Clinical Operations Manager

Company OverviewFounded in 2017, Eton is an innovative pharmaceutical company focused on developing, acquiring, and commercializing high-potential therapies for the treatment of patients with rare diseases. We take pride in helping rare disease patients overcome unthinkable challenges to live up to their greatest potential. Eton currently has twelve commercial rare disease products: KHINDIVI ®, INCRELEX®, ALKINDI SPRINKLE®, DESMODA™, GALZIN®, HEMANGEOL®, PKU GOLIKE®, IMPAVIDO®, LIBERVANT®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has five additional product candidates in late-stage development: ASN-001, AMGLIDIA®, ET-700, ET-800, and ZENEO® hydrocortisone autoinjector.CLINICAL OPERATIONS MANAGER Job DescriptionEton is seeking a Clinical Operations Manager to oversee the planning and execution of clinical studies supporting our pharmaceutical development programs. This role will manage day-to-day clinical operations, CROs and vendors, study timelines, budgets, and regulatory compliance.The position reports to the Executive Director of R&D and works closely with Regulatory Affairs, Quality, Medical Affairs, and external partners.

Responsibilities

Manage clinical studies from start-up through completion, ensuring adherence to timelines, budgets, protocols, and Good Clinical Practice (GCP).Oversee CROs, clinical sites, and vendors, including performance, deliverables, contracts, and budgets.Coordinate site selection, activation, patient enrollment, monitoring, and study closeout activities.Ensure compliance with applicable regulations, GCP, and internal procedures, including appropriate sponsor oversight and participant safety.Maintain clinical study documentation, trial master files, and inspection readiness.Collaborate with Regulatory Affairs on clinical submissions, regulatory commitments, and study-related documentation.Coordinate with cross-functional teams on clinical supplies, safety reporting, data management, and study deliverables.Track study progress, identify risks, implement corrective actions, and provide regular updates to leadership.Support improvements to clinical operations processes and procedures.

Qualifications

Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related field; advanced degree preferred.5–7 years of clinical research or clinical operations experience in the pharmaceutical, biotechnology, or CRO industry.At least 2 years of clinical study management experience.Experience overseeing CROs, clinical sites, study budgets, timelines, and vendors.Strong understanding of GCP, clinical trial regulations, and sponsor responsibilities.Familiarity with clinical trial management systems, electronic data capture, and trial master files.Strong project management, communication, organizational, and problem-solving skills.Ability to work independently and manage multiple projects in a fast-paced environment.Experience with rare disease or pediatric clinical trials preferred.

What We Offer

The anticipated annual base salary range for this position is $130,000 to $170,000. Final pay determinations will depend on various factors such as geographical location, experience level, knowledge, skills, and abilities. In addition to base salary, this position is eligible for an annual performance-based bonus, equity compensation, and a comprehensive benefits package.Eton offers excellent benefits including:Competitive medical, dental, and vision coverage401K matchEton-paid Life, LTD and STD insurance coveragesGenerous paid time off including vacation, sick time, and holidaysOpportunities for equity grantsAbility to participate in employee stock purchase program