Associate Director, Precision Medicine - Diagnostics Project Management & Delivery

Regeneron Pharmaceuticals has an exciting new opportunity as an Associate Director, Diagnostics Project Management & Delivery

In this role, a typical day might include :

The role of Associate Director, Diagnostics Project Management & Delivery, is expected to manage and deliver the execution of diagnostic projects (CDx, IVD, etc.) within Regeneron’s drug development pipeline in partnership with Diagnostic Strategy Leads and IVD Regulatory Affairs. This is a leadership role within Regeneron’s clinical diagnostics team to provide portfolio management, program / project management, strategic input and execution of complex diagnostic strategies to support clinical programs across multiple therapeutic areas. The successful candidate will lead and partner cross-functionally within the Diagnostics team, Precision Medicine Strategy, Laboratory Operations, to directly lead and / or lead resources with and without authority. The role will contribute to building a framework to ensure effective planning and handoff from diagnostic strategy to execution phase with both internal and external resources serving as a key point of contact with internal clinical teams, external diagnostic partners, laboratories and vendors. The candidate must have strong expertise in drug development planning and CDx / IVD development with pharmaceutical companies.

This role might be for you if you can :

Project Management and People Leadership :

Proactively plan, manage and execute assigned portfolio of diagnostic projects supporting Regeneron’s drug development programs

Continuously review Regeneron’s drug development pipeline and portfolio, build relationships with key stakeholders in clinical development units and other functions, and facilitate diagnostic assessments to ensure the Dx team is supporting all relevant clinical programs

Leverage tools and other resources to maintain portfolio and project level information to track timelines / deliverables and communicate effectively to cross-functional stakeholders

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 :

Working with the Diagnostic Strategy Lead, define the diagnostic delivery plan and serve as the main point of contact internally and externally for the duration of the diagnostic project

Identify, communicate and manage risks to the strategy and delivery plan

Develop, align and oversee execution of diagnostic development, operational and commercial plans

Manage (with and without authority) a team of resources contributing to delivery of the diagnostic strategy

Communicate effectively with stakeholders to resolve quality issues and ensure continuous improvement internally and with our Dx partners and labs

Develop and maintain project plans to closely track CDx development and CDx regulatory activities against clinical drug development and study timelines

Review clinical protocols, informed consent documents and other clinical trial deliverables and work with other key reviewers to ensure accuracy of diagnostic language

Demonstrate high acumen regarding drug development, assay development and laboratory build, quality and execution for use of IVDs and CDx in clinical trials

Oversee requirements for laboratory specifications, builds and start up activities to ensure diagnostic assay is ready for clinical trial patient testing

Lead oversight of 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 8+ years of experience in biotech / pharmaceutical industry and / or diagnostic industry with strong knowledge of GCP, CAP / CLIA, US FDA and IVDR laboratory and diagnostic requirements

Bachelor’s degree in sciences required, advanced degree or PhD preferred

Demonstrated experience in clinical trial and diagnostic development planning and project management

Experience with project management tools to provide timelines and identify milestones

Strong organization, collaboration, communication and presentation skills

Excellent at thinking and working on the fly and under pressure, problem solving and providing consultative approaches

Experience working with cross-functional clinical study teams

Understanding of GxP, CAP / CLIA, FDA, PMDA, IVDR and applicable ISO regulations

Strong understanding of laboratory practices, validation procedures and regulatory requirements

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