Job Overview:
The Senior Director, IT Products, Clinical Pharmacology Services & Laboratories leads technology product management and innovation for Fortrea’s Clinical Pharmacology Services (CPS) business — its clinical research units (clinics) where participants are hosted and dosed, and its bioanalytical and clinical laboratories.
This leader owns the product strategy, roadmap, and innovation agenda for the CPS, clinic, and laboratory technology portfolio, transforming the business through automation, artificial intelligence, instrument connectivity, lab automation, and advanced analytics. The role builds the business cases and secures the funding behind that agenda, and is accountable for outcomes in participant experience, study execution, sample and data integrity, scientific throughput, quality, and client value.
The role requires genuine fluency in healthcare and regulated laboratory environments — clinic and bedside workflow, participant screening and dosing, specimen chain of custody, laboratory instrumentation and integration — with hands-on familiarity with platforms such as ClinSpark (or equivalent early-phase clinical automation systems), LIMS/LIS, ELN, CDS, and instrument middleware.
The Senior Director is also steward of this ecosystem, ensuring platforms and site infrastructure remain secure, compliant, resilient, supportable, and current. The role does not own the broader Clinical Operations technology portfolio, but partners closely with product managers and technology leaders in those areas on shared capabilities, data, integrations, and roadmaps.
Summary of Responsibilities:
- Define and execute the multi-year product strategy, roadmap, and investment priorities for technology supporting CPS, clinics, and laboratories, with clear, measurable business outcomes.
- Lead the full product lifecycle — concept, design, build or configure, validate, deploy, adopt, enhance, and retire — and establish portfolio governance for prioritization, sequencing, capacity, delivery oversight, and value realization.
- Drive innovation by identifying and prioritizing opportunities to transform business processes through automation, AI/ML, digital workflows, robotics, and advanced analytics; lead discovery, proof-of-concept, pilot, validation, and scaling of solutions that deliver measurable value.
- Champion responsible AI adoption and an environment of experimentation, rapid learning, and informed risk-taking, with governance appropriate to regulated environments; monitor market, scientific, and competitor developments for differentiation opportunities.
- Partner with operational and scientific leaders to redesign workflows rather than digitize existing ones, and balance investment across innovation, modernization, regulatory needs, and operational stability.
- Develop executive-ready business cases for major technology programs — strategic rationale, options analysis, costs, benefits, risks, and organizational impacts — supported by ROI, total cost of ownership, and scenario analysis.
- Deliver investment proposals and funding requests to senior leadership and governance boards; secure sponsorship and funding, then track and communicate realized benefits against baselines and targets.
- Own the technology product portfolio for Fortrea’s clinical research units, supporting the full participant journey from recruitment, consent, and admission through randomization and dosing, safety monitoring, discharge, and follow-up.
- Provide strategic ownership of early-phase clinical platforms such as ClinSpark — protocol build, eSource capture, barcode-driven workflows, timepoint and window management, and integration to EDC, safety, and data platforms.
- Ensure bedside and point-of-care technologies (vitals, ECG, telemetry, wearables, mobile and tablet capture, labeling and scanning) are integrated, validated, supportable, and clinically practical in 24/7, shift-based, zero-downtime dosing environments.
- Own laboratory informatics strategy — LIMS/LIS, ELN, chromatography and scientific data systems, instrument middleware, sample management, and biorepository systems — covering chain of custody, accessioning, processing, analysis, QA review, reporting, release, and retention.
- Lead instrument integration and connectivity (direct interfacing, data acquisition, bidirectional LIMS-to-instrument communication) and laboratory automation (robotic liquid handling, automated sample handling and storage, barcoding/RFID, scheduling and workcell orchestration) to increase throughput and eliminate manual transcription and error.
- Ensure laboratory and clinic systems meet GLP, GCP, GCLP, CLIA/CAP (where applicable), 21 CFR Part 11, and ALCOA+ data integrity expectations, including audit trails, electronic signatures, and instrument qualification.
- Serve as trusted technology advisor to CPS, Clinic Operations, and Laboratory leadership; translate business, clinical, scientific, and operational challenges into scalable product and technology solutions.
- Lead cross-functional transformation spanning Quality, Data, Security, Architecture, Infrastructure, Engineering, Service Delivery, Facilities, Finance, Procurement, and vendors; align with Clinical Operations product managers on shared capabilities, integrations, and data flows.
- Drive adoption and sustained business change through stakeholder engagement, communications, training, and outcome measurement; support client audits, RFPs, and bid defense as required.
- Steward the technology ecosystem so it remains secure, compliant, reliable, resilient, and current; govern operating models, product and service ownership, support structures, escalation paths, and decision rights across distributed physical sites.
- Provide oversight of technology service continuity, platform and instrument health, major incident escalation, problem management, and corrective actions; maintain visibility of application and instrument inventories, dependencies, lifecycle status, and operational risk.
- Ensure compliance with corporate policy, regulatory expectations, computerized-system lifecycle requirements, cybersecurity controls, and privacy obligations, including segmentation, patching, and monitoring of medical devices and laboratory instruments.
- Own disaster recovery strategy, recovery requirements, testing, and remediation aligned to business continuity priorities; drive remediation of technical debt, obsolescence, and vulnerabilities, and promote secure-, privacy-, compliance-, and supportability-by-design.
- Lead strategic vendor relationships — software providers, implementation partners, instrument and automation suppliers, device manufacturers, and innovation partners — including build-versus-buy and sourcing decisions and ongoing performance management.
- Manage budgets, forecasts, investment plans, resource strategies, and vendor commitments for the portfolio, optimizing spend while preserving innovation capacity, resilience, and compliance.
- Lead, coach, and develop product managers and multidisciplinary teams, including hiring, performance management, and workforce planning, in partnership with the Executive Director, Clinical Technology Platforms.
- Perform all other duties as needed or assigned.
Qualifications (Minimum Required):
- Bachelor’s degree in Information Technology, Computer Science, Engineering, Health Informatics, Life Sciences, Laboratory Science, Business Administration, or a related field.
· Fortrea may consider relevant and equivalent experience and successful project outcomes in lieu of educational requirements.
Experience (Minimum Required):
- Extensive experience in information technology, technology product management, digital transformation, clinical technology, or laboratory technology within regulated environments, including proven leadership experience.
- Demonstrated success defining and executing technology product strategy and leading automation, AI, digital transformation, or innovation programs from concept through adoption and measurable value realization.
- Demonstrated experience developing business cases, completing ROI and total cost of ownership analyses, creating executive presentations, and securing sponsorship and funding for large IT programs.
- Demonstrated experience delivering technology for physical, patient-facing provider settings — clinics, clinical research units, hospitals, or comparable care delivery sites — including on-site infrastructure, clinical devices, and 24/7 support models.
- Demonstrated experience supporting regulated laboratory environments, including laboratory informatics (LIMS/LIS, ELN, scientific data systems), instrument integration, and laboratory automation.
- Working knowledge of early-phase clinical automation platforms such as ClinSpark, or directly comparable eSource and clinic execution systems.
- Significant experience leading product portfolios, multidisciplinary teams, vendors, budgets, and complex cross-functional initiatives in global, matrixed organizations.
- Strong understanding of Clinical Pharmacology, early-phase research, clinic operations, bioanalytical laboratory operations, and scientific workflows.
- Experience with regulated computerized systems, validation, data integrity, security, privacy, change control, lifecycle management, disaster recovery, and operational support.
- Experience partnering with senior business executives and influencing decisions where priorities, funding, risk, and organizational change must be balanced.
- Demonstrated ability to pair strategic vision and innovation leadership with disciplined execution and technology ecosystem stewardship.
Preferred Qualifications Include:
- Direct experience supporting Phase I or early-phase clinical research units, GLP bioanalytical laboratories, clinical laboratories, or biorepositories.
- Hands-on experience implementing or scaling ClinSpark, LIMS/LIS, ELN, instrument middleware, or laboratory automation and robotics.
- Experience with medical device and instrument connectivity, interoperability standards (HL7, ASTM, FHIR), and OT/medical device security practices.
- Experience implementing AI, intelligent automation, advanced analytics, digital health, or robotics solutions in regulated clinical or laboratory environments.
- Relevant certifications such as PMP, SAFe, Agile, ITIL, product management, cloud, cybersecurity, laboratory informatics, or computerized-system validation.
Physical Demands / Work Environment:
Work Environment:
- Work is performed in office, home-based, clinical research unit (clinic), and laboratory environments as required.
- Periodic presence in active clinic and laboratory areas, which may include exposure to medical and laboratory equipment, controlled-access areas, cold storage, and personal protective equipment requirements.
- Regular travel to clinic and laboratory sites, with domestic and international travel based on business needs.
- On-site presence may be required during critical implementations, dosing periods, operational incidents, integration activities, audits, or business continuity events.
Physical Requirements:
- Frequently stationary for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Occasional crouching and stooping, with frequent bending and twisting of the upper body and neck.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Light to moderate lifting, carrying, or moving of objects, including luggage and a laptop computer, with a maximum lift of 15-20 lbs.
- Regular and consistent attendance.
- Varied hours may be required to support critical operations, releases, or incidents.
- Some travel, up to 25%.
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