Manager, Precision Medicine Operations

Work Location: Armonk, NY or Warren, NJ
Hybrid: 4 days per week on site

About the Role

Lead and develop a team of Clinical Laboratory Study Managers (CLSM) for various therapeutic areas including Immuno-Oncology. Drive precision medicine operational execution by partnering with the 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. Ensure biomarker and non-biomarker strategies are executed seamlessly to enable the translation of innovative science into medicines for patients.

Responsibilities

• Work with project managers and set-up managers of central/specialty labs and clinical study teams to build lab databases addressing clinical trial sample collection needs, kits, testing, and logistics.
• Monitor acquisition of clinical trial samples (including human tissue, bone marrow aspirate, whole blood, plasma, serum, etc.) and ensure compliance with ICF permissions.
• Support individual clinical study teams 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 teams, and CROs to ensure samples are collected per protocol and assist with resolving any sample-related issues or queries.
• Oversee study start-up, closeout, and overall life-cycle activities for assigned studies at central/specialty labs to support all samples and testing.
• Provide input on sample-related sections in clinical trial-related documents (e.g., protocols and ICF) and other supporting documents.
• Collaborate with data management leads and SKDL to determine how sample and testing data will be captured, blinded, and transferred for clinical trials.
• Enable transfer of sample/testing data from vendors through development and review of appropriate data transfer specifications and related documents in collaboration with SKDL.

Requirements

• 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, with a focus on clinical sample collection.
• Extensive experience in clinical laboratory operations, biospecimen logistics, and/or clinical study experience.
• Strong understanding of technical, clinical, and strategic aspects of laboratory operations delivery.

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

• Annual bonuses or other incentive plans
• Equity awards
• Pension or retirement benefits, 401(k) company match
• Health and wellness programs, fitness centers
• Insurance benefits (e.g., medical, dental, vision, life, and disability)
• Paid time off
• Family support benefits

Pay

Salary Range (annually): $114,800.00 - $187,400.00

Schedule

Hybrid: 4 days per week on site