmacodynamic/resistance biomarkers, molecular response endpoints, indication selection and combination strategies).
- Responsible for the development and successful implementation of biomarker components of clinical trials, including protocol development, implementation and execution of stratification strategies, clinical biomarker and pharmacodynamic assays in clinical studies.
- Responsible for evaluating CROs for assay/technology platforms and data analysis capabilities, creating SOWs and interfacing with CROs for execution of services including supporting management and oversight of Central Lab partners.
- Maintain routine and close partnership with clinical science and operations, working together to ensure integration of scientific and clinical strategy with sample collection, processing, storage, and data transfer.
- Contribute to the development of relevant sections of regulatory documents, e.g., Investigators' Brochures, pre-IND and IND submission documents, responses to Health Authorities questions.
- Build relationships and collaborations with scientific leaders, KOLs, academic partners, and CROs.
- Regular publication of scientific and methodological results is strongly encouraged, and scientists are expected to develop into externally recognized leaders in translational sciences who influence the field of personalized healthcare in oncology.
- PhD, MD, or PhD/MD degree in a relevant scientific field (e.g., oncology/hematology, cancer biology, molecular biology, immunology) with a minimum of 5 years of experience working in the biotechnology or pharmaceutical industry.
- Prior experience focusing on biologics, oncology, and immune oncology programs from a translational medicine perspective.
- Prior experience with designing biomarker strategy, acquiring and analyzing biomarker data from clinical trials and integrating with clinical endpoints to ensure impact on development program.
- Experience working with clinical and translational operations, as well as relevant CRO's to design kits, clinical lab manuals and data transfer specifications to guarantee integrity of sample collection, handling and analysis.
- Familiarity with establishing and analyzing data from immunohistochemical (simple and multiplex), flow-based, multiplex ELISA and gene expression assays (i.e., Nanostring or RNAseq) is desired.
- Ability to work with large, multi-omic data sets and familiar with techniques for exploring associations of biomarkers with clinical outcomes.
- Knowledge of integration of patient selection biomarker strategy and companion diagnostic development is desired.
- Must be a motivated, results-oriented self-starter, and demonstrate effectiveness and growth in a fast-paced and dynamic environment.
- Thinks strategically and is motivated by science behind drug development as well as drug development challenges.
- Ability to collaborate, lead, influence and motivate others.
- Outstanding presentation and communication skills.
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Associate Director/Director, Translational Oncology - South San Francisco, United States - ALX Oncology Inc.
Description
ALX Oncology Inc. (ALX) is a clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway. Our lead candidate, evorpacept (ALX148), is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. For more information about us, please visit
ALX is looking for a highly motivated Associate Director/Director, Translational Oncology with scientific and clinical expertise in immune oncology to expand our Translational Oncology team. The candidate will work within a multi-disciplined Clinical Development team and will be responsible for contributing to the design and implementation of translational and clinical biomarker strategy for the company's growing oncology portfolio.
Responsibilities:
Salary Range:
Associate Director: $178,000-$205,000
Director: $215,000-$245,000
ALX Oncology is an equal opportunity employer. All applicants should be legally entitled to work for any employer in the US. Title and salary are commensurate with experience. Our compensation program includes competitive salary, equity participation and attractive bonus incentives.
