64 executive jobs found in Sleepy Hollow, NY

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...

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 is a global leader and pioneer in ophthalmology research and has market-leading drugs for the treatment of retinal diseases. The Eylea brand is approved for the treatment of several retinal disorders and is the market category leader in the anti-vascular endothelial growth factor (anti-VEGF) class for these disorders. Beyond Eylea, Regeneron is committed to research with other mechanisms of actions and modalities for the treatment of a variety of other ophthalmological disorders. Regeneron Global Medical Affairs is organized in an optimally aligned matrix structure for the delivery of therapeutic and functional area expertise. Our medical affairs physicians and scientists are experts on our medicines and form an extremely valuable part of our global development organization. They serve as important contacts between Regeneron and the scientific and healthcare community. The Head of Medical Affairs for Ophthalmology will report to the Head of Internal Medicine for...

The Medical Director, Clinical Sciences should be a qualified physician with pharmaceutical industry experience, preferably in Ophthalmology Therapeutics Development. The Director will serve as Medical Lead for clinical trials in the CDP and is responsible for the design of clinical study concepts leading to clinical trial protocols. This role requires a high-performing and highly passionate physician scientist who serves as a clinical role model for the team and demonstrates outstanding clinical scientific knowledge applicable to clinical research. As a Medical Director, a typical day may include the following responsibilities: Acts as medical expert and leader in interactions with external stakeholders Defines clinical trial-related Clinical Development Program (CDP) goals and objectives  Works closely with discovery teams to provide input on the next generation of targets in the field Responsible for the relevance and accuracy of medical science underpinning...

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...

Seeking experienced, rigorous, and innovative leader to head Regeneron’s Molecular Profiling Computational Data Sciences research team, consisting of approximately 35 dynamic researchers supporting all therapeutic areas, core technology groups and clinical development units at Regeneron in the design, generation and interpretation of high dimensional data sets from key platform technologies such as single cell RNA sequencing, bulk RNA sequencing, TCR/BCR sequencing and spatial transcriptomics. The position plays a key role in furthering Regeneron’s ability to advance our understanding of novel targets and biological pathways from discovery to clinical development.  Successful candidate would direct and inspire the Data Sciences team by using their deep and broad expertise in the computational biological sciences to set strategic vision, suggest novel technological approaches, and critically evaluate data and projects. Candidate would be expected to participate in...

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 Senior Medical Director, Clinical Sciences, Endocrinology, will play a key role in clinical development programs within the General Medicine portfolio focused on obesity and related comorbidities. This role serves as Scientific and Medical Lead for Clinical team(s) working closely with Operational Leads to guide and execute clinical development strategies and subsequent regulatory submissions. This role requires a high-performing and highly passionate individual who serves as a clinical role model for the team and demonstrates outstanding clinical scientific knowledge applicable to clinical research. The Senior Medical Director General Medicine reports to an Executive Director, General Medicine. A typical day may include the following: Acts as medical expert and leader in interactions with external stakeholders Develops unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape. Designs 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,...

The Clinical Imaging Scientific Director for Oncology will own the strategy and execution of sophisticated early and late phase oncology imaging in clinical trials where imaging plays a key role. Imaging includes all modalities with a special focus on PET and CT. In this role, you will champion the development of imaging endpoints and biomarkers and drive the scientific imaging aspects and tumor response assessment of oncology clinical studies. This position provides excellent opportunities to develop innovative imaging endpoints and biomarkers in support of clinical development and to contribute to bringing new treatment options to patients. As a Director in Clinical Imaging, a typical day may include the following: Create fit-for-purpose imaging biomarker strategies and work closely with research and clinical imaging, the oncology therapeutic area for the development of imaging endpoints to inform and advance the Regeneron clinical pipeline Prepare and present...

We are currently seeking an established leader for the Regeneron Genetic Medicines (RGM) research chemistry group. In this position, they will play a key role in building out RGM’s chemistry group, to combine the company’s existing expertise in biologics with novel genetic medicines modalities, including, but not limited to oligonucleotides and lipid nanoparticles (LNPs). Their team will be primarily composed of synthetic and conjugation chemists and work in a highly collaborative environment with other technology and biology groups. Successful candidates may have a synthetic/conjugation chemistry and/or genetic medicines targeting background. We expect they will act as an inspiring leader to apply solutions and develop novel technologies to address challenges related to genetic medicines' delivery, and oligonucleotide/lipid nanoparticle synthesis and conjugation. A day in the life of a Senior Director Oligonucleotid Chemistry may look like: Directly supervise and...

The Director, Clinical Sciences, Oncology 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 candidate development projects through early and/or late phase development. The Director reports to the Senior Director, Clinical Sciences, Oncology and collaborates closely with Medical Director(s) (MDs) to provide scientific expertise necessary to design and deliver on clinical studies and programs. Responsible to manage a team of clinical scientists. As a Director in Clinical Sciences, 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 Guides assigned Program team(s)/direct reports and serves as a line Manager for CS team and serves as key...

We are seeking an Associate Director to join out Oncology Clinical Development department. The Associate 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 Associate Director 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 Associate Director reports to the 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 an Associate 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 Contributes to program team meetings, scientific advisory boards, study...

The Medical Director, Clinical Sciences functions as clinical leader of a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase), under leadership of Program Lead Medical Director (Program Lead MD) or Sr. Medical Director. As a Medical Director, a typical day may include the following: Provides clinical leadership and responsible for all clinical deliverables within the assigned section of a clinical program with minimal supervision from Program Lead MD. Manages all operational aspects and drives execution of the section of the clinical program in partnership with global line functions, assigned Clinical Scientist and Clinical Operations associates. Supports Program Lead MD (and/or Sr. MD) and frequently lead interactions with external collaborators (e.g., regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups), internal collaborators (e.g., Research, Early Clinical...

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 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 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 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 an Associate Director for the Research and Pre-Clinical Development (R&pD) Lab Consumables team, specifically responsible for the Bioreagents subcategory creation, management, and execution. This role involves developing and leading strategies for our subcategories, as well as leading and implementing strategic sourcing initiatives. This role will coordinate the development of sourcing specifications, requirements, and scopes of work for RFIs, RFQs, and RFPs. They will gather and assess data through benchmarking, market intelligence reports, and Voice of the Customer (VoC) interviews, and perform analytics on spend, inventory levels, utilization, and KPI measurements. Additionally, delivering measurable cost savings for their category of spend. They will actively participate in supplier selection and relationship management, providing data-driven recommendations to management for informed decision-making. This role manages risk, develops strong business...