Director, Device Trial Services (Hybrid)

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.

Responsibilities

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.

Qualifications

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: Sedentary to light physical activity (sitting, computer usage), mobility for laboratory/site walk-throughs, and lifting up to 15 lbs. 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)