Senior Director, Biospecimen Management

Jobtailor; Princeton (NJ); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Jobtailor seeks a senior leader to build and direct a biospecimen management function across a portfolio of 100+ clinical studies. You will steer on-site and remote teams, ensure high-quality specimen handling, and integrate regulatory guidance throughout development from pre-clinical to clinical trials.

You will drive vendor relationships, optimize processes, and maintain strong cross-functional collaboration, all while upholding GCP/ICH standards across global operations.

Qualifications

• Bachelor's degree in a relevant scientific discipline is required.
• 10+ years of global experience in clinical drug development with biospecimen management exposure.
• 7+ years of leadership experience managing global, cross-functional teams.
• Extensive drug development experience from pre-clinical through clinical testing with regulatory and ethical focus.
• Experience with central laboratories, data management, and clinical operations organizations.
• Proven ability to manage vendor relationships in biospecimen management.

Responsibilities

• Lead and develop a high-performing biospecimen management team with accountability for performance and growth.
• Oversee biospecimen management leads supporting trials across therapeutic areas.
• Lead distributed on-site and remote teams.
• Drive high-quality and efficient biospecimen management across the trial portfolio.
• Serve as escalation point for study- and portfolio-level biospecimen risks and issues.
• Define, track, and report KPIs for biospecimen management capacity and effectiveness.
• Partner with leadership on strategic planning, process improvement, and service development.
• Lead initiatives to advance operational quality and introduce new capabilities.

Skills

Leadership

Global team management

Project management

Communication

Negotiation

Detail-oriented

Cross-functional collaboration

Operations optimization

Education

Bachelor's degree in relevant scientific discipline

Master's or Doctoral degree (preferred)

Tools

Biospecimen Management Systems

Chain-of-Custody Tracking Technologies

Data management interfaces

Job description

• • Lead and develop a high-performing Biospecimen Management team, with accountability for performance, career growth, and talent development
• • Oversee biospecimen management leads supporting trials across all therapeutic areas
• • Lead geographically distributed on-site and remote teams
• • Drive high-quality, efficient biospecimen management across the BMS clinical trial portfolio
• • Serve as the primary escalation point for study- and portfolio-level biospecimen collection risks and issues
• • Manage internal timelines aligned with vendor and clinical study milestones
• • Resolve or escape vendor issues
• • Define, track, and report key performance metrics for biospecimen management capacity and operational effectiveness
• • Partner with CBI leadership on strategic planning, process improvement, and service development
• • Lead initiatives to advance operational quality, close gaps, and introduce new capabilities
• • Lead cross-functional innovation and improvement of biospecimen operations at scale
• • Contribute to IT capabilities for operational effectiveness, biospecimen tracking, and reconciliation
• • Build and sustain partnerships across a diverse stakeholder network
• • Manage and develop biospecimen management vendor relationships and performance standards
• • Serve as a functional subject matter expert during internal audits and vendor visits
• • Maintain knowledge of regulatory guidance, GCP/ICH standards, and industry trends
• • Apply scientific knowledge of safety, pharmacokinetics, genetics, and biomarker research to optimize processing and sampling plans
• • Ensure regulatory and ethical aspects of biospecimen collection are embedded in operational processes
• • Ensure resourcing and capacity planning across a portfolio of 100+ clinical studies
• • Apply project prioritization, financial planning, and portfolio management skills to deliver operational objectives

Requirements

• Bachelor's degree in a relevant scientific or clinical discipline (required)
• 10+ years of global experience in clinical drug development, clinical research, or a related field, with biospecimen management experience required
• 7+ years of leadership experience managing global, cross-functional teams
• Extensive drug development experience from pre-clinical through clinical testing, emphasizing operational, regulatory, and ethical dimensions of biospecimen collection
• Demonstrated experience working with central laboratories, data management, and clinical trial operations organizations
• Prior experience with corporate drug development and submissions, particularly in clinical development and translational medicine
• Experience managing and developing relationships with biospecimen management vendors
• Advanced knowledge of GCP/ICH guidelines, biospecimen management systems, and clinical development processes
• Familiarity with chain-of-custody tracking technologies and biospecimen management tools
• Ability to translate scientific and regulatory requirements into technology builds enabling digitization of biospecimen operations
• Strong project management, resource planning, and financial management capabilities
• Ability to lead large, diverse, global teams across multiple time zones and therapeutic areas
• Outstanding communication, negotiation, and influencing skills
• Proven ability to build cross-functional relationships and foster positive team dynamics
• Highly detail-oriented, able to manage multiple priorities and complex portfolios simultaneously
• Excellent oral and written communication skills
• Up to 20% travel
• Master's or Doctoral degree in a relevant discipline (preferred)

Core Competencies

Demonstrates extensive experience in biospecimen management and clinical drug development, with a strong focus on operational effectiveness, regulatory compliance, and team leadership across diverse, global teams. Proven ability to drive process improvements and manage vendor relationships while ensuring high-quality biospecimen collection and tracking.

Highest-signal resume keywords

• Biospecimen Management
• Clinical Drug Development
• GCP/ICH Guidelines
• Project Management
• Vendor Relationship Management

Hard Skills

• Biospecimen Management Systems
• Clinical Development Processes
• Chain-of-Custody Tracking Technologies
• Financial Management
• Resource Planning

Soft Skills

• Outstanding Communication Skills
• Negotiation Skills
• Influencing Skills
• Team Dynamics
• Detail-Oriented

Certifications & Qualifications

• Bachelor's Degree in Relevant Scientific Discipline
• Master's or Doctoral Degree in Relevant Discipline (Preferred)

Industry Keywords

• Clinical Research
• Operational Quality
• Regulatory Guidance
• Translational Medicine
• Biospecimen Collection