Position - Temp - Companion Diagnostics Project Management & Operational Delivery
Pay Range - $106.76/hr - $138.54/hr
Location - Armonk, NY
Duration - 9 Months

The role of Temp - 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.

A typical day might include the following:

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

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

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

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

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

This role may be for you if have:

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.)

To be considered for this role, you must have a minimum of 7+ years of multi-disciplinary experience in biotech/pharmaceutical industry including diagnostic industry or CAP/CLIA laboratory setting minimum of 3+ years in a direct project/program management role.

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