Director, Biotransformation - Hybrid

JOB OVERVIEW

Oversee, guide, perform and interpret in vitro and in vivo biotransformation studies. Provide direction and supervision to a designated group of scientific staff to ensure projects are resourced appropriately and employees are trained to meet project needs. Work with staff to ensure all project deliverables are completed to the sponsor’s satisfaction and in accordance with all applicable standard practices and policies. Assist in formulating effective strategic goals and objectives, assure implementation and operational integration of those goals. Assume ownership of strategic initiatives and work with other functional management to develop implementation plans, including measures to evaluate success. May also serve as project manager, as required. Oversee study execution as it relates to timelines, data quality, and interpretation of results. Establish relationships with clients.

RESPONSIBILITIES

• Manage staff in accordance with organization’s policies and applicable regulations.
• Responsibilities include planning, assigning, and directing work, appraising performance, and guiding professional development, rewarding, and disciplining employees, addressing employee relations issues and resolving problems.
• Approve actions on human resource matters.
• Functional area technical expert in metID concepts, including instrumentation, study design, conduct and data interpretation.
• Design, interpret, implement, document, report, and oversee metID study packages in collaboration with biotransformation staff, including analytical methods for analysis of metabolites, metabolic profiling, and MS and MS/MS data collection, using appropriate level of regulatory compliance.
• Troubleshoot and/or consult on more complex metID packages, including analytical method, metabolite profiling, metabolite identification, and broader study impact.
• Interpret MS/MS data and assign metabolite structures, mentor staff on metabolite assignments.
• Coach and mentor employees around project planning, project review, and problem solving to ensure alignment of work practices across the team through the adoption and use of all process and technology tools.
• Obtain and provide regular feedback to employees from customers and key stakeholders to assist in personal and professional development.
• Identify skill and competency gaps at the individual level and work to craft development plans that will close those gaps.
• Take a strong leadership role in exploring and evaluating new technologies with a focus on efficiency and value for the customer.
• Work with staff to identify efficiency gains through process improvements and/or technological advances.
• Take a leadership role within the management team to proactively identify project and/or individual needs and resourcing solutions in order to manage project issues and obstacles.
• Provide scientific oversight/review for cross-disciplinary Discovery/Metabolism Services Group efforts.
• Consult on scientific strategy of broader Discovery/Metabolism Services Group, consulting on study/package design, reviewing cross-group work products, resolving complex scientific problems, and communicating with clients on broader Discovery/Metabolism Services issues.
• Propose, manage, and implement scientific initiatives and/or strategies in consultation with management.
• Oversee the performance of tasks associated with the execution of project work to Quintiles’ scientific standards and to the complete satisfaction of the customer.
• Consult with clients to prepare relevant drug metabolism sections of global dossiers for regulatory submissions.
• Oversee the design, interpretation, validation, troubleshooting, implementation, documentation, and reporting, of all project work using appropriate level of regulatory compliance.
• Collaborate with clients, external Quintiles divisions, third-party vendors, and Discovery/Metabolism Services staff on scientific issues for complex projects, scientific principles, and regulatory gap analyses.
• Manage allocation of resources with an eye towards efficiency and quality, including project assignment and capacity management.
• Provide direction, support, and policy development recommendations to assigned staff and Quintiles management team, as requested by Quintiles management.
• Be an active and visible participant in the field of Discovery/Metabolism Services.
• Keep abreast of literature, interact with peers in the discovery and metabolism scientific arena, attend professional meetings being vigilant for publication/presentation opportunities.
• Keep abreast of new technologies, techniques, study designs or equipment.
• Participate in proposal development for Discovery/Metabolism Services business proposals.
• Participate in business development for Discove