Senior Manager or Associate Director, Translational Medicine Operations

How you’ll make an impact:
- Lead Translational Medicine (TM) operations for clinical studies, overseeing end-to-end biospecimen management from study start-up through closeout.
- Develop and execute biospecimen operational strategies (collection, processing, handling, shipment, tracking, reconciliation, archival).
- Manage central laboratory and vendor operations (study setup, contract management, laboratory documentation, assay support, kit management, performance oversight).
- Partner cross-functionally with Translational Medicine, Clinical Operations, Biomarker Scientists, CROs, CRUs, and external vendors.
- Oversee site operational readiness (study start-up, investigator training, collection procedures, issue resolution).
- Monitor biospecimen quality and data integrity (sample deviations, root cause analysis, CAPA).
- Lead operational execution for complex, multi-site studies (risk identification, escalations, mitigation).
- Ensure compliance with study protocols, regulatory requirements, and company standards; drive process improvements.

Skills and experience you’ll bring:
- 7–10+ years in Translational Medicine Operations, Clinical Sample Management, Biomarker Operations, or related drug development (biotech/pharma/CRO).
- Bachelor’s in Life Sciences/Biology/Biomedical Sciences/Clinical Laboratory Science or related.
- Advanced degree (MS/MPH/PhD) preferred.
- Phase I–III end-to-end biospecimen operations experience.
- Experience managing central/specialty labs and vendors; laboratory manual review; kit management; issue resolution.
- Experience creating biospecimen operational documents (laboratory manuals, sample management plans, collection/processing guidelines).
- Knowledge of clinical trial operations; collaboration with Clinical Ops, CROs, sites, CRUs.
- Vendor contracts/SOW/budgets; partner with Legal, Procurement/Sourcing, Finance.
- Experience managing sample deviations and ensuring sample/data integrity.
- Knowledge of GCP/ICH, chain of custody, handling best practices, regulatory requirements.
- Experience with sample tracking systems and Smartsheet (or similar).
- Strong project management; risk/timeline management; cross-functional alignment.
- Preferred: Phase I/II immunology experience.
- Preferred: pharmacodynamic assays, flow cytometry, genomics/transcriptomics, IHC or other biomarker platforms.
- Preferred: assay validation and lab technology transfers.