Currently hiring for a Sr. Director of Laboratory Operations with a CRO looking for individuals with CRO and Diagnostic industry experience.
*Relocation Assistance is Offered
Responsibilities:
- Lead the daily operations of the laboratory division within the Clinical and Biopharma Business Solutions, ensuring alignment with senior management’s objectives.
- Create and implement policies, procedures, and best practices to boost efficiency, quality, and productivity in laboratory operations.
- Develop and execute operational plans aimed at achieving business targets and driving growth. Foster innovation to improve laboratory processes.
- Oversee and coordinate work across lab teams to ensure timely and accurate delivery of results.
- Identify and implement changes to enhance workflow processes, ensuring exceptional customer service.
- Work closely with IT to prioritize and implement software enhancements that support internal operations and customer needs.
- Partner with lab, project management, and commercial teams to ensure cohesive operations and project success.
- Provide regular updates on project status, quality metrics, and general feedback to senior laboratory leadership.
- Develop and manage operational budgets for the division, monitoring financial performance and implementing cost-effective measures.
- Assist in planning and overseeing expansions of CLIA lab facilities.
- Build and maintain strong relationships with clients, partners, and stakeholders. Manage external relationships and address issues affecting the CRO business.
- Collaborate with laboratory staff, project management, and clients to resolve operational or technical issues.
- Act as the primary point of contact between the labs and project management within the company.
- Prepare for and lead the transition to FDA oversight of Lab Developed Tests.
- Oversee the implementation of IT initiatives, including LIMS (Laboratory Information Management Systems).
Qualifications:
- Bachelor’s degree in a related field required; advanced degree (MBA, MS, PhD) preferred.
- At least 10 years of experience in clinical lab and CRO operations development and strategic planning, with a minimum of 5 years in a management role.
- Strong expertise in molecular biology and laboratory practices (CLIA, CAP).
- Ability to rapidly learn and integrate new technologies.
- Proactive approach to problem-solving with strong decision-making abilities.
- Proven track record of completing projects within scope and timeline.
- Superior analytical, interpersonal, and problem-solving skills, with professional verbal and written communication abilities.
Preferred Skills:
- Experience with Lean methodologies to enhance operational efficiency.
- Lead Six Sigma projects to achieve measurable improvements. Black Belt certification is a plus, with the ability to train and mentor staff in Six Sigma practices.
