Manager, Clinical Samples

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.

Position Summary: The Samples Manager, Clinical Trial Operations is responsible for participating in central lab strategic planning, hands-on samples operational oversight, and providing input into governance of all clinical trial lab sample activities across assigned global studies. This includes the Sponsor oversight of end-to-end lifecycle process of biological specimens (eg, PD, biomarker, genetic, and safety labs) from site collection, processing, and shipment to analysis and storage. The role serves as the primary point of contact for internal teams, CROs, central laboratories, specialty labs, and other vendors to ensure sample management activities are compliant with GCP, protocol requirements, and global regulations.

The Samples Manager provides input on designing sample handling strategies, develops and maintains sample management SOPs, oversees vendor performance, and proactively mitigates risks. The individual also drives cross-functional alignment to ensure sample-related deliverables meet overall clinical program timelines and quality expectations.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Develop and oversee global clinical sample management strategies for assigned Phase 1–3 trials.
• Lead operational planning for all sample-related activities, including collection, processing, shipping, storage, chain-of-custody, and destruction.
• Collaborate with Clinical Operations, Clinical Pharmacology/Bioanalysis, Data Management, and Regulatory Affairs to ensure sample plans align with protocol requirements and scientific objectives.
• Collaborate with Outsourcing and Vendor Governance (OVG) for  vendor selection and contracting.
• Provide oversight of central labs and assigned specialty labs, couriers, and biorepositories.
• Ensure laboratory manuals and sample handling instructions are complete, clear, and version-controlled.
• Collaborate with central lab to oversee and monitor sample inventory and tracking systems, ensuring accuracy and regulatory compliance.
• Establish and maintain internal metrics and KPIs for sample management performance; present regular updates to study teams.
• Support sample-related sections of protocols, ICFs, and monitoring plans.
• Drive resolution of sample-related issues, deviations, and CAPAs in collaboration with QA and vendors.
• Collaborate with Data Management to resolve queries during reconciliation processes.
• Maintain awareness of evolving global regulations and guidance for biological specimen handling, import/export, and privacy requirements.
• Provide training and subject matter expertise to internal teams, CROs, and site staff.
• Contribute to inspection readiness and participate in audits or regulatory inspections as the SME for sample management.
• Travel as required to support site initiation, vendor audits, and troubleshooting.
• Other duties as assigned

Education and Experience:

• Bachelor’s degree in biological sciences or related discipline; advanced degree preferred.
• 8+ years of relevant clinical trial sample management experience.
• Demonstrated expertise in GCP, ICH guidelines, and global regulations related to biological specimens.
• Proven success in vendor management and cross-functional collaboration.
• Strong project management, problem-solving, and negotiation skills.
• Experience with LIMS, sample tracking software, and EDC/CTMS systems preferred.
• Exceptional organizational and communication skills, with the ability to influence and collaborate at all levels.

Technical Knowledge Required:  

Equipment:   PC, scanners, voice mail and e-mail systems, and common office machines, or ability to be trained.   

Software Knowledge:  Windows, MS Office (Outlook, Word, Excel).   

Physical Demands and Work Environment:

Physical Activities: On