Manager, Precision Medicine Operations

About the role

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.

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
• Maintains oversight of clinical trial sample acquisition (including human tissue, bone marrow aspirate, whole blood, plasma, serum, etc.) and ensures compliance with informed consent forms (ICFs)
• Liaises with internal stakeholders working on ICF and other trial documents impacting samples and testing
• Supports individual clinical study teams as required for all technical and operational sample-related matters for assigned projects
• 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
• Collaborates with data management lead and SKDL to determine how sample and testing data will be captured, blinded and transferred for clinical trials
• Ensures the 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, 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

Qualifications

• Strong communication and interpersonal skills
• Ability to manage multiple projects simultaneously
• Experience with regulatory requirements and compliance
• Knowledge of laboratory equipment and techniques

Skills

• Excellent organizational and problem-solving skills
• Strong leadership and team management abilities
• Proficiency in Microsoft Office Suite

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

$114,800.00 - $187,400.00 annually

Schedule

Hybrid: 4 days per week on site