Position Summary

HAYA Therapeutics is seeking a Senior Medical Director, Cardiovascular Medicine, and Clinical Development to lead the clinical development execution for HAYA’s lead asset in Hypertrophic Cardiomyopathy (HCM). In this highly visible and impactful role, you will execute the clinical strategy and oversee the development of innovative Antisense Oligonucleotide (ASO) targeting novel therapeutic approaches for HCM. This includes leading early-phase clinical studies and integrating precision RNA medicine into clinical trial design. You will collaborate closely with executive leadership, the preclinical research team, and external partners to advance HCM therapeutics through all stages of clinical development.

As Senior Medical Director, you will collaborate with multidisciplinary teams to develop novel treatments, providing first-in-biology solutions for patients suffering from HCM and cardiomyopathies more broadly.

What’s in it for me?

In this leadership role, you’ll have the rare opportunity to be at the forefront as the clinical development function is being established. As the first in this position, you will partner closely with the CMO, providing input and insights as the function takes shape while playing a pivotal role in executing clinical development plans to advance HAYA’s lead asset.  You’ll tackle key challenges in cardiovascular medicine by leading early-phase clinical studies and integrating precision RNA medicine into trial design. Reporting directly to the CMO, you’ll drive the execution of clinical trials while collaborating with a high-performing team to advance cutting-edge therapeutics.

If you're a problem solver, this role is for you. You will address challenges in clinical protocol development, study execution, data monitoring, and regulatory compliance while advancing RNA therapeutics for HCM and other cardiovascular conditions to transform patient outcomes.

Joining HAYA means being part of an innovative, collaborative team dedicated to pioneering treatments that will reshape the clinical landscape and improve the lives of patients suffering from HCM and related cardiovascular conditions.

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Key Responsibilities:

Therapeutic Area and Leadership:

• Serve as Senior Medical Director for hypertrophic cardiomyopathy (HCM), executing the clinical strategy for Antisense Oligonucleotide RNA-based therapeutics and precision RNA medicine.
• Lead the integration of learning from precision RNA science and translational studies into clinical development execution, working closely with leading RNA scientists, biomarker discovery, and patient stratification to enable personalized treatment approaches for HCM.
• Collaborate with cross-functional teams to drive the clinical HCM RNA therapeutics portfolio, ensuring the program aligns with the company’s strategic goals and scientific objectives.
• Oversee the execution of clinical plans incorporating cutting-edge RNA technologies, ensuring the development of innovative RNA-based therapeutics for HCM.

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Clinical Development & Medical Oversight:

• Oversee clinical trial design, contributing to developing clinical protocols and ensuring precision RNA medicine is embedded in trial designs, endpoints, and methodologies.
• Serve as the medical lead and medical monitor for early-phase studies, including first-in-human trials, and ensure rigorous safety and efficacy evaluations for RNA-based therapeutics.
• Work closely and cross-functionally on developing and validating biomarkers, including RNA-based biomarkers, genomic profiling, proteomics, and imaging technologies, to monitor disease progression and therapeutic response.
• Ensure regulatory submissions for clinical trials meet FDA, EMA, and ICH guidelines and provide medical input into IND/CTA filings and other key clinical documentation.

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Cross-Functional Leadership & Collaboration:

• Collaborate with HAYA’s internal preclinical teams, clinical operations, biomarker discovery, and regulatory affairs to ensure the clinical development strategy is aligned with broader company goals.
• Provide expertise in RNA therapeutics and HCM clinical development by leading or participating in clinical advisory boards, steering committees, and data safety monitoring boards (DSMBs).
• Work closely with key opinion leaders (KOLs) and external experts to validate clinical strategies and ensure scientific excellence.
• Review and synthesize scientific literature on RNA therapeutics, HCM, and precision medicine, sharing insights across the company to inform ongoing and future development activities.

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Regulatory Strategy & Clinical Documentation:

• Contribute to regulatory strategy by ensuring alignment with regulatory agencies, including the FDA, EMA, and other global regulatory bodies, for HAYA's pipeline assets.
• Support the preparation and review of regulatory and trial document submissions related to HAYA’s pipeline of RNA-targeting therapies, including IND/CTA filings, clinical trial applications, and other necessary documentation.

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Education & Experience:

• MD or MD/PhD focusing on cardiovascular clinical development, RNA therapeutics, or a related field.
• A minimum of 10 years of experience in basic and/or translational science in cardiovascular medicine and therapeutics, with substantial experience in hypertrophic cardiomyopathy or related diseases.
• Proven experience in leading therapeutic area or asset-level clinical development programs, particularly focusing on Genetic Medicines/Therapies or RNA-based drug discovery.
• Board Certification (or equivalent) or substantial experience in Cardiovascular Diseases, Advanced Heart Failure, Familial/Genetic Cardiomyopathy, or Hypertrophic Cardiomyopathy is highly desirable.

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HAYA Therapeutics is an Equal Opportunity Employer committed to fostering a diverse, inclusive, and equitable workplace where all individuals feel valued and empowered. We provide equal employment opportunities to all qualified applicants and employees without regard to race, color, religion, sex (including pregnancy, sexual orientation, gender identity, or gender expression), national origin, ancestry, age, marital or familial status, veteran status, disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

We prohibit discrimination and harassment of any kind and are committed to ensuring fair and equitable treatment in all aspects of recruitment, hiring, promotion, compensation, benefits, training, and career development.

At HAYA, we believe that diversity of thought, experience, and background drives innovation and strengthens our mission to transform patient care through cutting-edge RNA-based therapeutics.