14 jobs found in armonk

The Regeneron GVP Quality Management Lead (QML) is a key position that we believe will guide and lead all aspects of quality and compliance within global pharmacovigilance (PV) system. We expect the Sr. Manager to build strategic partnerships and direct risk-based quality management activities with key partners impacting the global Regeneron PV system. Furthermore, the GVP QML Sr. Manager will be responsible for supporting inspection readiness at all times. The GVP QML will partner with other members of the Global Development Quality Governance and Oversight (GDQGO) department to identify trends through metrics in order to diagnose and remediate systemic quality issues. In this role, a typical day might include the following: Responsible for leading GVP-compliant activities from a quality perspective in conjunction with business and Associate Director / Director, GVP QML Engage with, support and liaise with multiple cross-functional collaborators whose work impacts the...

We are seeking a Director to join our Precision Medicine team. The Director, Precision Medicine will lead Companion Diagnostics (CDx) strategy working closely with Senior Director, Precision Medicine CDx and key cross-functional collaborators to deliver innovative diagnostics solutions in support of Regeneron programs. The primary role will be to guide strategy for patient selection/stratification passionate about immunohistochemistry (IHC) and lead implementation and execution of CDx assays (from study conduct, sample management testing to launch) in collaboration with partners/IVD Sponsors and central testing laboratories to support early and late-stage programs within our oncology pipeline. As a Director, a typical day may include the following: Define innovative diagnostic strategies and be able to propose projects from idea to implementation taking into consideration all of the relevant inputs Develop strong relationships partnerships with IVD partners and testing...

The role of Senior Manager, Diagnostics Program Management & Operational Delivery, is expected to manage and deliver a portfolio of diagnostic projects (CDx, IVD, etc.) within Regeneron’s drug development pipeline in close partnership with Diagnostic Strategy Leads and IVD Regulatory. This role includes portfolio management, 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. As a Senior Manager, a typical day may include the following:...

The Senior Clinical Study Lead (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out.  The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP.  This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly.  Contributes and drives ongoing process improvement initiatives.  This role has a 3-day onsite minimum requirement at either Basking Ridge, NJ, Armonk, NY, Uxbridge, London, or Dublin, Ireland. A typical day in this role looks like: Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and...

This role is a hybrid position which requires a minimum 3 days on-site in Basking Ridge, NJ or Armonk, NY. Remote work is not an option for this role. The Program Operations Leader (POL) will lead and implement the operational strategy for delivery of one or more complex programs in Clinical Trial Management (CTM). This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. The POL is responsible for line management of clinical trial management staff (including AD POL), and...

This role is a hybrid role on-site 3 days per week and 2 days from home. A fully remote role is not possible. The Director Program Operations Leader (POL) is responsible for leadership and overall strategic management of one or more complex programs in Clinical Trial Management (CTM). This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The Dir POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. The Dir POL is responsible for line management of clinical trial management staff, including responsibility for staff recruitment,...

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 laboratory deliverables across the portfolio, ensuring that study start timelines are met , provide risk management. Collaborates with stakeholders for all aspects of 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.   As an Associate Director, a typical day may include the following:...

We are seeking a highly motivated Senior Manager, Business Operations Cost Management, who will be responsible for cost management activities regarding running clinical trials.   The Senior Manager, Business Operations Cost Management, will work at the portfolio, program and functional levels to provide prospective and retrospective measurements of cost, productivity, efficiency, and quality to facilitate informed decision making for Regeneron’s clinical development portfolio.  The Senior Manager, Cost Management will act as a business partner providing critical business operations support to GD, Development Operations & Portfolio Management (DO&PM) functional leadership, Procurement and Finance. This role has a 3-day onsite minimum requirement in one of our office locations. This role is NOT eligible fully remote. Relocation assistance will be provided to those who qualify. A typical day in this role as a Sr Manager looks like: Understand how CROs apply...

The Senior Director, Precision Medicine Strategy Lead role is critical for the successful execution of Regeneron biomarker strategies. Will be accountable for leading a team responsible for overseeing the development and execution of biomarker strategies for the burgeoning Oncology Portfolio in Clinical Development at Regeneron. This is a strategic role responsible for independently designing, developing, communicating at senior levels and overseeing the implementation of clinical biomarker strategies across key programs in early and late stage drug development. Further, this role is responsible for providing subject matter expertise to drive successful relationships with both internal groups at Regeneron as well as external KOLs. Oncology programs comprise nearly half of the overall growing Regeneron development portfolio, including novel modalities, targets and combination therapies. This role has a 3-day onsite minimum requirement in Armonk, NY or Basking Ridge, NJ. As a...

This is a hybrid position that requires 3 non-consecutive days on-site in Armonk, NY or Basking Ridge, NJ, and 2 days from home. A fully remote role is not possible for this position. The Associate Director, Strategic Facilitation will objectively lead discussions or workshops ensuring business objectives are reached efficiently and effectively. The Associate Director, Strategic Facilitation will help individuals and groups identify their purpose and articulate key actions they must take to ensure they realize their purpose, designing each experience utilizing tools and methodology that suits the required challenge, issue, and outcome. The Associate Director, Strategic Facilitation will project manage workshop outcomes as needed. The Associate Director, Strategic Facilitation will support the Director in the creation and leadership of a facilitation center of excellence and Community of Practice. In a typical day, you will: Design and manage complicated engagements that...

The Project Manager provides support for complex cross-functional strategic projects as directed by Senior Project Managers or Program Managers. The Project Manager will support driving and delivering results per charter goals, managing scope, schedule, quality, resources, risk and value/ benefit.  The Project Manager will also manage medium to small projects independently for the business or internal to the function with oversight by more seasoned Program/Project Managers or leadership. A Typical Day Might Look Like this: Plan, manage, execute and deliver a project through its lifecycle within the approved scope, schedule and budget  Secures acceptance and approval of deliverables and perceived value from the Project Lead and Stakeholders  Estimates and coordinates project resources  Maintains the Project Charter, schedule, issues log, budget and risk management plan Manages the risk register and the escalation of risks and issues. Partners with Change...

The Senior Clinical Study Lead (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out.  The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP.  This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly.  Contributes and drives ongoing process improvement initiatives.  This role has a 3-day onsite minimum requirement at either Basking Ridge, NJ, Armonk, NY, Uxbridge, London, or Dublin, Ireland. A typical day in this role looks like: Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and...

The Manager, Global Development Quality Standards & Continuous Improvement (GDQSCI) will support the GDQSCI team with activities related to the maintenance of the Global Development Quality Management System (QMS), quality event oversight and improving processes for quality standards, governance, and oversight, as assigned. This is a hybrid position with 3 days on-site requirement. In this role, a typical day might include the following: • Supporting the engagement of key stakeholders across Global Development functions to proactively identify process improvements, standardizations and regulatory compliance that impacts the Regeneron Global Development quality system. • Responsible for managing the reporting and provision of quality-related metrics and trends to enable functions to continuous improvement. • Responsible for managing the Quality Event (QE) portfolio and the provision of Subject Matter Expert (SME) expertise and guidance to relevant functional areas...

This is a hybrid position on-site 3 days per week in Armonk, NY or Basking Ridge, NJ and 2 days from home. A fully remote role is not possible for this position. The Senior Director, Transformation Program Management will play a vital role in the planning, execution and delivery of cross-functional and complex non-drug strategic and transformational initiatives for Global Development and other areas of Regeneron as requested. This role will collaborate closely with senior and executive leaders and stakeholders to drive the business transformation across the organization. The Senior Director Transformation Program Management communicates and collaborates with executive stakeholders and customers to ensure alignment and satisfaction. This role consults and negotiates with the Director Business Transformation Lead and Director Transformational Change & Engagement to translate business objectives into programs of work to be executed upon. This role requires a visionary leader...