Manager, Precision Medicine Operations

Regeneron Pharmaceuticals•Tarrytown, GA

1d•$114,800 - $187,400•Hybrid

About The Position

The Manager, Precision Medicine Clinical Laboratory Study Management (CLSM Manager) will lead and develop a team of Clinical Laboratory Study managers (CLSM) for various therapeutic areas including Immuno-Oncology. In this role, you will be a key driver of precision medicine operational execution partnering with Precision Medicine Strategy Lead (PMSL), clinical study teams, data management (DM), Samples, Kits, Data, Logistics (SKDL), Clinical Laboratory Study Manager (CLSM), and Clinical Laboratory Project Management (CLPM) groups to deliver high-quality samples and data. Through strong cross functional collaboration and operational excellence, you will help ensure biomarker and non-biomarker strategies are executed seamlessly, enabling the translation of innovative science to medicines for patients.

Requirements

A Bachelor's degree with a minimum of 8 years of pharmaceutical experience in matrix interaction preferably in a pharmaceutical or biotech industry, or in academic or governmental cross-disciplinary teams.
Minimum of 5 years' experience with Clinical Trials, focus on clinical sample collection
Extensive experience in Clinical laboratory operations, biospecimen logistics, and/or clinical study experience requested.
Strong understanding of technical, clinical, and strategic aspects of laboratory operations delivery required.

Responsibilities

Works with project manager and set-up manager of central/specialty lab and clinical study team to build lab database to address clinical trial sample collection needs, kits, testing and logistics
Monitor’s acquisition of clinical trial samples (including human tissue, bone marrow aspirate, whole blood, plasma, serum, etc.) and ensure compliance with ICF permissions
Supports individual clinical study teams as required for all technical and operational sample-related matters for assigned projects by liaising with internal stakeholders working on ICF and other trial documents impacting samples and testing
Work closely with central lab and/or specialty lab project managers, clinical trial management team, and CRO to ensure samples are collected per protocol and assist with resolving any sample related issues or queries.
Oversees Study start up, closeout and overall life-cycle activities for assigned studies at central lab/specialty labs to support all samples and testing
Provides input on sample-related section in clinical trial-related (e.g. protocols and ICF) and other supporting documents
Works closely with data management lead and SKDL to determine how sample and testing data will be captured, blinded and transferred for clinical trials.
Enables transfer of sample/testing data from vendors through development and review of appropriate data transfer specification and related documents in collaboration with SKDL.