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Pay Range: $105.24 - $134.15/hr
Onsite Role in Armonk, NY or Warren, NJ
Regeneron is seeking a Manager, Companion Diagnostics Project Management & Operational Delivery
In this role, a typical day might include:
The role of Manager, Diagnostics Project Management & Operational Delivery, is expected to manage and deliver several diagnostic projects (CDx, IVD, etc.) within Regeneron’s drug development pipeline in close partnership with Diagnostic Strategy Leads and IVD Regulatory. This role includes program/project management and operational execution of complex diagnostic strategies to support clinical programs across a variety of therapeutic indications. The successful candidate will work cross-functionally within Diagnostic team, Precision Medicine and other functions internally to anticipate and meet the needs of these programs as well as ensure seamless delivery to milestones. Additionally, this role will serve as a key point of contact with external diagnostic partners, laboratories and vendors required to support development and delivery of the diagnostic strategies.
This role might be for you if you can/have:
Project Management and Leadership
Proactively manage assigned portfolio of diagnostic projects supporting Regeneron’s drug development programs with Diagnostic Portfolio Manager
Build relationships with key stakeholders in clinical development units and other functions to support assigned programs and studies
Facilitate diagnostic assessments to ensure the Dx team is supporting all relevant clinical programs
Drive collection of information to support program deliverables
Track timelines/deliverables and communicate effectively to cross-functional stakeholders
Working with the diagnostic team and key internal functions, establish and execute partnership and operational strategies to enable delivery of diagnostic projects
Develop, build and implement processes and tools to support and the Diagnostics function to ensure quality, efficient and timely delivery
Effectively partner with external diagnostic manufacturers, laboratories and vendors to support delivery of diagnostic tools and strategies. Provide oversight and leadership of external relationships as needed.
Represent Diagnostics team as an expert and leader to drive knowledge of diagnostic delivery, learning, regulatory impacts and operational considerations
Diagnostics Project Execution:
Partner with the CDx/IVD Strategy Lead and other key functions to identify and track deliverables to ensure successful execution of the overall diagnostic strategy
Drive the execution of the Dx/CDx strategy in parallel to the corresponding Regeneron clinical drug development programs and studies with close collaboration to CDx Strategy Leads, clinical laboratory managers, IVD regulatory and others as required
Communicate effectively with stakeholders to resolve quality issues and ensure continuous improvement internally and with our Dx partners.
Coordinate CDx activities in partnership with the CDx Strategy Lead and coordinate broader clinical study team / functional areas
Oversee and lead activities of external partners and vendors (diagnostic partners, central laboratories and testing laboratories).
Develop and maintain project plans to closely track CDx development and CDx regulatory activities against clinical drug development and study timelines
Track and lead project scope, costs, budget, contracts, timelines, risks and dependencies
Review clinical protocols, informed consent documents and other clinical trial deliverables and work with other key reviewers to ensure accuracy of diagnostic representation
Demonstrate high acumen regarding assay development and laboratory build, quality and execution for use of IVDs and CDx in clinical trials
Coordinate laboratory specifications, builds and start up to ensure compliant assay is ready for clinical trial patient testing
Oversee diagnostic data delivery including clinical database lock plans and oversight of samples and data required to support diagnostic strategies and submissions
Oversee critical samples, testing processes and quality; work with teams to resolve any related issues and escalate as needed
Clinical Drug Development Program and Study Team Involvement:
Serve as an active member of clinical study teams to ensure Dx/CDx planning is in line with clinical study plans and to ensure study teams are informed of Dx/CDx activities, status, budget and timelines
Support Dx/CDx Strategy Lead and Dx/CDx management with information relevant to driving program strategy in participation with Strategic Program Teams
Stakeholder Management & External Collaborations
Manage and integrate with team members from functional groups across Regeneron using data driven approaches
Partner with laboratory operations team to align on biomarker testing and sample oversight activities
Work closely with external diagnostic partners, central laboratories and specialty testing labs
To be considered for this opportunity, you must have the following:
Minimum of 5-7 years of multi-disciplinary experience in biotech/pharmaceutical industry including diagnostic industry or CAP/CLIA laboratory setting
Demonstrated experience in oncology clinical trials with a companion diagnostic and biopsy / tumor tissue sample management and tracking
Certificate in Project Management from an accredited university
Minimum of 3+ years in a direct project/program management role
Experience with project management tools to provide timelines and identify milestones
Strong collaboration and communication skills
Experience working with cross-functional clinical study teams
Understanding of GxP, CAP/CLIA, IVDR and applicable ISO regulations
Strong understanding of clinical laboratory practices, validation procedures and regulatory requirements
Strong communication and presentation skills
Proficient in business technology tools and understanding data (e.g. Microsoft Teams, Excel, PowerPoint, etc.)
This is a contract position at Regeneron with Magnit Global being the Employer.
To do our best work we need different viewpoints. Therefore, we celebrate diversity and embrace inclusion. As an equal opportunity employer, we are dedicated to building a team that represents a variety of backgrounds, perspectives, and skills. We strive to ensure that we maintain a positive and enriching work environment for all.
W2 only, no third party solicitation
