‍About the job

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.

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Main responsibilities:

1. Develop and execute biomarker strategies in line with HAYA's therapeutic development focus on long non-coding RNAs & the regulatory genome.
2. 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.
3. 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.
4. Keep updated on the latest technological advances in biomarkers and the relevant regulatory legislation for RNA therapeutics and fibrotic diseases.
5. Manage biomarker data analysis and interpretation, presenting findings to internal and external stakeholders.
6. Prepare regulatory submissions and participate in biomarker strategy interactions.
7. 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

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Core Values:

• Creativity & Innovation. Scientifically curious and bold. Generates new and creative approaches to problem solving. Positive ‘can-do’ attitude. Views the toughest challenges as the greatest opportunities for personal growth and company innovation. Able to challenge convictions and dogma.
  

• Teamwork. Fully engaged in facilitating personal and team success. Reaches out to peers and cooperates with the team to establish an overall collaborative work environment. Often solicits and responds well to constructive feedback. Possesses good written and oral communication skills with the ability to clearly and concisely convey ideas and opinions.
  

• Flexibility/adaptability. Adjusts quickly to changing strategic and tactical priorities. Comfortable with ambiguity. Self-starter mentality.
  

• Fast-acting/efficient. Proactive and quick decision making with a strong work ethic to produce high-quality results while fostering a positive work environment. Focuses on key tasks and priorities. Demonstrates tenacity and willingness to go the distance to get something done.
  

• Integrity. Does not cut corners. Does what is right not just what is politically expedient. Speaks plainly and truthfully. Earns trust and maintains confidences. Expects a high level of personal performance and team performance. Follows-through on commitments.
  

• Critical thinking. Learns quickly. Demonstrates ability to proficiently understand new information and to independently pursue and achieve meaningful outcomes. Able to structure and process qualitative/quantitative data and draw key conclusions.