Therapeutic Asset Lead and Director, Clinical Science

At HAYA Therapeutics, we are revolutionizing RNA-guided genome-targeting therapies to treat fibrosis, heart failure, and other serious chronic diseases associated with aging. Our innovative platform leverages long non-coding RNAs (lncRNAs) - key regulators within the "dark matter" of the genome - to develop first-in-class, highly specific therapies that reprogram disease-driving cell states into a healthy and resilient state, tackling disease at its roots. Following the successful close of our Series A financing, HAYA is well-positioned to advance our pipeline and execute on key scientific and operational milestones, including the advancement of HAYA's lead program, HTX-001, toward the clinic for the treatment of non-obstructive hypertrophic cardiomyopathy (nHCM). In recognition of our scientific innovation and potential global impact, we have been named one of the 100 early-stage companies selected for the World Economic Forum's 2025 Technology Pioneers. As a fast-growing biotech, we offer an entrepreneurial, science-driven environment where you'll have a direct impact on shaping our programs and advancing the future of RNA medicine. Position Summary The Therapeutic Asset Lead and Director, Clinical Science, serves as a hands-on scientific and operational leader responsible for the execution of clinical trials within our clinical development portfolio. This role combines deep scientific expertise with operational excellence to implement study execution, protocol development, regulatory compliance, and data interpretation for assigned clinical studies. Working collaboratively with internal teams, Contract Research Organizations (CROs), and clinical investigators, the Director ensures all studies are conducted with the highest standards of scientific rigor, regulatory compliance, and operational efficiency. This is a tactically focused, execution-oriented position that operates "in the trenches" of clinical development, distinct from strategic portfolio management roles. Key Responsibilities Therapeutic Asset Leadership Together with the CMO, the Therapeutic Asset Lead and Director Clinical Science will implement a clinical trial design operationalizing the overall HTX-001 clinical development strategy and will drive implementation, ongoing oversight of clinical study execution, and contribute to all related study documents. Collaborate cross-functionally across the organization to drive the advancement of the therapeutic asset, ensuring that the program aligns with the company's strategic and business goals and scientific objectives, while maintaining the highest degree of patient safety Drive execution of HTX-001clinical plans, enabling the development of innovative RNA-based therapeutics for HCM, and demonstrating the power of Haya's therapeutic platform more broadly Regulatory Affairs & Documentation Prepare, co-author, review, and finalize regulatory documents and submissions as needed Support regulatory agency interactions, including preparation of responses to agency questions and participation in regulatory meetings Maintain current knowledge of evolving regulatory guidelines and ensure compliance across all assigned studies Coordinate with regulatory affairs teams to ensure seamless submission processes Medical Monitoring & Safety Oversight Serve as the medical monitor for early-phase studies, including first-in-human trials, and ensure rigorous safety and efficacy evaluations for HTX-001. Provide clinical oversight (in collaboration with the Chief Medical Officer) for assigned studies, serving as the point of contact for day-to-day medical questions and operational decisions Review and evaluate adverse events, ensuring appropriate medical judgment and timely and compliant regulatory reporting Cross-Functional Leadership & Collaboration Partner effectively with clinical operations, clinical program management, regulatory, and contracted functions at CROs to execute clinical studies at the highest level of GCP Provide clinical and scientific guidance during site selection, study initiation, and investigator training activities Lead cross-functional study teams to achieve critical study level milestones and timelines Facilitate communication between internal teams and external partners (CROs, investigators, vendors) 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. Scientific Excellence & Knowledge Management Interpret complex clinical data and develop scientifically sound conclusions for internal and external stakeholders Support the development of key scientific messaging, publications, and presentation materials Maintain current expertise in relevant therapeutic areas, competitive landscape, and scientific literature Contribute to the continuous improvement of clinical development processes and standards Required Qualifications Education & Experience MD or MD/PhD with 5-10 years clinical development in biotechnology, including experience in cardiomyopathy or related field Board Certification (or equivalent) or substantial experience in General Medicine and Cardiovascular Diseases. Additional certification and/or experience in Advanced Heart Failure, Familial/Genetic Cardiomyopathy, or Hypertrophic Cardiomyopathy is highly desirable. Demonstrated experience in clinical study design, protocol and study document development/authorship, and study execution Comprehensive knowledge of Good Clinical Practice (GCP), ICH guidelines, and global regulatory requirements Experience with FDA, EMA, and other international regulatory agencies Proficiency in clinical data analysis and interpretation Core Competencies Excellent written and verbal communication skills, with the ability to translate complex scientific concepts into actionable plans Demonstrated leadership capabilities in cross-functional, matrix environments Strong attention to detail and commitment to quality and compliance Ability to work effectively under pressure and adapt to changing priorities Preferred Qualifications Board certification in Cardiovascular disease (and previously internal medicine) or equivalent Clinical experience in cardiovascular medicine Previous experience working with CROs and managing vendor relationships Track record of successful IND acceptance, trial initiation, and other regulatory agency interactions Experience in start-up/biotech environment is highly desirable Publication record in peer-reviewed journals 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.