Associate Director

Regeneron's Precision Medicine organization is seeking an Associate Director to join our team!

In this role, a typical day may include:

The Associate Director, Precision Medicine Clinical Laboratory Operations will be responsible for Clinical Laboratory Project & Program management for various therapeutic areas working closely with Director, Precision Medicine Clinical Laboratory Operations and key cross-functional collaborators. The primary role will be to provide strategic oversight of biomarker operational delivery and clinical laboratory deliverables across the portfolio; ensuring that study start timelines are met, provide risk management and collaborate with stakeholders for all aspects of biomarker and clinical laboratory deliverables (from study conduct, sample management testing to launch).  This will be done in collaboration with Precision Medicine Strategy Leads, Clinical Trial Management, Clinical Laboratory Operations Management, Global Development colleagues and central and specialty testing laboratories to support early and late-stage programs within our pipeline.

This role might be for you if you can/have:

Therapeutic Area Lead Oversight, Clinical Laboratory Management

• Perform strategic and clinical laboratory portfolio management for Regeneron clinical trials based off the requirements in a clinical trial protocol and schedule of events/assessments.

• Lead program teams through operational lab delivery; Review clinical laboratory operations timelines and risks and be able to manage and communicate risks and ensure study starts and data delivery are aligned with expectations.

• Be a subject matter expert on central and specialty laboratory processes, lab project management, vendor management, ICH/GCP and leverage this knowledge to be a trusted stakeholder and ensure clinical laboratory deliverables.

Therapeutic Area Lead Oversight, Biomarker Project Management, Precision Medicine

• Close Collaboration with stakeholders including Precision Medicine Strategy Leads (PMSL) and Clinical Laboratory Strategy Management team, to plan, monitor, and update biomarker strategy delivery schedules for clinical development programs and studies, identifying and tracking risks and decisions, creating mitigation plans. Manage the delivery of complex biomarker deliverables with internal and external colleagues.

• Required to inform and shape clinical laboratory operations goals, including progress, schedules of testing/data generation across the portfolio with clear objectives and deadlines.

Stakeholder Management (internal/external), Enhanced Communication, Risk Identification/Solutioning

• Develop strong relationships and trust with internal and cross functional partners, senior leadership, including Precision Medicine Clinical Lab Study Management, Precision Medicine Strategy Leads and others within Global Development to manage and implement program level clinical laboratory management.

• Oversee operational aspects of clinical trial laboratory implementation and communicate effectively both externally and internally.  Where needed identify solutions for barriers to success in the clinical laboratory space.

• Be viewed as an operational subject matter expert to effectively communicate with clinical study teams on laboratory program direction.  Demonstrate authority for the studies related to the program, with frequent executive summaries. Established as a leader for the program and can dive into the details when required, with attention to detail.

• Bridge laboratory clinical trial operations work through research teams and tech centers at Regeneron, managing timelines for the lab delivery in clinical trials and other human sample projects to ensure seamless execution and adherence to project deadlines.

• Provide subject matter expertise on human sample management projects, including acquiring samples from outside sources and executing new project ideas to support innovative research initiatives.   

• Create and communicate enhancements to Clinical Laboratory Project Management and connections through the matrix environment, design and develop processes to address identified gaps.

Decision Making and Consistency of Operational Delivery

• Lead and facilitate decision-making forums for clinical lab strategy within the portfolio, while identifying and adjusting new processes as required with forward-thinking, big-picture skill sets.

• Demonstrate relevant knowledge and understanding of clinical laboratory trial requirements on the program and execute strategic operational decisions. Ensure the laboratory portion of the studies are harmonized for assigned program from onset to final delivery.

• You possess strong leadership tendencies, ability to proactively identify problems, determine resolutions, set priorities, and direct projects and work cross-functionally to manage expectations with excellent communication and collaborative skills and work well in a team-based environment. 

• This role will be responsible for line management of staff, including responsibility for staff recruitment, development, coaching, mentoring and performance management.

• You demonstrate strong leadership skills and possess high level of emotional intelligence and effectively work collaboratively with colleagues, vendors and internally at Regeneron to ensure program success.

To be considered for this opportunity, you must have the following:

• Bachelors Degree with a minimum of 8 years 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.

• We need a strong understanding of technical, clinical, and strategic aspects of laboratory operations delivery required.

• We are seeking clinical study knowledge, demonstrated by knowledge in science and technology.

• Demonstrated experience in stakeholder management, leading internal and external meetings and solutioning skills.

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