Director, Site Operations - Biospecimen Operations

Overview

LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world.

We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions.


The Director, Site Operations – Cleveland is responsible for the management of the LabConnect Cleveland Operation and leadership of the Biospecimen Operations line of business. This includes providing oversight for all personnel and collaborating with partners to ensure operations and biospecimen requirements are adhered to; oversight of accessioning, sample processing, biorepository, and other personnel in Cleveland to ensure quality compliance, and efficient use of LabConnect systems / processes. Ensures business goal achievement, compliance with, and execution of all relevant policies and SOPs to ensure high levels of performance and client satisfaction.


Essential Duties and Responsibilities

Site Leadership

• Serves as an enthusiastic, confident, and positive leader and role model to the LabConnect Cleveland facility consistent with Company vision, mission, and values.
• Closely collaborates with LabConnect peers and leaders to ensure the facility and infrastructure (people, processes, and systems) enable repeatable, predictable process flow and operational excellence.
• Establishes appropriate performance metrics and systems.
• Communicates, coordinates, and collaborates across cross functional groups.
• Maintains a culture of trust and flexibility while maximizing productivity and quality.
• Develops and maintains KPIs aligned with corporate standards.
• Leads and develops team members while building a performance-minded culture focused on engaging and enabling the team.
• Provides strategic leadership and fosters collaboration.
• Closely collaborates with peers and leaders across the organization - establishes working relationships and drives change management.
• Develops and maintains positive, long-term, and successful relationships with key business partners including, but not limited to laboratory affiliates.
• Communicates regularly with COO and others on Company’s leadership team.

Biospecimen Operations

• Directly manages accessioning, sample processing, and biorepository personnel in Cleveland and provides leadership to non-reporting site members. Manages labor resources including accurately forecasting resource needs. Conducts performance reviews, provides training and mentoring.
• Establishes Company’s operational vision and goals including continual improvement in operational efficiency, productivity, and consistency.
• Manages client needs / issues and makes recommendations for related process enhancements and business process optimization.
• Consistently evaluates metrics, and guides actions based on metrics data to drive service quality, and profitability.
• Ensures that organizational activities and operations are carried out in compliance with local, state, and federal regulations and laws governing business operations, and with adherence to procedures and compliance.
• Maintains contact with key clients to monitor satisfaction and identify areas for improvement.
• Works with the Training Department to develop / enhance training tools. Assures training is offered and promoted for employee career development.
• Works with the leadership to support our Global Laboratory Partner program.
• Liaises with the Quality and Regulatory Services (QRS) department to ensure vendors are qualified/re-qualified and assist with issue resolution.


Education and Experience

• Bachelor’s Degree in related discipline, preferably master’s level/MBA/MS. PhD level is a plus.
• At least 10 years of related experience required, including 5-7 years in management role leading individuals in a high performing team environment, preferably in a clinical or central laboratory.
• Previous experience as a CAP Director preferred.

Skills and Ability

• Demonstrated leadership skills with broad business orientation.
• Expert operations management experience and proven track record for successful projects.
• Operations experience with budget and matrixed environment is required.
• Ability to build strong bu