Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Provides oversight to one or more sites, departments or regions in global Labs. Integrates operational processes, business development, research & development and quality assurance functions for optimal performance within the labs. Provides leadership in protocol consultation and laboratory testing for multiple therapeutic areas. Contributes to the scientific strategy and implementation to support pharmaceutical-sponsored research protocols.

Essential Functions:

Evaluates, develops, implements and validates new analytical methodologies to provide integrated solutions and clinical trial expertise to clients. Partners with third-party laboratories for tests not performed in-house.Serves as primary laboratory interface with sponsors and clinical investigators. Assists sponsors with protocol development and participates in investigator meetings as a scientific expert.Performs financial analyses to improve cost efficiency of laboratory operations. Manages and controls budgets for cost expense reduction. Provides business updates to senior leadership.Sets operational standards/goals and directs the implementation of laboratory goals and policies. Oversees resource allocation including space, capital equipment and scientific instrumentation.Identifies staffing needs to ensure the laboratory is staffed with qualified personnel. Manages laboratory performance and ensures proper training.Defines, implements and monitors standards of performance in quality control and quality assurance. Ensures consistent harmonization of assays across laboratories.

Qualifications:
Education and Experience:
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12+ years) or equivalent and relevant combination of education, training, & experience.
8+ years of business management responsibilities.

Knowledge, Skills and Abilities:

Broad knowledge of bioanalytical laboratory operations for pharmaceutical and biotech industriesIn-depth knowledge of clinical laboratory science, GMP, FDA regulations concerning clinical labs processes in drug development process, method development, method validation, R&D, sample production and data processingExcellent communication/interpersonal skills including presentation skillsIn-depth knowledge of budgeting, forecasting and fiscal managementDemonstrated strategic planning skillsIn-depth global and cultural awarenessStrong organizational agility and demonstrated drive for resultsExcellent coaching and mentoring skillsExcellent marketing and negotiation skills