Position Summary

HAYA Therapeutics seeks an experienced and highly motivated Director of Clinical Operations to play a critical role in executing our clinical trial for patients with nonobstructive hypertrophic cardiomyopathy (nHCM). In this role, you will provide operational leadership to ensure the successful planning, implementation, and oversight of the clinical trial for our lead asset.  The position requires strong organizational skills and the ability to work collaboratively in a fast-paced, growing biotech environment.  You will work closely with internal and external stakeholders (including translational development, clinical science, regulatory science, biostatistics and data management, biomarkers, and quality teams) to drive the seamless execution of clinical trials and programs.

What’s in it for me?

This is a rare opportunity to be the first clinical operations professional at HAYA Therapeutics, where you’ll have the autonomy and influence to help shape the development of a new function from the ground up. You won’t be stepping into a program that’s already in motion; instead, you’ll be joining at the very start of clinical execution and playing a pivotal role in shaping how our trials are conducted. You'll work closely with an experienced and collaborative executive team, including the CMO and Senior Medical Director, and contribute directly to the development of a first-in-class RNA-based therapeutic in cardiology. At HAYA, your work will have an immediate impact on a science-driven, entrepreneurial environment that values initiative, expertise, and innovation.

Key Responsibilities

• Clinical Trial and Program Leadership: Lead the execution and management of clinical studies and trials, ensuring compliance with regulatory requirements and industry best practices. In addition to HAYA’s initial Phase 1 study for its lead asset, the program is anticipated to transition into Phase 2 and may also involve investigator-initiated studies. Experience managing across a broad range of studies is critical.

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Responsibilities include active participation in trial design, including drafting and amending clinical trial protocols in close collaboration with the study physician and other cross-functional team members.

• CRO Management: Participate in the selection process and lead contracting. Oversee and manage relationships with Contract Research Organizations (CROs) and other external vendors to ensure high-quality deliverables, including compliance with protocols, within timelines and budget.
• Cross-Functional Collaboration: Work closely with internal and external stakeholders, including translational development, clinical science, regulatory science, biostatistics and data management, biomarkers, and quality teams to drive seamless execution of clinical trials and programs.  You’ll frequently facilitate clinical operations meetings.
• Clinical Trial Drug Supply Management: Lead clinical trial drug supply planning and oversight to ensure investigational products are available at sites when needed and in alignment with trial timelines. This includes collaborating with internal teams and external partners to forecast demand, monitor inventory, manage drug shipments, and track returns and accountability. The role requires close coordination with Clinical, CMC, Regulatory, and CRO/vendor teams to proactively identify and mitigate supply risks, ensure compliance with global regulations, and support efficient study execution.
• Biospecimen Management and Handling: Develop systems for the collection, processing, storage, shipment, and tracking of clinical trial samples. This includes establishing sample management plans, coordinating with sites, labs, and vendors, and ensuring adherence to protocols, chain of custody requirements, and regulatory guidelines.
• Enrollment Strategy and Monitoring: Collaborate with investigators and cross-functional teams to identify barriers to enrollment and implement targeted strategies to enhance recruitment. Identifying potential challenges in patient recruitment, such as slow enrollment rates, and addressing them proactively.  Oversee the preparation of Informed Consent Forms, advertisements, information leaflets, and subject material.
• Clinical Quality and Regulatory Compliance: Working closely with the Quality colleagues, it is anticipated that the incumbent will implement a robust clinical quality program, which may require authoring essential SOPs and adopting key partner SOPs. Ensure all clinical activities comply with Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and applicable regulatory requirements.
• Safety and Pharmacovigilance: key role in pharmacovigilance activities related to clinical trials. Ensure timely collection, reporting, and analysis of adverse events (AEs), serious adverse events (SAEs), and other safety data throughout the clinical trial process. Develop and maintain safety monitoring plans, risk management plans, and safety surveillance strategies. Collaborating with Clinical Science and CROs to ensure timely data preparation and responses for study-mandated safety review activities. Collaborate with the CRO to ensure compliance with regulatory safety reporting requirements (e.g., ICH E2E, FDA, EMA) and that safety data is accurately conveyed in regulatory submissions and clinical trial reports.
• Budget & Resource Management: Participate in developing and overseeing clinical study budgets, tracking expenditures, and ensuring cost-effective resource utilization. Provide accurate forecasts and track expenditures to ensure cost-effective management of clinical trials. This individual will also develop systems and procedures and manage aspects of site payment management to ensure timely, accurate, and compliant payments to clinical trial sites in accordance with executed agreements. This includes tracking patient visit payments and milestone-based reimbursements, managing payment schedules, and working closely with Finance, Legal, and CRO partners to ensure transparency and meet mandatory reporting requirements as well as alignment across stakeholders.
• Site Management and Enrollment Oversight: The Clinical Operations lead serves as the primary point of contact for Study Site Staff and collaborates with the Medical Director and Clinical Project Manager to establish and maintain strong site relationships. The incumbent will be an important member of the site selection team, managing site start-up and ongoing monitoring to ensure efficient patient recruitment and retention.‍
• Data Integrity & Reporting: Ensure continuous assessment of data integrity and high-quality clinical trial outcomes. Support the preparation of interim data read outs, clinical trial reports, publications, and presentations for internal and external stakeholders.

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Qualifications & Experience

• Bachelor’s or Master’s degree in life sciences, health sciences, or a related field.
• 12+ years of experience in clinical operations, 5+ years at the Director level, with a proven track record in leading and managing multiple clinical trials from initiation to completion.
• Strong knowledge of global clinical development processes, regulatory guidelines (including FDA, EMA, and ICH-GCP), and clinical trial design and execution.
• Experience in managing external vendors, particularly contract research organizations (CROs).
• Expertise in developing and managing clinical study budgets and timelines.
• Excellent communication, presentation, and negotiation skills with the ability to foster a collaborative team environment.
• High degree of adaptability and problem-solving skills in a dynamic biotech environment.
• Experience in RNA-based therapeutics, cardiology, rare disease, or related fields is a plus.
• Ability to travel up to 50% as required for clinical trial oversight and site visits.

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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.

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