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29.07
2024
Biomarkers Lead
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 to jobs@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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