19 jobs found in Sleepy Hollow, NY

As a Manager, Medical Study Operations you will be responsible for all operational aspects of multiple projects/programs such as the Compassionate Use Programs, Investigator-Initiated (IIS) Studies Program, Collaboration Studies.  This is an on-site position will require you to be on-site 3+ days/week at our Sleepy Hollow, NY location. We cannot offer a fully remote option. If eligible, we can offer relocation benefits.  A typical day may include the following:   Operational responsibility across programs within Compassionate Use, Expanded Access Programs, IIS, Pre-Clinical Collaborations, Sample Analysis Studies, Collaboration studies, Data Transparency Participating in team review meetings, product team alignment meetings, and program budget & status update meetings as needed. Accountable for financial forecasting accuracy of studies within span of responsibility. Maintenance of program budget trackers, ensuring communicated actuals and accruals are captured,...

The Executive Director, Biostatistics (CDU-Biostatistics Head, Internal Medicine) leads the statistical team for the assigned Clinical Development Unit, in partnership with leadership within Biostatistics and Data Management, Clinical Sciences, Regulatory Affairs, Development Operations and Development Program Management, R&pD, and other key functions at Regeneron.  The incumbent is an experienced leader, passionate drug developer, skilled manager and mentor, and an accomplished statistician with a strong ability to communicate technical concepts to non-statisticians.   The Executive Director is responsible for providing critical strategic input to the development programs within the CDU, from pre-IPA through regulatory approval and post-marketing, and builds and empowers teams to ensure the successful execution on our pipeline.  The Executive Director drives the development of appropriate phase-specific statistical strategies are developed and implemented, such as...

We are seeking a Director to join our Clinical Development team. The Director Clinical Sciences leads in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. The Director leads in a matrix environment as part of a cross-functional team and may contribute to drug-candidate development projects through early and/or late phase development. The Director reports to the Internal Medicine Clinical Development Unit Lead of Clinical Scientists and collaborates closely with Medical Director(s)to provide scientific expertise vital to design and deliver on clinical studies and programs. As a Director, a typical day may include the following: May function as lead Clinical Scientist for program, and/or as delegate of Therapeutic area Lead Clinical Scientist; Member of the Clinical Study Team and Global Clinical Sub Team Contributes to program team meetings,...

This position is for a qualified statistician/biostatistician to support Clinical Biostatistics with Global Development.  In this role, a typical day might include: ​ The incumbent will lead efforts of the Biostatistics department with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints and frame statistical approaches to address those questions, design clinical experiments and interventional studies to generate and analyze the resulting data, and work with teams to appropriately interpret the results and make decisions.  The incumbent will represent statistical issues in regulatory agency meetings.  The incumbent will lead the development and delivery of training to non-statistical colleagues, lead the development of new infrastructure and processes, and be active in representing the company in professional associations, conferences, and publications.  As an Associate Director, the incumbent will be responsible for...

The Director of Statistical Innovation, Biostatistics and Data Management will serve as a leading expert in statistical methodologies, driving innovation and providing strategic consultation to Regeneron’s Global Development organization. In this role, a typical day might include: This role offers an exciting opportunity to develop and apply cutting-edge statistical methods for drug development. It is ideal for a seasoned statistician with a passion for innovation and a desire to make a significant impact on drug development and patient outcomes. This role might be for you if can/have: Enhance the impact of statistical innovation on clinical trial design and analysis within and beyond Regeneron by fostering a top-tier innovation team. Conduct research in statistical innovation and identify advanced methodologies to improve Regeneron’s ability to deliver new medicines. This includes implementing innovative study designs and conducting complex data analyses...

The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include support to some clinical study activities. The candidate will also supply, lead and/or supervise IND/CTA and BLA submissions activities. In this role, a typical day might include the following: Provide interpretation of regulatory authorities’ feedback, policies and guidelines. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation of major clinical submissions required for regulatory approval. Work with project teams to resolve complex project issues. Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and...

The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include support to some clinical study activities. The candidate will also supply, lead and/or supervise IND/CTA and BLA submissions activities. In this role, a typical day might include the following: Provide interpretation of regulatory authorities’ feedback, policies and guidelines. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation of major clinical submissions required for regulatory approval. Work with project teams to resolve complex project issues. Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret,...

We are looking for a highly motivated Principal Scientist, Clinical Pharmacology in our Pharmacometrics (PMx) group. The position will report to the Senior Group Director (SGD) within Clinical Pharmacology (CP) in the General Medicine (GM) group. You will represent CP on project teams to provide strategic and scientific expertise to support new and ongoing GM clinical programs. This individual is expected to provide significant contributions to PMx deliverables for multiple programs to support the strategies for each program. In addition, this person will prospectively contribute to longer-term development strategies executed over the course of multiple non-clinical experiments, clinical studies and PMx analyses. You will conduct or otherwise oversees the development of PMx analysis plans. This role must be onsite a minimum of 3-days per week at either our Tarrytown, NY or Basking Ridge, NJ location. A typical day as a Clinical Pharmacologist looks like::...

This position is for a qualified statistician/biostatistician to support Clinical Biostatistics within Global Development. As a Principal Biostatistician, a typical day might include: The incumbent will work with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints and frame statistical approaches to address those questions, design clinical experiments and interventional studies to generate and analyze the resulting data, and work with teams to appropriately interpret the results and make decisions. The incumbent will co-author clinical study protocols, statistical analysis plans, and perform statistical analyses for interim and final reports. The incumbent will also develop and deliver training to non-statistical colleagues, collaborate on development of new infrastructure and processes, and influence the external pharmaceutical industry and regulatory environment through participation in professional associations, conferences,...

This position is for a qualified Statistician/Biostatistician to support Biostatistics Scientific Insights within Global Development.  As a Principal Biostatistician, a typical day might include: The incumbent will work with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints and frame statistical approaches to address those questions, design clinical experiments and interventional studies to generate and analyze the resulting data, and work with teams to appropriately interpret the results and make decisions. The incumbent will co-author clinical study protocols, statistical analysis plans, and perform statistical analyses for interim and final reports. The incumbent will also develop and deliver training to non-statistical colleagues, collaborate on development of new infrastructure and processes, and influence the external pharmaceutical industry and regulatory environment through participation in professional...

We are seeking an Associate Director within the Formulation Development Group of Regeneron Pharmaceutical Inc. at Tarrytown, NY. This role will lead clinical and commercial formulation and drug product development activities for peptides, monoclonal antibodies (mAb), antibody-drug conjugates (ADC), fixed dose combinations, and combination products. Specialized focus on obesity and metabolic disease. A typical day in this role might look like: Leads clinical and commercial formulation and drug product development activities for peptides, monoclonal antibodies (mAb), antibody-drug conjugates (ADC), fixed dose combinations, and combination products. Specialized focus on obesity and metabolic disease. Applies demonstrated knowledge of risk management and application of QbD principles to formulation and drug product development. Integrates analytical and process development. Interacts broadly and collaboratively with other Regeneron functions and stakeholders including...

We are seeking a Senior Scientist joining the Drug Product Compatibility/In-use Stability Team within the Formulation Development Group (FDG) of Regeneron Pharmaceuticals, Inc. (Tarrytown, NY). In this exciting role, you will be leading and supporting compatibility/in-use stability and formulation development activities for various therapeutic modalities such as monoclonal antibodies, bispecific antibodies, proteins, ADCs, AAVs. A Typical Day in the Role Might Look Like: Leads compatibility/in-use stability study from planning to execution to support clinical and commercial drug product dose administration for various therapeutic modalities by collaborating with the analytical and formulation teams within the department. Develops fit-for-purpose analytical methods to support compatibility and stability testing, formulation development and product characterization. Drives research and new technical development to expand team’s capability. Develops dosing...

The Head of Clinical Data Management (CDM) is fully accountable for all clinical data management activities in support of the clinical pipeline. This includes, but is not limited to, execution and ownership of the CDM operating model, oversight of internal staff and external CDM partners, and cross-functional leadership for the delivery of high quality and reliable clinical data to enable internal decision making, regulatory approval, and market acceptance. The incumbent interacts with senior level management, partners with external vendors, collaboration partners and provides cross functional strategic direction and is accountable for building and managing a team across functions to identify risks and opportunities as well as innovative approaches to clinical data management. The Head of Clinical Data Management is critical to the success of our clinical trials and the integrity of data that supports regulatory submissions and decision-making. In this role, a typical...

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:...

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...