The Director, Clinical Operations will be responsible for providing clinical operations leadership and perspective in defining the Clinical Operations organization and overseeing its processes and execution of clinical study programs. He/she will work in close collaboration with Luminex Research Departments, Regulatory Affairs, Scientific Affairs and Sales & Marketing to ensure effective and efficient conduct of clinical research activities in accordance with applicable regulations and standards (e.g. 21 CFR Part 812, CLSI, ICH) that demonstrate the performance and utility of in vitro diagnostic products.What you will doDirect and manage a group of clinical associates and managers and oversee the Clinical Operations Laboratory activities in accordance with GCP and Corporate Mandates relating to clinical trial schedules.Establish effective clinical study schedules to ensure timely progress of multiple products through clinical benchmarking and validation studies.Oversee clinical study logistics, equipment’s, schedules and resource allocationsOversee the maintenance and management of CTMS (Clinical Trial Management Software) administrationWrite and/or review clinical operations SOPsMaintain awareness of current advances in clinical research and literature (including regulations and standards) pertaining to in vitro diagnostic devices to ensure clinical development plans and study protocols capture all relevant considerationsProvide leadership within Clinical Affairs and across Luminex departments aimed at maintaining a corporate culture that fosters collaboration and communicationInteract with Research, Assay Development, Regulatory, Operations and Marketing and Sales to efficiently and effectively manage clinical validation, transfer and launch of a portfolio of diagnostic productsPrepare departmental budgets and establish external resources (service providers / CROs) and internal resources (personnel time allocation) needed for each clinical programOther duties as assigned.Education QualificationsMaster's Degree Molecular Biology / Biochemistry or related discipline with at least 10 years’ experience in a regulated clinical research environment. requiredPh.D. Molecular Biology/Biochemistry with at least 5 year related experience preferredExperience Qualifications8 Years Experience managing clinical trials required5 Years Training & work experience in document and record management for clinical study (GCP) required5 Years GCP/GLP, GMP and/or FDA regulated environment required4 Years Significant experience leading and managing a team of scientists and associates on a day-to-day basis required3 Years Experience preparing and working within budgets preferred3 Years People management experience requiredTraining and SkillsAbility to advance projects through to completion, meeting key milestones (High proficiency)Demonstrates good judgment and good decision-making, sometimes quickly and with limited information available (High proficiency)Capacity to manage several projects in parallel to ensure maximum productivity, without compromising quality, in pipeline development (High proficiency)Superior communication and technical writing skills (High proficiency)Standard Working ConditionsMust work onsite at Luminex office 60%-100% of the time - OccasionallyPossible exposure to biological or chemical hazard, extensive noise, and/or working with lasers - RarelyWork situations include dealing with people; working alone; making judgments and decisions; and directing, controlling or planning the activity of others - Frequentlyo Vision (Color) on the job is required occasionally - FrequentlyTravel Requirements20% Travel internationally and domestically