57 management jobs found in Armonk, NY

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:...

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 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...

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 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...

As a Director, Health Economics and Outcomes Research, Immunology you will work with HEOR’s center of excellence and cross-functional partners formulating our strategies, plans and studies. We develop and implement global and regional HEOR strategies and programs to inform, support and strengthen commercialization activities, including clinical development, marketing, and market access This position will require you to be on-site for 3+ days/week at our Sleepy Hollow, NY offices. If eligible, we can offer relocations assistance. We do not have the option for a fully remote position. A typical day may include the following:  •    Collaborate with our Alliance partner on HEOR plans, studies, and projects; build and maintain constructive and positive relationships across Alliance. •    Lead and collaborate with HEOR subject matter experts to develop and implement evidence generation plans supporting clinical development and value demonstration.  •    Partner with cross...

As a Senior Director, HEOR you will be responsible for leading HEOR-Epidemiology activities to inform, support, and strengthen global development and commercialization activities for our products within our General Medical area. Drawing on your expertise in epidemiologic study design and methods as well as on your knowledge of real-world data, you will design, conduct, and reporting of real-world evidence (RWE) studies. It is expected to have current epidemiologic methods and work effectively in a cross-functional environment. This is a Sleepy Hollow, NY office-based position with requirements to be on-site for a minimum of 3 days/week. If eligible, we can offer relocation benefits. We are unable to offer a fully remote option for this position. A typical day may include the following: •    Conducting observational research, using large electronic healthcare databases to generate a better understanding of disease and real-world outcomes •    Developing and/or reviewing...

The Senior Medical Director, Obesity Global Medical Affairs provides strategic leadership with high visibility in the organization, reporting into the Executive Director of General Medicine, Global Medical Affairs. The Sr Medical Director orchestrates the development of medical strategy, planning and execution of medical affairs activities at Regeneron with the benefit of the patient at the forefront. They provide strategic planning and execution leadership by thoroughly understanding relevant the disease, ongoing development programs, market dynamics, as well as priorities and serve as a scientific and medical resources. The Senior Medical Director leads a multifunctional Medical Impact Team (MIT) within a matrix organization, consisting of colleagues within the medical affairs organization. They ensure alignment working closely with research & development, commercial, access & reimbursement, and patient advocacy colleagues and represents Regeneron towards collaborators...

Regeneron’s responsibility strategy focuses on using the company’s unique knowledge and expertise to build resiliency and improve our world. This newly created position will play a key role in advancing Regeneron’s long-standing commitment to responsible business practices, sustainability and transparency. Performance measurement is essential to driving progress towards our responsibility goals. This position will be responsible for managing all aspects related to environmental, social and governance (ESG) data collection, analysis and verification. Importantly, this includes establishing processes and controls that are appropriate as well as scalable for future growth. ESG key performance indicators (KPIs) can cover topics such as: access to medicines, environmental sustainability, responsible supply chain, and community giving. This person will work with internal stakeholders across all levels of our global organization to align on accountabilities and identify and...

As an Associate Director, Medical Affairs Insights & Analytics you will provide valuable strategic insight and actionable recommendations to our therapeutic area teams supporting our development of medical impact plans. This position supports and advises collaborators on how best to develop research studies applying research reports while developing annual medical plans. We also determine how to measure progress against goals.  A typical day may include:   Collaborating with cross-functional teams developing comprehensive insights plans supporting our medical affairs strategies and initiatives.  Communicating and aligning with partners around market research and analytics objectives and outputs  Leading primary market research design and execution to answer key medical insights questions within priority therapeutic areas Synthesizing and translating data and information into compelling insights and recommendations.  Championing insight approaches and analytic methods,...

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...