Manager, R&D Operations
Eloxx Pharmaceuticals, Inc. is a clinical-stage Rare Disease biopharmaceutical company focused on restoring production of essential proteins depleted due to genetic mutations. Our library of novel drug candidates enable read-through of premature stop codons and have shown dose dependent improvements in restoring essential protein functions across multiple disease areas. Our lead investigational product candidate, ELX-02 has been granted Orphan Disease designation and is advancing to Phase 2 in Cystic Fibrosis and Cystinosis. Our recently announced Inherited retinal disease program and our partnership with the Foundation Fighting Blindness has created an opportunity to advance additional library compounds into clinical development. We anticipate continuing our rapid growth as the Company advances in clinical development, enters additional therapeutic areas and expands our pipeline.
Eloxx Pharmaceuticals (ELOX) is a Nasdaq listed biotechnology company headquartered in Boston MA with regional operations in New Jersey, Pennsylvania and Tel Aviv Israel.
Eloxx Pharmaceuticals seeks an experienced and highly motivated individual to join its R&D Operations team in Waltham, Massachusetts. The selected individual will support program management, as well as, being responsible for establishing and overseeing multiple Toxicology, DMPK and bioanalytical studies by proactive communications and study monitoring to ensure timely delivery of high-quality study results and reports at various external vendors. The individual will also liaison between internal departments and Contract Research Organizations (CRO) to confirm and track deliverables of collected samples, data and reports to ensure alignment of supporting studies is properly coordinated.
- Responsible for management, operational oversight, and on-site monitoring of nonclinical studies conducted at Contract Research Organizations
- Have overall responsibility for assuring study logistics are addressed and meet the needs of study and program team by working closely with internal scientist and CRO personnel
- Assist in requesting and delivering initial pricing for individual studies or programs for budgeting and award studies to CROs
- Work closely with project management colleagues to ensure study timelines are aligned with overall project timelines
- Provide regular updates on progress of studies and raise any issues in a timely manner
- Work closely with internal groups and CRO Labs to coordinate and track report deliverables
- Support projects through file management and document control
- Assists the preclinical program scientist in project related activities, such as maintaining vendor trackers, material shipping logistics, and drafting study related documents, as needed
- Assists in the planning and preparation for study-related meetings with internal as well as external collaborators
- Maintains meeting minutes, study tracking tools, decision logs and study calendars
- Travel to contract labs to monitor procedures on active studies as needed (up to 10%)
- Excellent communication and interpersonal skills
- Superior understanding of Microsoft Office products
- Aptitude for organizational detail and ability to manage multiple projects
- Capacity to complete tasks independently in a highly-regulated environment
- Flexibility to function well within a team environment and within condensed timelines
- Ability to verbalize complex study issues and demonstrated problem-solving ability
- Documented knowledge of regulatory requirements and good laboratory practices (GLP)
- B.S. in a relevant field with 3+ years of pharmaceutical or biotechnology experience that includes a practical understanding of the business of research and early development.
- Experience as a study monitor and/project management tools in a preclinical setting is essential
- Demonstrated understanding of GLP and regulatory requirements for the conduct of Toxicology, DMPK and Bioanalytical studies
In addition to offering competitive salaries, Eloxx Pharmaceuticals offers a full benefit package including healthcare, dental, vision, short and long-term disability, life insurance, 401(k) retirement saving plan, and paid holiday and vacation days.
Eloxx Pharmaceuticals is an Equal Opportunity Employer and does not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.