73 jobs found in Tarrytown, 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...

As the Head of Publications (Executive Director) you will lead a team of publication managers and writers. We strive to ensure the quality and timely execution of publication projects while driving innovative approaches enabling broad scientific share of voice.  We will deliver strategic development and targeted delivery of clinical and HEOR global publications across all therapeutic areas. This will be across the life span of our assets in a heavily matrixed and scientifically interdependent environment. We have the need to drive a vision for the future that will involve creating efficiencies, showing tangible impact and measurement beyond traditional metrics and transcend beyond typical channels of communication. This position is located in Sleepy Hollow, NY and will require you to be on-site for a minimum of 3 days/week. We do not have a fully remote option for this position. If eligible, we can offer relocation benefits. A typical day may include the following:...

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 Associate Director, Strategic Analysis will be responsible for formulating and articulating insights about unmet medical needs and the external landscape to help advise key research, clinical development and commercialization decisions for the Internal Medicine therapeutic focus area.  You will have input on assets spanning the Internal Medicine portfolio, and in partnership with senior leaders, will influence strategic alignment around key development decisions including: advancing the development of assets; indication selection; clinical trial design; and regulatory path. This high visibility role requires strong communication skills and the ability to distill complex insights to senior leaders throughout the organization, including the executive team. At Regeneron, you will be an important member of an innovative team where your contributions will help drive the success of the company.  This is a great opportunity to support the strategic roadmap for one of our most...

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...

This is a hybrid position on-site a minimum of 3 non-consective days in Tarrytown, NY or Basking Ridge, NJ is required. A fully remote role is not possible. We are seeking a highly experienced and dynamic Senior Director Development Project Manager to join our team. The successful candidate will primarily be responsible for identifying and developing a team of manager through associate director ready program managers.  Additionally, the successful candidate will provide operational leadership, direction, and support to assigned small and/or low to medium complexity development program(s). This is a new leadership role within the department that requires strong people management and talent development skills, strategic thinking, excellent leadership skills and a proven track record in project and program management within the biotechnology or pharmaceutical industry. In a typical day, you will: Recruit, hire, build and lead a team of high performing, early-career program...

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...

Leads the Chemistry, Manufacturing, and Controls (CMC) non-antibody team for cell and gene therapy technologies. The candidate will be responsible for assuring development and execution of global regulatory strategies for assigned cell and gene therapy   portfolios. This role includes overseeing regulatory affairs staff, various outside contractors, supporting project teams and development partners and leading Health Authority activities. In this role, a typical day might include: Direct activities of assigned Regulatory Affairs team with emphasis on global regulatory strategy and the preparation, review, and submission of documents for FDA, EMA and other regulatory authorities. Establish operational objectives and work plans and appropriately delegate to team setting the priority for the workload Provide leadership with input about departmental strategy, organizational goals, and current policies Provide and drive strategic and operational global CMC...

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 Global Patient Safety (GPS) Lead role (Director of GPS) serves as the first point of contact (POC) for all safety related issues for the compound(s) [asset(s)] assigned within a given therapeutic area (TA), and is the GPS representative on the cross functional strategic program team (SPT) for the compound. The GPS Lead leads the safety strategy and ensures the optimal support from within GPS and works collaboratively with stakeholders to deliver the safety strategy. This position requires the ability to work with and influence colleagues in a matrix environment within and external to GPS including senior management. The GPS Director joins Regeneron’s industry leading scientific organization, and has a direct impact on drug development, operations, and commercialization in all relevant global territories. In this role, a typical day might include: This Director position is directly responsible for all aspects of Global Patient Safety activities for assigned...