Clinical Operations Director

Mesoblast is a company with a clear sense of purpose- and the science to back it up. You will work alongside world-class scientists, clinicians, and operators who are motivated by what's at stake for patients. This is a role where clinical operations excellence is not just a function, it is the difference between a therapy reaching patients or not. This role is based full-time in our New York office (4 days on-site, 1 day WFH). Hybrid or fully remote arrangements are not available for this position but some travel may be required. About the RoleDrive clinical programs that could change the lives of patients with no other options. This is not a role for someone who wants to manage the status quo. You will own the operational delivery of a complex clinical program, drive cross-functional execution, and hold CROs and vendors to the highest standards, all while working at the frontier of regenerative medicine. You will report into Head of Clinical Development & Medical Affairs and sit at the heart of a team that cares deeply about what they do and why they do it.ResponsibilitiesLead the operational and regulatory execution of assigned clinical programs from protocol design through to final study reportsEnsure all studies are delivered on time, on budget, and in full compliance with ICH GCP, FDA requirements, and Mesoblast SOPsCoordinate across clinical monitoring, data management, biostatistics, medical writing, and safety functions to keep programs on trackAuthor and improve clinical SOPs — you will leave the function better than you found itDevelop and execute integrated cross-functional plans, risk assessments, and mitigation strategiesPrepare and manage INDs, protocols, amendments, investigator brochures, and briefing booksTrack program progress and report proactively on timelines, risks, and derailersInterface directly with regulatory authorities and agencies when requiredOversee strategic CRO partners and third-party vendors — holding them to Mesoblast's standards, KPIs, and timelinesEvaluate proposals, author task orders, and manage clinical trial budgets end-to-endBuild robust frameworks for project tracking, performance monitoring, and vendor accountabilityQualifications & Skills Bachelor's degree in a Life Science discipline; advanced degree preferred10+ years of industry experience in clinical operations, ideally with leadership exposureProven track record delivering regulated clinical trials in drug or biologics developmentStrong regulatory knowledge. FDA requirements, ICH GCP guidelines, IND experienceA natural collaborator who can influence across functions and manage upward as confidently as downwardSharp analytical instincts, rigorous attention to detail, and genuine accountability for outcomesExperience managing CROs and external vendors, including budget ownershipSomeone who thrives in a lean, fast-moving environment where your work has direct patient impactCompetitive base salary, performance-based bonuses, and long-term incentives, alongside career growth opportunities.