About this role
Responsibilities
Strategic Operations & Trial Lifecycle Support
Sample strategy execution: Partner with Clinical Operations, Clinical Science, Clinical Development, Translational Medicine, Clinical Pharmacology, and Non-Clinical to translate scientific and development objectives into executable study-level sample management plans.
Protocol and informed consent input: Collaborate with Clinical Science, Clinical Development, Translational Medicine, Clinical Pharmacology, Non-Clinical, and Clinical Operations to review clinical protocols, Investigator’s Brochures, informed consent forms, and related study documents and confirm that biological sample collection, processing, testing, storage, future-use, and destruction requirements are scientifically aligned, operationally feasible, and clearly defined.
Laboratory manual oversight: Lead the authoring, cross-functional review, approval, and maintenance of study-specific laboratory manuals, sample collection instructions, and associated site materials.
Collection kit readiness: Oversee design, production, distribution, inventory, and replenishment of sample collection kits for global investigative sites.
Study execution: Represent Clinical Sample Operations on cross-functional study teams comprising Clinical Operations, Clinical Science, Clinical Development, Translational Medicine, Clinical Pharmacology, Non-Clinical, and other relevant functions; proactively identify risks and implement mitigation and escalation plans to protect sample quality and study timelines.
Sample Logistics, Tracking & Data Integrity
Chain of custody: Maintain oversight of the complete end-to-end lifecycle and chain of custody of clinical samples from site collection through transport, receipt, processing, testing, transfer, long-term biorepository storage, return, or final destruction.
Global logistics: Coordinate shipment strategies and resolve time-sensitive issues related to couriers, customs, import/export requirements, temperature excursions, sample integrity, and site compliance.
System implementation: Lead the development, implementation, validation support, and optimization of sample tracking systems and laboratory information management systems across clinical studies.
Data reconciliation: Oversee routine cleaning and reconciliation of sample metadata across electronic data capture systems, interactive response technologies, laboratory data transfers, and sample tracking platforms to support interim analyses and database lock timelines.
Metrics and reporting: Develop portfolio- and study-level dashboards that provide visibility into sample collection, shipment status, assay readiness, discrepancies, and operational risk.
Education & Experience
- Bachelor’s degree in life sciences, biology, bioengineering, healthcare, or a related scientific discipline is required; an advanced degree is preferred.
- Senior Manager level: Typically 6–8+ years of progressive experience in clinical operations, clinical sample management, biomarker operations, laboratory operations, or a related function within biotechnology, pharmaceutical, or contract research organizations.
- Associate Director level: Typically 8–10+ years of relevant experience, including at least 2–3 years of direct people management or leadership of matrixed project teams.
- Direct experience supporting oncology clinical trials involving complex, multi-assay biomarker strategies is strongly preferred
- Demonstrated knowledge of the clinical sample lifecycle, laboratory operations, chain of custody, sample logistics, assay workflows, data transfers, and sample data reconciliation, with the ability to integrate requirements across Clinical Operations, Clinical Science, Clinical Development, Translational Medicine, Clinical Pharmacology, and Non-Clinical.
- Proven experience selecting, contracting with, budgeting for, and overseeing central laboratories, specialty laboratories, biorepositories, and logistics vendors.
- Working knowledge of ICH-GCP, GxP principles, global regulatory expectations, informed consent requirements, data privacy, and biospecimen-related ethical considerations.
- Proficiency with eTMF platforms, clinical trial management systems, electronic data capture platforms such as Medidata Rave, and sample tracking or LIMS solutions.
Core Competencies
- Exceptional cross-functional stakeholder-management skills, with the ability to build alignment across Clinical Operations, Clinical Science, Clinical Development, Translational Medicine, Clinical Pharmacology, Non-Clinical, and external partners.
- Strong strategic planning, project management, prioritization, and vendor-governance capabilities.
- Acute attention to detail and a consistent commitment to data integrity, quality, and compliance.
- Excellent written and verbal communication skills, including the ability to translate complex scientific and operational requirements into clear plans and decisions.
- Proactive, solutions-oriented, “roll-up-your-sleeves” mindset with the judgment and composure to resolve logistics issues in real time.
- Ability to thrive in a fast-paced, highly collaborative, and evolving biotechnology environment while managing multiple studies and priorities.