Manager Precision Medicine

Regeneron Pharmaceuticals • Tarrytown, GA

5d • Onsite

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 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.

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.
• Seeking clinical study knowledge, demonstrated by knowledge in science and technology.
• 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.
• 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.

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.
• 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
• 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: Manager