Director, Device Trial Services (Hybrid)

Quest Diagnostics•Lewisville, TX

14h•Hybrid

About The Position

The Director, Device Trial Services is a key leadership role responsible for the strategic planning, commercial positioning, and operational execution of Quest Diagnostics’ clinical trial services for medical devices and In Vitro Diagnostics (IVD). This leader is tasked with building and scaling a high-performing business unit from the ground up, establishing robust infrastructure, pricing models, and service offerings that span the global Quest network. Acting as the primary internal and external leader for this business line, the Director connects and drives alignment across multi-disciplinary enterprise functions (R&D, Finance, Legal, Quality, Sales, and Lab Operations) while directly cultivating executive-level relationships with sponsors, contract research organizations (CROs), and key healthcare industry partners.

Requirements

Minimum of 8 years of progressive clinical research and development experience within the pharmaceutical, medical device, IVD, or Contract Research Organization (CRO) sectors.
Deep understanding of global medical device/IVD clinical trial regulatory standards, including FDA 21 CFR, ISO 14155, GCP, ICH guidelines, and European IVDR/MDR regulations.
Proven experience managing P&L budgets, calculating gross margins, pricing clinical service lines, and participating in executive commercial contract negotiations.
Outstanding written, verbal, and presentation skills, with a demonstrated ability to effectively communicate complex technical concepts to non-scientific executive buyers and internal stakeholders.
Highly adept at managing matrixed, cross-functional projects and driving alignment across teams without direct reporting authority.
Bachelor’s degree in Life Sciences, Bioengineering, Clinical Research, or a highly related field. (Required)

Nice To Haves

5+ years of direct experience in medical device/IVD trial design, development, and commercial execution, with at least 3 years in a dedicated people management or enterprise leadership capacity.
Master’s degree (MS/MBA) or Doctoral degree (PhD/MD) in Life Sciences or business administration, or equivalent professional industry experience. (Preferred)

Responsibilities

Build and execute the multi-year growth strategy, operating model, and commercial roadmap for Device Trial Services to establish Quest Diagnostics as a market leader in medical device and IVD trials.
Define, deploy, and refine competitive pricing models, legal agreement frameworks, and standardized service offerings tailored to the specialized medical device industry.
Partner closely with Pharma Services Business Development to lead executive-level client interactions, act as the clinical and operational Subject Matter Expert (SME), and craft tailored clinical trial solutions to win new business.
Maintain an in-depth understanding of market trends, regulatory landscapes (e.g., FDA, IVDR/MDR), and competitor actions to continually adjust Quest’s service offerings.
Oversee the operational and technical execution of clinical trials for medical devices across all participating Quest laboratories and partner sites.
Manage matrixed processes and serve as the main escalation and integration point across R&D, Commercial Operations, Legal, Quality Assurance, and Laboratory Operations to ensure flawless study execution.
Establish and manage strategic relationships with external vendors, technology providers, and specialty logistics partners to support trial operational requirements.
Continuously evaluate operational workflows to drive efficiency, maximize asset utilization, and adopt state-of-the-art trial technology.
Own the overall profitability, revenue generation, and cost management of the Device Trial Services business unit.
Develop annual operating budgets, capital expenditure plans, and robust revenue forecasts in collaboration with Pharma Services Finance.
Optimize resource allocation, workforce planning, and lab capacity constraints to maximize operational margins and project margins.
Build, organize, and manage a high-performing, cross-functional team, including Clinical Trial Study Managers and administrative personnel, while providing operational oversight to associated Diagnostics Development laboratory personnel.
Define key competencies, design training frameworks, and establish performance metrics to uplevel team capabilities in device trials.
Foster a collaborative, inclusive, and high-performance workplace aligned with Quest Diagnostics’ core values, driving employee retention and career progression.