Regeneron
ManagerPrecisionMedicine
Neural analysis suggests this role is
optimal for Manager candidates.
“Manager Precision Medicine at Regeneron. Skills: Precision Medicine, Operational Execution. Lead and develop a team. Partner with Precision Medicine Strategy Lead”
What You'll Achieve.
Deliver high-quality samples; Deliver high-quality data; Ensure biomarker strategies are executed; Ensure non-biomarker strategies are executed; Achieve key trial level milestones on schedule
Industry & Context.
Identify problems; Determine resolutions
What They're Looking For.
Must Have
Bachelors degree, 8 years pharmaceutical experience, 5 years experience with Clinical Trials, Extensive experience in Clinical laboratory operations, Extensive experience in biospecimen logistics, Extensive experience in clinical study management, Understanding of technical aspects of laboratory operations, Understanding of clinical aspects of laboratory operations, Understanding of strategic aspects of laboratory operations, Clinical study knowledge, Knowledge in science and technology
Nice to Have
Leadership tendencies, Ability to proactively identify problems, Ability to determine resolutions, Ability to set priorities, Ability to direct projects, Ability to work cross-functionally, Manage expectations, High level of emotional intelligence, Effectively work collaboratively with colleagues, Effectively work collaboratively with vendors, Effectively work collaboratively internally at Regeneron
What You'll Do.
Lead and develop a team
Partner with Precision Medicine Strategy Lead
Partner with clinical study teams
Partner with data management
Partner with CLPM groups
Deliver high-quality samples
Deliver high-quality data
Ensure biomarker strategies are executed
Ensure non-biomarker strategies are executed
Work with project manager to build lab database
Work with set-up manager to build lab database
Monitor acquisition of clinical trial samples
Ensure compliance with ICF permissions
Support clinical study teams
Liaise with internal stakeholders
Work closely with central lab project managers
Work closely with specialty lab project managers
Work closely with clinical trial management team
Work closely with CRO
Ensure samples are collected per protocol
Assist with resolving sample related issues
Assist with resolving sample related queries
Oversee Study start up activities
Oversee Study closeout activities
Oversee overall life-cycle activities
Provide input on sample-related section
Determine how sample data will be captured
Determine how testing data will be captured
Determine how sample data will be blinded
Determine how testing data will be blinded
Determine how sample data will be transferred
Determine how testing data will be transferred
Enable transfer of sample data from vendors
Enable transfer of testing data from vendors
Develop data transfer specification
Review data transfer specification
Provide guidance to clinical teams
Provide guidance to clinical sites
Ensure sample collection is in compliance
Ensure sample usage is in compliance
Ensure sample collection is in compliance with ICF
Ensure sample usage is in compliance with ICF
Manage performance of CLSMs
Ensure key trial level milestones are achieved
How You'll Work.
Team & Collaboration
Cross-functional collaboration; Work with clinical study teams; Work with data management; Work with SKDL; Work with CLSM; Work with CLPM groups; Work with central lab; Work with specialty lab; Work with CRO; Work with scientists; Work with clinical team; Work with colleagues; Work with vendors; Work internally at Regeneron
Communication Scope
Manage expectations
Process & Methodology
Clinical trial management, Study start up, Study closeout, Life-cycle management
Full Job Description
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 Non-Immuno-Oncology (non-IO). 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. ## **As a CLSM Manager, a typical day may include the following:** * 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 d
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