Executive Director, Global Biospecimen Management

 

Position Summary:

 

Reporting to the VP, Central Lab Service, the Executive Director Global Biospecimen Management will provide leadership and strategic direction to the global sample management teams in providing central laboratory services for clinical sample management. This includes global alignment for sample tracking, chain of custody, accessioning and inventory, storage, and sample processing. This person will lead the global team of sample managers and associates to implement and maintain processes for efficient and compliant clinical sample management, working with internal and external partners and stakeholders to implement and maintain a compliant end to end process for biospecimen management across all PFM Global Laboratories.

 

Essential functions of the job include but are not limited to:

 

• Planning, coordinating, and overseeing all planning activities required to manage the lifecycle of biospecimen samples (collection, processing, analysis, data delivery and cleaning process, and final sample disposition)
• Oversight and understanding of Informed Consent, IRB, and reviewing of lab spec./lab manuals
• Represent Global Biospecimen group in protocol level meetings and teams on an ad hoc basis
• Troubleshoot routine problems and escalate issues appropriately
• Serve as a point of escalation to provide guidance to staff and/or directly resolve issues with partners and stakeholders
• Identify and implement systems and tools consistent with current best practices for the pharma industry (domestic and international)
• Support commercial efforts in go-to-market strategy and business development
• Develop and execute robust plan to broaden clinical sample management (CSM) across the Precision ecosystem
• Oversee all clinical sample (biospecimen) management activities across Phase 1 to Phase 3 multinational trials
• Proactively maintain efficient cross-functional interactions between the CSM team and Clinical Operations, Clinical Pharmacology, Clinical Data Management, and other departments
• Serves as a resource to ensure biospecimen collection strategies, documentation, and reporting are compliant within ICH and GCP Guidance
• Represent and serve as the subject matter expert during audits and inspections;
• Coach and mentor CSM staff;
• Participate in corporate development of methods, techniques and evaluation criteria for projects, programs, and people;
• Develop corporate and/or organizational policies and authorizes their implementation;
• Interact frequently with senior leaders regarding matters of significance to the organization;
• Contribute to the development and implementation of the clinical program strategy and manage systems and programs to meet company goals and objectives;
• Identify program and resource gaps with proposed solutions.

 

 

Qualifications:

Minimum Required:

• Minimum Bachelor’s degree required
• Minimum of 12 years related life science industry experience with at least 10 years of experience managing CROs;

 

Other Required:

• Clinical sample (biospecimen) management experience in global clinical trials is required
• Minimum of eight (8) years of experience leading teams
• History of developing and leading a sample management team
• Understanding of end-to-end biospecimen management lifecycle, i.e., biospecimen collection, processing, storage, shipping and destruction
• Understanding of informed consent and its impact on biospecimen management
• Understanding of managing central and specialty lab’s handling of biospecimens, biospecimen collection kits, protocol deliverables, timelines and test results as related to the 3 phases of a clinical trial, i.e., Protocol Concept & Study Start-up, Enrollment & Maintenance, and Close-Out Phases
• Understanding of GxP principals and how they impact biospecimen operational and vendor management activities, and what appropriate steps and path need to be taken to escalate
• Understanding of study protocol objectives and methodology
• Understanding of financial documents for review, standardization and coaching
• Experience with and understanding of ICH and GCP guidelines
• Demonstrated ability to solve problems with innovative solutions along with strong organizational and leadership skills
• Excellent written and verbal communication skills
• Self-starter and team player with strong interpersonal skills
• Excellent project and time-management ability
• Strong computer skills with a proficiency in Microsoft Project, Word, Excel, and PowerPoint.

 

Preferred:

• PharmD or MS/PhD (or similar advanc