Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Location/Division Specific Information

Our Early Development team focuses on Phase I and IB trials which represent the first practical tests of a compound’s clinical relevance and commercial viability. They are the culmination of years or even decades of research. Moreover, they set the stage for subsequent studies that will ultimately determine your compound’s efficacy, safety and positive impact on patient’s lives.

Discover Impactful Work:

Manages a team within the Laboratory department. Processes and ships study specimens according to study protocol. Oversees department compliance with organizational policies and procedures, as well as Good Clinical Practice/ICH, GDP, OSHA and CIA or CLIA-waived guidelines and local regulatory guidelines.

A day in the Life:Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.Forecasts and manages all functions of the early phase clinical and PK Laboratory. Contributes to the development and maintenance of procedures and policies to support optimization of operations. Projects staffing requirements. Assures that the training needs and requirements of laboratory are met.Arranges and projects the activities, methods and procedures of the sample collection to ensure proper specimen integrity and shipping are successfully attained. Plans the development, implementation and continuous monitoring of a quality improvement plan for the group.

Keys to Success:

Education and Experience: 

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) or equivalent and relevant combination of education, training, & experience.1+ year of leadership responsibility

Knowledge, Skills, AbilitiesGood knowledge of CLIA, CAP and FDA regulationsStrong leadership skills, including ability to motivate, mentor and trainAdvanced written and verbal communication skillsStrong time management, organizational and multi-tasking skillsSolid critical thinking, problem-solving and troubleshooting skillsProficient in Microsoft Office products Ability to work in a collaborative team environment Strong knowledge of operational laboratory instrumentationGood knowledge of special handling and processing of specimensAdvanced knowledge of operating laboratory instrumentationGood understanding of budgeting and forecasting with the ability to interpret data with attention to detail and analytical and investigative skillsCapable of driving innovation in developing new ideas related to process improvementsExcellent communication skills with Czech and English