Clinical Director, Laboratory Services (onsite Bilbao - Spain) - Level depending on experience

CTI; País Vasco; Presencial; EUR 100.000 - 140.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work opportunities

CTI Cares program

Descripción de la vacante

CTI is seeking a Laboratory Director in Bilbao, Spain to provide scientific direction for safety and specialty testing. You will ensure standardized processes, regulatory readiness, and staff qualifications across hematology, chemistry, immunoassays, flow cytometry, and molecular testing.

You will lead a cross-disciplinary team, drive quality systems, manage LIMS, and liaise with sponsors and regulators to advance clinical diagnostics globally.

Formación

• Fluent in English.
• Local Bilbao Spain Laboratory Director requirements.
• CAP director license requirements: PharmD/PhD or MD/DO with specified credentials and experience.
• Minimum 5 years leadership across multiple clinical disciplines.

Responsabilidades

• Provide scientific direction and oversight for Bilbao laboratory safety and testing.
• Develop and ensure compliance of standardized processes for the central lab.
• Ensure staff qualification and licensing as required.
• Design, validate, and maintain accuracy of laboratory tests.
• Monitor laboratory work to ensure clinically reliable data.
• Advise sponsors/clients on lab findings significance.
• Serve as SME for client interactions and business development.
• Act as operations representative for regulatory interactions (FDA/CLIA/CAP/EMA/ISO, IVDR).
• Oversee lab documentation for inspection readiness.
• Lead development and improvement of laboratory quality system.
• Review and approve policies, validation plans/reports, training and competency assessments.
• Participate in partner lab selection.
• Report test quality/safety concerns to Clinical Director.
• Support IT/LIMS implementation with IT and Lab Leadership.
• Provide ongoing education to staff.

Conocimientos

Fluent in English

5+ years leadership in clinical lab

Multidisciplinary lab leadership

Educación

PharmD or PhD in chemical/biological/clinical lab science with Clinical Analysis or Clinical Biochemistry specialization, EU equivalent

MD or DO with board certifications in anatomic or clinical pathology

MD or DO with 1 year residency training or 2 years supervising high-complexity testing

Descripción del empleo

WhatYou’llDo:

• Laboratory Oversight & Administrative
  • Provide effective and efficient scientific direction and oversight for the Bilbao laboratory safety and specialty testing (hematology, chemistry, immunoassays, flow cytometry, molecular…)
  • Ensure the development, implementation, and compliance of standardized processes for CTI central lab
  • Ensure that technical staff are qualified, and licensed as required, to perform and supervise all testing and has met training and/or competency requirements
  • Responsible for designing, validating, and maintaining the technical accuracy and medical reliability of the laboratory tests
  • Monitor all work performed in the laboratory to ensure that clinically reliable data are generated and efficiently reported
  • Provide advice to sponsors and clients regarding the significance of laboratory findings
  • Subject Matter Expert for client interactions and business development activities
  • Act as operations representative for regulatory interactions that include FDA/CLIA/CAP/EMA/ISO, IVDR, etc
  • Oversee and maintain relevant laboratory documentation to ensure inspection readiness
  • Lead the development and continuous improvement of laboratory quality system and ensure adherence to established processes and plans
  • Review and approve laboratory documentation such as policies and procedures, validation plans and reports, training and competency assessments and nonconforming event reports
  • Participate in the selection of partner laboratories
  • Report all concerns of test quality and/or safety to Clinical Director, Global Laboratory Services
• Laboratory Quality Management System (QMS)
  • Working with Quality Assurance to support and enforce all aspects of the laboratory’s QMS to ensure conformance to requirements described in the Quality Management System and Clinical Laboratory Practice Standards
  • Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of services provided
  • Ensure that the laboratory participates in monitoring and evaluating the quality assurance program by adhering to required regulatory activities
  • Ensure that the laboratory is enrolled in the appropriate proficiency testing program for the testing performed
  • Effectively implement corrective action plans to deficiencies identified
• Laboratory Information Management System (LIMS)
  • Work with IT and Lab Leadership in implementation and management of the LIMS
• Personnel Management
  • Ensure that policies and procedures are established for monitoring staff to assess competency, and whenever necessary, provide remedial training or continuing education to improve skills
  • Provide continuing education to laboratory technical staff that is relevant to laboratory medicine

WhatYou’llBring:

• Fluent in English
• Local requirements to serve as Laboratory Director in Bilbao, Spain
• License requirements to serve as a CAP (College of American Pathologists) laboratory director for international labs:
  • PharmD or PhD in a chemical, biological, or clinical laboratory science with specialization in Clinical Analysis (Análisis Clínicos) or Clinical Biochemistry (Bioquímica Clínica), or EU equivalent (e.g Clinical Biologist), recognized by the Spanish Ministry of Health, AND 2 years of clinical laboratory experience directing/supervising high complexity testing
  • MD or DO licensed to practice in the jurisdiction with board certifications in anatomic or clinical pathology, or
  • MD or DO licensed to practice in the jurisdiction with 1 year clinical laboratory training during residency or 2 years of experience supervising high complexity testing in a clinical laboratory
• At least 5 years’ experience as a Clinical Laboratory leader with previous experience across multiple clinical disciplines

AboutCTI

• AdvanceYourCareer–Weinvestinyourprofessionalgrowth.Ourstructuredmentoringprogram,leadershipdevelopmentcourses,anddedicatedtrainingdepartmentprovidethesupportyouneedtoexcel.Wealsoencourageongoingeducationtohelpyouachieveyourprofessionalgoals.
• JoinanAward-WinningTeam–Joinaglobalteamspanning60countries,recognizedforitsaward-winningculturethatprioritizespeople.Wesupportyourwork-lifebalancewithhybridworkopportunities.ThroughourCTICaresprogram,you’llhaveopportunitiestogivebacktoyourcommunityandtheworld.
• MakeaLastingImpact–AtCTI,yourworkdirectlycontributestoadvancingmedicine.You’llplayavitalroleindevelopinglife-changingtreatmentsforpatientswithchronicandcriticalillnesses.Together,wemovemedicineforward,makingadifferenceforthosewhoneeditmost.