Director, Device Trial Services (Hybrid)

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.

1. Strategic Leadership & Business Development (30%)

• Business Line Strategy: 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.
• Commercial Infrastructure: Define, deploy, and refine competitive pricing models, legal agreement frameworks, and standardized service offerings tailored to the specialized medical device industry.
• Sponsor & Partner Engagement: 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.
• Market Positioning: 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.

2. Operational Excellence & Execution (30%)

• Global Service Delivery: Oversee the operational and technical execution of clinical trials for medical devices across all participating Quest laboratories and partner sites.
• Cross-Functional Orchestration: 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.
• Vendor & Asset Management: Establish and manage strategic relationships with external vendors, technology providers, and specialty logistics partners to support trial operational requirements.
• Process Optimization: Continuously evaluate operational workflows to drive efficiency, maximize asset utilization, and adopt state-of-the-art trial technology.

3. Financial Ownership & P&L Management (20%)

• Financial Performance: Own the overall profitability, revenue generation, and cost management of the Device Trial Services business unit.
• Budgeting & Forecasting: Develop annual operating budgets, capital expenditure plans, and robust revenue forecasts in collaboration with Pharma Services Finance.
• Resource Allocation: Optimize resource allocation, workforce planning, and lab capacity constraints to maximize operational margins and project margins.

4. Leadership & Talent Development (20%)

• Team Building: 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.
• Capability Alignment: Define key competencies, design training frameworks, and establish performance metrics to uplevel team capabilities in device trials.
• Culture of Accountability: Foster a collaborative, inclusive, and high-performance workplace aligned with Quest Diagnostics’ core values, driving employee retention and career progression.

Required Work Experience: 

• Minimum of 8 years of progressive clinical research and development experience within the pharmaceutical, medical device, IVD, or Contract Research Organization (CRO) sectors.

Preferred Work Experience: 

• 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.

Physical and Mental Requirements: 

• Physical Requirements: Sedentary to light physical activity (sitting, computer usage), mobility for laboratory/site walk-throughs, and lifting up to 15 lbs.
• Mental Requirements: Complex data processing, high-stakes decision-making under tight deadlines, managing concurrent priority projects, and utilizing strong emotional intelligence to lead cross-functional teams and sponsor relations.

Knowledge: 

• Regulatory Competency: 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.
• Commercial & Financial Acumen: Proven experience managing P&L budgets, calculating gross margins, pricing clinical service lines, and participating in executive commercial contract negotiations.

Skills: 

• Strategic Communications: Outstanding written, verbal, and presentation skills, with a demonstrated ability to effectively communicate complex technical concepts to non-scientific executive buyers and internal stakeholders.
• Enterprise Collaboration: Highly adept at managing matrixed, cross-functional projects and driving alignment across teams without direct reporting authority.

People Leader Responsibility:

• Leads a team of 5-7 employees across IVD operations and lab support.

Work Environment:

• The work environment for this role is hybrid, combining professional office operations with active laboratory engagement.
• Travel required
• English required

Education:

• Bachelor’s degree in Life Sciences, Bioengineering, Clinical Research, or a highly related field. (Required)
• Master’s degree (MS/MBA) or Doctoral degree (PhD/MD) in Life Sciences or business administration, or equivalent professional industry experience. (Preferred)