HAYA Therapeutics is a precision medicines company developing RNA-guided programmable therapeutics targeting the regulatory genome for serious health conditions including cardiovascular disease and cancer. The company is using its innovative cell-state modifying platform to gain novel insights into the biology of long non-coding RNAs (lncRNAs), - the ‘dark genomes’ information processing features and ‘source code’.
Position
As the Biomarker Lead, you will play a crucial role in developing and implementing biomarker strategies across HAYA's pipeline, with a focus on our RNA-targeted therapeutics. Working with cross-functional teams, you will identify, validate, and implement biomarkers that support our drug development programs from preclinical development through clinical trials and validation.
Responsibilities
Develop and execute biomarker strategies in line with HAYA's therapeutic development focus on long non-coding RNAs & the regulatory genome.
Identify, develop, and validate biomarkers for target engagement, pharmacodynamics, and patient selection. Provide leadership as necessary to promptly implement these new technologies in clinical practice.
Design and oversee biomarker-related studies in preclinical models and clinical trials. Collaborate with internal teams (R&D, Clinical Development, Regulatory Affairs) and external partners incorporating biomarker data into drug development decision-making.
Keep updated on the latest technological advances in biomarkers and the relevant regulatory legislation for RNA therapeutics and fibrotic diseases.
Manage biomarker data analysis and interpretation, presenting findings to internal and external stakeholders.
Prepare regulatory submissions and participate in biomarker strategy interactions.
Lead the strategy for identifying and developing genetics and genomics-based biomarkers leveraging HAYA’s data science and functional genomics platform capabilities.
Qualifications
PhD/MD with experience in molecular biology, biochemistry, or a similar field, and over 5 years of experience in the industry developing and translating biomarkers to clinic. The incumbent should preferably have experience in RNA therapeutic development and/or fibrotic disease-related applications, but the ability to work across other different therapeutic areas will also be considered
Proficient in RNA biology, gene regulation, and fibrosis mechanisms
Expertise in multiple modalities of biomarkers: e.g., circulating fluid biomarkers (RNAs, proteins, and metabolites), imaging biomarkers, and digital biomarkers, as well as the analytical skills required for their application
Have previously worked on biomarker design and use in clinical trials, and be familiar with regulatory requirements
Outstanding project management and communications skills
Effective in a high-intensity, dynamic, and collaborative team environment
Please send your CV and Cover Letter tojobs@hayatx.com. Please specify the position you are applying for and use the “BL-PM” identifier in your cover letter and email subject line.
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