Join the Versiti Clinical Trial Services Team

Location: Quantigen LLC, Fishers, Indiana (On-Site Only)

Employment Type: Full-Time (40+ Hours/Week)

Summary: Quantigen, part of Versiti Clinical Trials Services, is seeking an accomplished scientific leader to serve as Director of In Vitro Diagnostics (IVD). This is a high-impact role with both technical and personnel management responsibilities, requiring daily, on-site engagement to ensure effective oversight of teams and projects.

Preferred Qualifications:

• Ph.D. in molecular biology or related field and/or a minimum of 8-10 years of relevant, hands-on experience in high-complexity laboratories. Master’s Degree will be considered.
• 2-3 years of experience closely supporting IVD device development efforts, either at a biotech or pharmaceutical company.
• Both project and personnel management experience are desired, as overseeing the design and successful execution of client-based IVD projects by junior scientists and technicians is a fundamental function of this role.

Technical Qualifications:

• A solid grasp of molecular and/or protein-based techniques – qPCR, sequencing, immunoassays, etc. – and associated instrument platforms, especially those commonly used in the field of in vitro / companion diagnostics.
• A thorough understanding of how to properly design, troubleshoot, and analyze experiments for measuring the performance specifications of molecular and protein-based assays, per CLSI / FDA guidelines.
• Experience with diagnostic assay and device development under design control to FDA and IVDR-compliant procedures, including SoPs constructed around ISO13485 guidelines.
• A working knowledge of the regulatory guidelines and documentation requirements for designing and executing clinical studies supporting eventual registration of in vitro diagnostics with the U.S. Food and Drug Administration (or equivalent oversight body). Experience with companion diagnostics is considered a major plus.

Non-Technical Qualifications:

• High level of comfort managing multiple projects and their associated teams of personnel.
• Excellent communicator, capable of cogently presenting data to clients and internal stakeholders in both written and oral form.
• Ability to meaningfully contribute to the combined efforts of multiple stakeholders to capture new business and successfully execute client-based projects.

Responsibilities

• The Director of In Vitro Diagnostic Development is responsible for both the technical and scientific oversight of developed platforms, workflows, and data analysis tools into the laboratory. Besides being present at the laboratory during scheduled work hours, this individual must be accessible as needed for on-site, telephone, or electronic consultation. Responsibilities will require cooperation and communication with Quantigen management (including the Chief Scientific Officer).

Additional duties include the following:

• Oversee and direct the daily activities of all junior personnel, as well as support their professional development goals through mentorship and other activities.
• Work collaboratively with internal stakeholders – finance, business development, scientists and lab technicians, project managers, regulatory specialists, quality team, and human resources, etc. –to always deliver exceptional service and support to our clients in a timely manner.
• Communicate with prospective clients to understand and delineate new project needs, as well as to estimate T&E costs
• Ensure personnel are appropriately assigned and have documented training to work on assigned projects
• Plan experiments for ongoing projects, reviewing results, and assisting others with technical troubleshooting
• Manage day-to-day activities of junior staff, and ensure compliance with all policies and procedures
• Communicate regularly with project managers, operations lead, CSO, and other relevant stakeholders about progress and issues
• Oversee daily progress of projects from both a technical and logistical standpoint
• Write and deliver final project reports (with data summaries) for the client
• Set performance goals and write annual performance reviews on all assigned personnel.

Additional Supervisory Skills:

• Excellent communication skills for effective listening and positive body language for giving feedback to employees and customers
• Good conflict resolution skills to improve organizational productivity
• Strong leadership skills to create a supportive and motivating work environment
• Good interpersonal skills to identify and establish a purposeful team culture
• Outstanding time and priority management skills to manage intense workloads and time constraints
• Problem-solving skills to solve problems effectively and choose suitable solutions.
• Ability to motivate employees
• Understand where to draw the line between personal and professional relationships in the workplace and enforce those same standards with subordinates