79 management jobs found in Tarrytown, NY

The Senior Manager, Data Management provides oversight of lead Data Manager(s) on assigned clinical data management projects in multiple therapeutic areas to assure proper planning and execution for data management deliverables that meet Regeneron standards and within timelines. Ensures training for direct reports that have adequate data management skills and are in compliance with all regulatory requirements. Coordinate with Director or Associate Director of Data Management in the development of SOPs, Working Practice, Data Management Manual, and other data management standards In this role, a typical day might include the following: Serves as primary DM contact for assigned therapeutic areas to interact with clinical counterparts for overall project planning and issue resolution. Projects, allocates and prioritizes DM resources within the assigned therapeutic projects. Supervises direct DM reports for planning and managing all relevant DM activities...

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...

Summary As an Associate Director of Publications Management, you will lead cross-functional publication teams to develop, manage and implement the publication plan of one or more therapeutic areas. You will build and update publication plans, and provide summary reports to partners. Job Duties A typical day may include the following: Leading cross-functional publication teams with company partners to develop, manage and implement the strategic medical publication plans in Hematology. This will involve the timely and efficient development and submission of manuscripts, abstracts, and meeting presentations. Guide and have oversight of publication vendors, contract writers and editors, draft budgets, and travel to conferences as needed. Develop a firm scientific understanding of the Hematology therapeutic area; additionally, should possess an understanding of clinical study design, statistics, and pharmaceutical research and development. Familiarity with...

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 Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management activities and decisions including quality, timelines and resources 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 PDML is a member of the Clinical Data 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. In this role, a typical day might include: Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM). Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or...

The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management activities and decisions including quality, timelines and resources 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 PDML is a member of the Clinical Data 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. In this role, a typical day might include: Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM). Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or...

The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management activities and decisions including quality, timelines and resources 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 PDML is a member of the Clinical Data 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. In this role, a typical day might include: Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM). Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or...

The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management activities and decisions including quality, timelines and resources 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 PDML is a member of the Clinical Data 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. In this role, a typical day might include: Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM). Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or...

The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management activities and decisions including quality, timelines and resources 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 PDML is a member of the Clinical Data 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. In this role, a typical day might include: Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM). Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks,...

The Senior Manager, Data Management provides oversight of lead Data Manager(s) on assigned clinical data management projects in multiple therapeutic areas to assure proper planning and execution for data management deliverables that meet Regeneron standards and within timelines. Ensures training for direct reports that have adequate data management skills and are in compliance with all regulatory requirements. Coordinate with Director or Associate Director of Data Management in the development of SOPs, Working Practice, Data Management Manual, and other data management standards In this role, a typical day might include the following: Serves as primary DM contact for assigned therapeutic areas to interact with clinical counterparts for overall project planning and issue resolution. Projects, allocates and prioritizes DM resources within the assigned therapeutic projects. Supervises direct DM reports for planning and managing all relevant DM activities within...

The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management activities and decisions including quality, timelines and resources 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 PDML is a member of the Clinical Data 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. In this role, a typical day might include: Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM). Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or...

As a Senior Director in Pharmacometrics (PPK/PD, QP, or CP as appropriate), this individual will be responsible for managing PMx support for a number of programs in one or more therapeutic focus areas of the development portfolio. In this capacity the Senior Director is accountable for the successful and timely completion of all assignments encompassing a broad array of deliverables in support of the corporate strategic goals. The Senior Director is expected to apply both logistical and strategic initiatives as well as to incorporate novel and creative scientific approaches. A typical day in this role might look like: Utilizing a mastery level of PK/PD knowledge and strategic leadership skills, effectively develop and implement strategic analyses in support of research and development projects. • Adapts plans and priorities that addresses resource and operational challenges. Accountable for the appropriate application of PMx and corporate policies and procedure. • May...

The Senior Manager Clinical Scientist Hematology leads in the development, evaluation, planning and execution of clinical studies and ensures integrity and interpretation of study data of a clinical development program. The Sr. Manager leads in a matrix environment as part of a cross-functional team and may contribute to candidate development projects through early and/or late phase development. The Sr. Manager reports to Director, Clinical Sciences and collaborates closely with Medical Director(s) (MDs) to provide scientific expertise necessary to design and deliver on clinical studies and programs. As a Senior Manager in Hematology Clinical Sciences, a typical day may include the following: Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; participates in collaborative activities with other departments; Member of the Clinical Study Team and Global Clinical SubTeam Develops/maintains...

Regeneron Pharmaceuticals Inc. is seeking a Director Patent Attorney to develop global IP strategies around key molecules, platforms and other technologies to ensure Regeneron’s long-term competitive advantage. This unique in-house opportunity will be part of a high-performing team of IP practitioners devoted to protecting Regeneron’s innovations derived from Regeneron’s cutting-edge science and numerous collaborations, including over 75 collaboration agreements executed in the past 5 years. The patent attorney will enable key synergistic collaborations and acquisitions by providing IP transactional and due diligence support in close partnership with colleagues in the R&D, clinical, regulatory, legal, business and alliance management departments at Regeneron. This role will also advise on emerging legal issues, including monitoring and reviewing case law and legislative developments, and is expected to contribute to administrative and legal projects intended to develop an IP...

The Senior Medical Director, Clinical Development will play a key role in the NASH/MASH clinical development program within the Regeneron Genetic Medicines portfolio, including responsibility for driving forward one or more NASH/MASH clinical programs. This role leads one or more clinical team working closely with key stakeholders , including pre-clinical research, Regeneron Genetics Center, regulatory affairs, clinical operations, and others. This role leads collaborations with discovery scientists and translational geneticist colleagues to understand current and emerging targets/genetic medicines programs, provides input on potential disease areas/indications, and crafts clinical experiments that corroborate or inform the biology for decision-making purposes and enable clinical development programs. This is an exciting opportunity to develope evolving Genetic Medicines modalities include RNA interference (RNAi), gene editing, viral vector gene delivery, and others. A typical...

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...

As Regeneron continues to push the boundaries of science to create life-changing medicines for people with serious diseases worldwide, we're evolving our capabilities to cultivate a culture of safety, environmental stewardship, and compliance. In this newly formed role as Director of Occupational Toxicology, you will provide robust, scientifically-sound hazard analysis, risk profiles, and risk mitigation strategies for novel therapeutics handled in our laboratory, scale-up, and manufacturing settings. Success in this role will require partnering with our EHS teams and key stakeholders across Regeneron to support the evolution of our occupational toxicology programs and business strategies. This role is based at our Corporate Research HQ in Tarrytown, NY and is not open to remote assignments As Director EHS, Occupational Toxicology, a typical day may include: Responsible for development and life cycle management of ADEs, OELs, and SDS documentation, including risk...

We are seeking a detailed oriented and highly motivated Senior Scientist to join the Immunology team within Regeneron Genetic Medicines, supporting research focused on the unique immunological challenges of gene therapy and other genetic medicines. You will spearhead projects investigating innate and adaptive immune responses to genetic medicine platforms, such as viral vectors (e.g. adeno-associated viruses/AAV), virus-like particles (VLPs), RNA therapeutics (RNAi/ASO/AOCs), lipid nanoparticles (LNP), and other next-generation modalities. In conjunction with these studies, you will develop and evaluate novel immunomodulation and immune tolerance technologies designed to manage undesired anti-drug, anti-vector, and anti-transgene immune responses. This work will also use Regeneron’s core suite of technologies, including VelocImmune-derived fully-human antibodies and VelociGene mouse models. As a Senior Scientist, a typical day might include: Independently planning and...

We are seeking an Associate Scientist to join our Non-viral Delivery Technology group and support screening potent and tolerable gene delivery modalities. As a part of Regeneron Genetics Medicine, this work would involve lipid nanoparticle (LNP)-nucleic acid formulation, characterization, and optimization, as well as assisting in development of novel LNP characterization assays. Your nanoparticle expertise combined with Regeneron’s technology platforms, including viral and non-viral gene therapy, CRISPR-mediated gene editing, VelociGene transgenic mouse models, and the extensive catalog of fully human therapeutic antibodies, will be applied to make immediate contributions to the field of next-generation genetic medicine. As an Associate Scientist, a typical day may include the following: Performing, analyzing, and troubleshooting LNP characterization assays such as nucleic acid encapsulation efficiency (Ribogreen), sizing (DLS), surface properties (zeta potential), and...

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,...