Managing Director, Laboratory Operations

Reposted 4 Days Ago
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Portland, OR, USA
In-Office
Expert/Leader
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Role
Oversee ICON's Specialty Laboratory Operations, managing all aspects of high-complexity testing, ensuring compliance, and delivering operational excellence while also overseeing P&L responsibilities.
Summary Generated by Built In
Managing Director, Speciality Lab Operations - Portland, Oregon - Onsite

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

ICON Specialty Labs partners with biopharma clients to design, verify and validate clinical trial assays (CTA) for patient selection, therapeutic efficacy, and monitoring. We are at the forefront of precision medicine diagnostic technology and ensure reliable and accurate results for pivotal clinical end points.

ICON Specialty Lab's distinction is premised on the fact that diagnostic strategies and challenges for each therapeutic program are unique and often change course with limited notice. The ideal diagnostic partner needs to excel in technical, clinical, quality, regulatory and commercial competencies while collaboratively planning and navigating the translational, clinical, and commercial phases of the therapeutic program. 

The Managing Director, Laboratory Operations role will be responsible for the overall success, quality and profitability of the ICON Lab in Portland, Oregon. They will oversee and manage all aspects across high‑complexity testing in our Specialty Laboratory Operations (in collaboration with the Medical Director) including but not limited to: Sample Receipt & Processing, Clinical Trial Testing & Reporting, Custom Method Development, Reagent Production, Project Management, Record Retention, Regulatory Compliance (CLIA, CAP, NY & other states, FDA, EMA, etc.), Inventory Management and Employee Safety.  They will have direct P&L responsibilities while managing a team of Directors and Managers. This role drives strategic growth, operational excellence, and innovation while ensuring compliant, high‑quality delivery of specialty laboratory services supporting global clinical trials.

Primary Responsibilities:

  • Provide strategic and operational leadership for global Specialty Laboratory Operations.

  • Ensure compliance with CAP, CLIA, NYS, and applicable global regulatory requirements.

  • Own operational performance metrics, including quality, turnaround time, productivity, and cost efficiency.

  • Maintain financial accountability, including budgeting, forecasting, and investment planning.

  • Lead and develop senior laboratory leadership teams; drive talent development and succession planning.

  • Partner cross‑functionally with Medical, Quality, Commercial, IT/LIMS, and Global Lab Operations.

  • Sponsor automation, digital, and process improvement initiatives to support scalability and innovation.

Position Requirements:

  • 10 years progressive experience including both CAP/ CLIA accredited and GLP Lab environments, including at least 5 years experience in these environments managing P&L

  • Proven ability to effectively communicate with external clients, especially in support of increasing revenue attainment

  • BS or higher Degree in Medical or Life Sciences (clinical, biological, chemical, or laboratory science discipline) required; MBA preferred

  • Proven ability to successfully lead, motivate and influence employees positioned at all organizational levels including change leadership

  • Strong interpersonal, analytical and communication skills

  • Able to be in the Portland, Oregon office 5 days a week
     

#LI-LE1

#LI-Onsite

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

  • Various annual leave entitlements

  • A range of health insurance offerings to suit you and your family’s needs.

  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.

  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.

  • Life assurance

  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply

Top Skills

Cap
Clia
Laboratory Management
Medical Or Life Sciences
P&L
Quality Assurance
Regulatory Compliance
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The Company
HQ: Dublin
34,685 Employees
Year Founded: 1990

What We Do

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.

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