Associate Director, Specimen Management – Lab Start-Up

MSD

Associate Director leading specimen management and lab start-up for clinical trials in the biopharmaceutical sector. Overseeing laboratory operations and team collaboration for successful study execution.

Posted 7/29/2026full-timeRemote • New Jersey, Pennsylvania • 🇺🇸 United StatesSenior💰 $142,400 - $224,100 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in laboratory and specimen management, ensuring compliance with Good Clinical Practice (GCP) and applicable GxP requirements while leading cross-functional teams to optimize study start-up processes and operational efficiency.

Highest-signal resume keywords

Specimen Lifecycle ManagementClinical Development Best PracticesCross-Functional Team LeadershipAnalytical SkillsMicrosoft Office Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Specimen AnalysisLaboratory Manual DevelopmentQuality Improvement InitiativesRoot Cause AnalysisPerformance Indicator Development

Soft Skills

Interpersonal SkillsNegotiation SkillsWritten Communication SkillsOral Communication SkillsTeamwork

Tools & Technologies

Biorepository SystemsMicrosoft ExcelMicrosoft PowerPoint

Industry Keywords

Good Clinical Practice (GCP)GxP RequirementsIATA/DOT Shipping RegulationsClinical TrialsBiopharmaceutical Industry

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead laboratory and specimen management activities during study start-up for assigned clinical trials or programs
Review study protocols to assess specimen collection, processing, storage, shipment, and testing requirements
Oversee development and review of laboratory manuals, specimen collection guidelines, requisition forms, and related study documents
Coordinate central laboratory, specialty laboratory, and provider set-up activities to ensure operational readiness prior to site activation
Partner with study teams to align laboratory timelines with broader study start-up milestones
Identify study risks related to specimen handling or lab operations and implement mitigation plans
Oversee end-to-end specimen lifecycle management processes, including: collection requirements, processing workflows, packaging and shipment, chain of custody, sample tracking, reconciliation, and discrepancy management
Ensure specimen operations are executed in accordance with protocol, our expectations, and internal standards
Monitor sample-related metrics, quality issues, and trends to drive timely issue resolution and performance improvement
Provide escalation support for specimen-related operational issues that may impact sites, laboratories, or study timelines
Manage relationships with central laboratories, specialty laboratories, courier/logistics providers, and kit providers
Support provider selection, feasibility assessments, scope review, and operational planning
Oversee provider performance against service level agreements (SLAs), turnaround times, quality expectations, and study deliverables
Facilitate provider governance meetings, performance reviews, and issue escalation/resolution
Ensure external partners are aligned with protocol-specific sample handling requirements and study timelines
Collaborate closely with Clinical Operations, Biomarker Managers, Pharmacokinetics, Data Management, Regional teams, Quality, and other internal stakeholders to support seamless study execution
Act as the subject matter expert for specimen management and lab start-up processes during study planning and execution
Provide recommendations on protocol feasibility and operational design related to specimen collection and laboratory workflows
Communicate study risks, readiness status, and key specimen management updates to internal and external stakeholders
Ensure specimen management and lab start-up activities comply with: Good Clinical Practice (GCP), Applicable GxP requirements, IATA/DOT shipping regulations, internal SOPs and quality standards
Maintain inspection readiness for laboratory and specimen-related processes
Support deviation investigations, root cause analysis, corrective and preventive actions (CAPA), and quality improvement initiatives
Promote consistent documentation practices and operational compliance across studies and teams
Provide day-to-day leadership, coaching, and guidance to specialists, senior specialists, and/or managers supporting specimen management and lab start-up activities
Assist with workload planning, prioritization, and resource coordination across assigned studies or programs
Contribute to staff development, training, onboarding, and performance feedback
Foster a collaborative, accountable, and continuous-improvement-focused team culture
Evaluate existing specimen management and start-up processes to identify opportunities for improvement, standardization, and scalability
Support implementation of new technologies, tools, and workflows to improve specimen visibility, tracking, and operational efficiency
Develop and report key performance indicators (KPIs) related to study start-up readiness, sample quality, reconciliation, and provider performance
Lead or contribute to strategic initiatives to improve site experience, data quality, and operational execution

Requirements

What you’ll need

Minimum of 5 years in laboratory, biopharmaceutical and/or the supplier industry
Strong interpersonal skills including cross-functional teamwork, and written and oral communication skills
negotiation skills
exceptional analytical skills
multi-cultural skills
high energy level, and a bias toward action
Ability to oversee specimen analysis and effectively summarize and present insights
Solid understanding of clinical development and operations best practices
Microsoft office skilled (e.g., excel and power point)
Biorepository system background

Benefits

Comp & perks

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays, vacation, and compassionate and sick days