Eloxx Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing novel RNA-modulating drug candidates (designed to be eukaryotic ribosomal selective glycosides) that are formulated to treat rare and ultra-rare premature stop codon diseases. Premature stop codons are point mutations that disrupt protein synthesis from messenger RNA. As a consequence, patients with premature stop codon diseases have reduced or eliminated protein production from the mutation bearing allele accounting for some of the most severe phenotypes in these genetic diseases. These premature stop codons have been identified in over 1,800 rare and ultra-rare diseases. Read-through therapeutic development is focused on extending mRNA half-life and increasing protein synthesis by enabling the cytoplasmic ribosome to read through premature stop codons to produce full-length proteins. Eloxx’s lead investigational product candidate, ELX-02, is a small molecule drug candidate designed to restore production of full-length functional proteins. ELX-02 is in the early stages of clinical development focusing on cystic fibrosis and cystinosis. ELX-02 is an investigational drug that has not been approved by any global regulatory body. Eloxx’s preclinical candidate pool consists of a library of novel drug candidates designed to be eukaryotic ribosomal selective glycosides identified based on read-through potential. Eloxx recently announced a new program focused on rare ocular genetic disorders.
Eloxx is headquartered in Waltham, MA, with regional operations in New Jersey, Pennsylvania and Rehovot, Israel.
Reporting to the Senior Director, Clinical Operations & Site Head, the Director of Clinical Operations will be responsible for leading and managing the execution of Eloxx’s clinical studies from protocol inception through study closure. This key role will manage, plan and execute clinical studies, including creating and managing study timelines, budgets and study management plans in a full out-sourced model to ensure that our corporate goals. This is a great opportunity for visibility and professional growth; the Director of Clinical Operations will manage a team of Clinical Project Managers and partner with the Senior Director to represent the Clinical Operations team cross-functionally and with key stakeholders.
• Ensures that clinical trial projects are properly resourced, managed and executed within budget and in accordance with established timelines and quality standards.
• Oversees the day-to-day clinical operations through a team of Project Managers with a focus on vendor management(e.g., CRO, laboratories), monitoring clinical trial recruitment rate, and coordination of activities.
• Executes high quality, integrated cross-functional plans for the project/clinical trial.
• Represent Clinical Operations in cross-functional teams, clinical meetings and regulatory meetings. Provide regular status updates to senior management.
• Provide strategic input and drive the planning and execution for assigned clinical trials with direct responsibility for time, cost, quality, and risk mitigation.
• Responsible for the oversight of protocols development; protocol preparation, amendments, CRF, informed consent form, operations and other documentation required for conduct of a clinical trial.
• Accountable for internal clinical trial files and documents.
• Participates and manages investigator meetings and follow up.
• Travels for meetings and site visits when necessary.
• Maintains proper communications with other departments to ensure good relationships in connection with ongoing set up and progress throughout trial planning and execution.
• Complex problem-solving abilities with a focus on accomplishing assigned goals and objectives in a dynamic environment.
• A team player who is able to effectively and flexibly lead cross functional teams across diverse cultures, backgrounds and styles.
• Excellent communications and presentation skills, able to effectively inform key stakeholders and management of the status, issues and solutions.
• Strong organizational and planning skills are required, with a proven ability to manage budgets and timelines.
• Detail-oriented, a self-starter and comfortable with broad responsibilities in a fast-paced, small company environment.
• Excellent computer skills, proficiency with project management software tools.
• Prepared to travel internationally (US and EU) for approximately 7-10 days once every 2-3 months.
• Flexibility to work US hours a few times a week.
• Minimum of 10 years’ experience in the pharmaceutical industry, with 5-7 years’ direct experience in planning and managing global clinical trials.
• Strong people management skills with experience managing at least 2 or 3 direct reports required.
• Strong bi-lingual verbal and writing skills in English and Hebrew required.
• Extensive experience managing clinical programs, CROs, budgets and timelines.
• Regulatory/EMA/FDA experience.
• Good working knowledge of medical terminology, physiology and pharmacology and an excellent knowledge of applicable U.S. and international regulations and guidelines.
• Solid understanding of pharmaceutical clinical development processes and have experience with clinical monitoring.
• Ability to thrive in a fast-paced, entrepreneurial environment with busy, high performing colleagues.
• Strong leadership skills and self-awareness.
• Experience presenting to a varied audience, including investors and upper management.
• Bachelor’s Degree or equivalent biologic science degree is preferred.