Senior Manager, Clinical Lab Study Manager

Regeneron Pharmaceuticals • Warren, MI

11h

About The Position

The Senior Manager, Precision Medicine Clinical Laboratory Study Management (CLSM Senior Manager) will lead and develop a team of Clinical Laboratory Study managers (CLSM) for various therapeutic areas including Immuno-Oncology (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 Senior Manager, a typical day may include the following: Clinical Trial Study Team Support Participates in cross-functional study teams and sub-teams across clinical and research departments 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 Support cross functional internal and external collaborators to manage and support the generation of high-quality laboratory data. 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. Serves as CLSM subject matter expert contact for assigned therapeutic areas including IO. Allocates and prioritizes FSP CLSM and Sr. PMA resources within the assigned therapeutic program and studies. Manages FSP CLSM team for technical and operational support on their assigned therapeutic program and studies. Operational Support of Sample Analysis (Including Exploratory Analysis) Oversees Study start up, closeout and overall life-cycle activities for assigned studies at central lab/specialty labs to support all samples and testing Forecasts sample related operational costs and reviews invoices to ensure we are aligned with budget plans Provides input on sample-related section in clinical trial-related (e.g. protocols and ICF) and other supporting documents Prepares RFPs, reviews and assess bids and SOWs for items related to samples and testing Provides guidance and trainings to vendors, collaborators and clinical sites on sample collection, processing, shipping, and storage Data Acquisition and Management 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. Human Sample Management Flow and Compliance Provides guidance to clinical teams and clinical sites regarding collection and storage of samples acquired during clinical trials or other human sample acquisition projects Works with scientists and clinical team to ensure sample collection and usage is in compliance with study protocol and applicable ICF Collaborates with internal Human Sample Management team to ensure all samples transferred to internal research groups are documented, tracked, used, and destroyed This role may be for you if: You possess strong leadership tendencies, ability to proactively identify problems, determine resolutions, set priorities, and direct projects and work cross-functionally to manage expectations with excellent communication and collaborative skills and work well in a team-based environment. The CLSM Senior Manager will be responsible for day-to-day oversight of multiple CLSMs, including responsibility for coaching, mentoring and performance management ensuring applicable key trial level milestones are achieved on schedule. You demonstrate strong leadership skills and possess high level of emotional intelligence and effectively work collaboratively with colleagues, vendors and internally at Regeneron to ensure program success.

Requirements

• Bachelors
• Minimum of 8 years 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.
• clinical study knowledge, demonstrated by knowledge in science and technology.
• Demonstrated experience in stake holder management, leading internal and external meetings and solutioning skills.

Responsibilities

• Participates in cross-functional study teams and sub-teams across clinical and research departments
• 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
• Support cross functional internal and external collaborators to manage and support the generation of high-quality laboratory data.
• 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.
• Serves as CLSM subject matter expert contact for assigned therapeutic areas including IO.
• Allocates and prioritizes FSP CLSM and Sr. PMA resources within the assigned therapeutic program and studies.
• Manages FSP CLSM team for technical and operational support on their assigned therapeutic program and studies.
• Oversees Study start up, closeout and overall life-cycle activities for assigned studies at central lab/specialty labs to support all samples and testing
• Forecasts sample related operational costs and reviews invoices to ensure we are aligned with budget plans
• Provides input on sample-related section in clinical trial-related (e.g. protocols and ICF) and other supporting documents
• Prepares RFPs, reviews and assess bids and SOWs for items related to samples and testing
• Provides guidance and trainings to vendors, collaborators and clinical sites on sample collection, processing, shipping, and storage
• 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.
• Provides guidance to clinical teams and clinical sites regarding collection and storage of samples acquired during clinical trials or other human sample acquisition projects
• Works with scientists and clinical team to ensure sample collection and usage is in compliance with study protocol and applicable ICF
• Collaborates with internal Human Sample Management team to ensure all samples transferred to internal research groups are documented, tracked, used, and destroyed
• responsible for day-to-day oversight of multiple CLSMs, including responsibility for coaching, mentoring and performance management ensuring applicable key trial level milestones are achieved on schedule.

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior