Company Detail

Regeneron Pharmaceuticals Inc
Member Since,
Login to View contact details
Login

About Company

Job Openings

  • Director, Biostatistics - Genetic Medicine  

    - Cambridge
    Regeneron is seeking a Director, Biostatistics to join our team!This p... Read More
    Regeneron is seeking a Director, Biostatistics to join our team!This position is for a qualified statistician/biostatistician to support Clinical Biostatistics within Global Development. This position requires an individual with a strong background in biostatistics, exceptional leadership capabilities, and the ability to contribute meaningfully to drug development and regulatory strategies while fostering collaboration and innovation across teams.Please note: This is a 4 day onsite opportunity on a weekly cadence. If you are not local and qualify, Regeneron can offer a relocation package.This role might be for you if can/haveLead and/or oversee the 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 interpret the results and make decisions appropriately. The incumbent will work with Strategic Project Teams on clinical and regulatory strategies for the clinical development strategy and 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 a Director, the incumbent will be responsible for mentoring and overseeing less experienced statisticians and working with those statisticians to ensure other programs are properly supported, with the potential to manage full-time staff.In this role, a typical day might include:Cross-Functional Collaboration:Represent Biostatistics in Strategic Project Teams and Global Clinical Sub teamsPartner with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical Scientists, Statistical Programming, Data Management, and Medical Writing to design and analyze clinical trials.Ensure clinical programs are appropriately structured for success.Regulatory Contributions:Guide staff in preparing materials for regulatory interactions, including analysis plans, tables, figures, and listings (TFLs) for submissions and advisory committee meetings.Co-present findings to regulatory agencies and management.Process and Methodology Development:Identify gaps in processes and lead working groups to implement improvements.Develop and revise SOPs and contribute to cross-functional workstreams.Lead research teams to establish new statistical methodologies as needed.Communication and Training:Prepare presentations and reports to effectively communicate statistical findings to project teams, management, and regulatory bodies.Deliver training programs to enhance statistical understanding among non-statistical colleagues.Leadership and Mentorship:Mentor and oversee junior statisticians, ensuring adequate support for other programs.Potentially manage full-time staff and oversee their professional development.To be considered for this opportunity, you must have the following:PhD in Statistics/Biostatistics with over 8 years of pharmaceutical industry experience (or MS in Statistics/Biostatistics with over 13 years). A PhD is strongly preferred.Preferred experience in the fields of rare disease, neurodegenerative disease or gene therapy.In-depth knowledge of drug discovery and development, with the ability to integrate statistical concepts into strategic decision-making.Strong leadership and influence skills, with a proven ability to collaborate effectively in cross-functional teams.Demonstrated critical thinking, time management, and communication skills to thrive in a fast-paced, collaborative environment.#GDBDMJobs Read Less
  • Senior Manager, Biostatistics - Thrombosis  

    - Cambridge
    Regeneron is looking for a Senior Manager to join our Biostatistics te... Read More
    Regeneron is looking for a Senior Manager to join our Biostatistics team!In this role, a typical day might include:This position is for a qualified statistician/biostatistician to support Clinical Biostatistics within Global Development. 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 participate in regulatory agency meetings. 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, lead the development of new infrastructure and processes, and influence the external pharmaceutical industry and regulatory environment through active participation in professional associations, conferences, and publications. As a Senior Manager, the incumbent will be responsible for mentoring and overseeing less experienced statisticians, with the potential to manage contract staff. This role might be for you if you can/have: ​Interacts with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, Medical Writing, and others to design and analyze clinical trials.Develops individual protocols and statistical analysis plans and determines appropriate statistical methodology for data analysis.Collaborates with Statistical Programming on the programming of tables, figures and listings to support decision making and for regulatory reporting. Evaluates appropriateness of available software for planned analyses and determines needs for use of novel statistical methodology or tools.Analyzes data and interprets results from clinical trials and of data from non-trial sources to facilitate program-level decision making. Prepares presentations and written reports to effectively communicate results to the project team, management, and regulatory agencies. Co-presents findings to management. Is involved in research activities for innovative statistical methods and applications in clinical trial development as well as providing training to non-statisticians. To be considered for this opportunity, you must have the following: ​PhD or equivalent degree in statistics/biostatistics with >4 years’ experience in the pharmaceutical industry, or MS degree in statistics/biostatistics with >9 years’ experience. Knowledge of drug discovery and development and ability to integrate statistical concepts into drug discovery and development strategies.Excellent influence and leadership skills, and a demonstrated ability to collaborate in a cross-functional environment. Must be able to work productively in a fast-paced collaborative environment, with demonstrated critical thinking skills, time management skills, and effective communication skills.Solid knowledge of statistical analysis methodologies, experimental and clinical trial designExpertise in statistical software such as R or SAS is required#GDBDMJobs Read Less
  • Regeneron is seeking a Director, Biostatistics to join our team!This p... Read More
    Regeneron is seeking a Director, Biostatistics to join our team!This position is for a qualified statistician/biostatistician to support Clinical Biostatistics within Global Development. This position requires an individual with a strong background in biostatistics, exceptional leadership capabilities, and the ability to contribute meaningfully to drug development and regulatory strategies while fostering collaboration and innovation across teams.Please note: This is a 4 day onsite opportunity on a weekly cadence. If you are not local and qualify, Regeneron can offer a relocation package.This role might be for you if can/haveLead and/or oversee the 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 interpret the results and make decisions appropriately. The incumbent will work with Strategic Project Teams on clinical and regulatory strategies for the clinical development strategy and 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 a Director, the incumbent will be responsible for mentoring and overseeing less experienced statisticians and working with those statisticians to ensure other programs are properly supported, with the potential to manage full-time staff.In this role, a typical day might include:Cross-Functional Collaboration:Represent Biostatistics in Strategic Project Teams and Global Clinical Sub teamsPartner with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical Scientists, Statistical Programming, Data Management, and Medical Writing to design and analyze clinical trials.Ensure clinical programs are appropriately structured for success.Regulatory Contributions:Guide staff in preparing materials for regulatory interactions, including analysis plans, tables, figures, and listings (TFLs) for submissions and advisory committee meetings.Co-present findings to regulatory agencies and management.Process and Methodology Development:Identify gaps in processes and lead working groups to implement improvements.Develop and revise SOPs and contribute to cross-functional workstreams.Lead research teams to establish new statistical methodologies as needed.Communication and Training:Prepare presentations and reports to effectively communicate statistical findings to project teams, management, and regulatory bodies.Deliver training programs to enhance statistical understanding among non-statistical colleagues.Leadership and Mentorship:Mentor and oversee junior statisticians, ensuring adequate support for other programs.Potentially manage full-time staff and oversee their professional development.To be considered for this opportunity, you must have the following:PhD in Statistics/Biostatistics with over 8 years of pharmaceutical industry experience (or MS in Statistics/Biostatistics with over 13 years). A PhD is strongly preferred.Preferred experience in the fields of rare disease, neurodegenerative disease or gene therapy.In-depth knowledge of drug discovery and development, with the ability to integrate statistical concepts into strategic decision-making.Strong leadership and influence skills, with a proven ability to collaborate effectively in cross-functional teams.Demonstrated critical thinking, time management, and communication skills to thrive in a fast-paced, collaborative environment.#GDBDMJobs Read Less
  • Director, PV Enablement  

    - Cambridge
    Regeneron's Global Patient Safety Organization is looking for a Direct... Read More
    Regeneron's Global Patient Safety Organization is looking for a Director, PV Enablement to join the team!!In this role, a typical day might include:The Director of PV Enablement will report directly to the VP of Global Patient Safety (GPS) Operations. This role is pivotal in shaping the delivery of pharmacovigilance (PV) governance to ensure operational requirements are met within a growing global PV platform.In coordination with the Vice President (VP) of GPS Operations, provide strategic oversight and deliver global PV governance in partnership with the GPS Leadership Team (GPS LT). Develop and maintain operational reporting dashboards and provide status oversight for key GPS project initiatives in collaboration with the VP of GPS Operations. Partner with cross-functional teams, including Development Operations, Portfolio Management, and Biostatistics/Data Management, to establish operational portfolio forecasting for GPS.Offer strategic, holistic support for GPS interfaces to enable PV operations and ensure alignment across functions. Lead operational excellence optimization activities, including benchmarking PV innovation and capabilities, as assigned. Identify and assess operational risks across all areas of GPS, ensuring proactive mitigation strategies are in place.This role might be for you if you can/have:This enablement role is accountable for demonstrating pharmacovigilance (PV) technical expertise and leadership, working collaboratively with key stakeholders to perform the following essential functions:Strategic PV Operations Oversight and Governance: In coordination with the Vice President (VP) of GPS Operations, provide strategic oversight and ensure the effective delivery of global PV governance within the Global Patient Safety (GPS) organization and leadership team. Operational Reporting and Forecasting: Implement an operational reporting dashboard and oversee the status of key GPS project initiatives by partnering with the VP of GPS Operations to ensure the effective delivery of portfolio requirements. Collaborate with cross-functional teams—including Development Operations, Portfolio Management, and Biostatistics/Data Management—to establish operational portfolio forecasting.Support for GPS Interfaces: Offer strategic and holistic support to GPS interfaces to enable PV operational alignment and effectiveness. Operational Excellence: Lead operational excellence initiatives, including benchmarking PV innovation and capabilities, as assigned. Holistically identify and assess GPS operational risks, supporting inspection readiness in collaboration with team stakeholders and relevant areas. Regulatory Compliance and Safety Initiatives: Ensure the successful execution of safety initiatives, maintain regulatory compliance, and drive continuous process improvements within the GPS organization. Cross-Functional Collaboration: Act as a key liaison between the PV department and other functions, including Regulatory Affairs, Development Quality, and Regeneron. Resource Management and Operational Planning: Provide strategic oversight to develop and implement resource management plans, focusing on efficiency of operational requirements within GPS. Planning and Execution Improvement: Oversee and apply a systematic approach, using structured methodologies, to continuously improve planning processes and operational execution. Identify strategic priorities in partnership with the VP to optimize workflows, maximize delivery efficiency, and enhance overall effectiveness. Operational Optimization and Broader Partnerships: Actively participate in operational optimization activities by collaborating with Regulatory Affairs, Global Patient Safety, Development Quality, and Global Development teams. Leadership and Team Development: Manage ambiguity and translate challenges into tangible outputs and opportunities for the department. Contribute to an enriching team environment that supports GPS culture, capability growth and team development, both as a team member and individually, in alignment with the values of the Regeneron Way. To be considered for this opportunity, you must have the following:Minimum Bachelor's Degree with 12+ years of relevant PV planning and operations experience in the pharmaceutical area and specific industry experience in managing and providing oversight of operations within a global patient safety organization highly preferred.Function as a subject matter expert in global pharmacovigilance for GPS operations and planning.A proven ability to lead and develop a diverse remit in a constructive, goal-oriented environment, with continuous improvement and innovation mindset.Demonstrated problem-solving with the ability to “flex” across different complexities, business situations and cross functional partners of global patient safetySuccess in effectively utilizing PV technical expertise along with communicating and influencing decisions with all levels of an organization and delivering high quality work.Demonstrated ability and track-record to lead PV operational and planning initiatives with excellence, including governance activities.#GDPSJobs Read Less
  • Director, Privacy Counsel  

    - Cambridge
    As a key member of the Privacy Office in Regeneron’s Law Department, t... Read More
    As a key member of the Privacy Office in Regeneron’s Law Department, this role will enable our rapidly growing and globally expanding business to develop and execute on innovative data-driven strategies in accordance with data privacy and related laws. The successful candidate will effectively partner with Law Department colleagues and other functions at Regeneron, provide expert and pragmatic counseling to senior leaders, and provide leadership and subject matter expertise to drive the continued improvement and implementation of Regeneron’s data privacy program.This role can be based at Regeneron's offices in Cambridge, MA or Sleepy Hollow, NY (4 days a week onsite) - it is not open to hybrid or fully remote assignments.A typical day might include:Providing advice and counseling on a wide range of privacy and related issues such as advising on sensitive data, digital advertising, and use of emerging technologies/AI.Strategically assess potential privacy risks on new projects, including risk-mitigation counseling and advising on appropriate controls.Monitoring emerging regulations and supporting the operationalization of compliance with evolving laws.Upkeep and development of internal policies, procedures, and guidance documents; educating business clients through training and awareness programs; Improving and counseling on privacy program operations.Working with Regeneron’s Privacy Steward Council to drive initiatives that enhance data privacy across the organization.Collaborating with our Government Affairs division on opportunities to influence legislation.Assisting contracting teams in drafting, maintaining, and negotiating data processing agreements.Participating in industry group meetings to stay updated on best practices and emerging trends.This role might be for you if you have:Strong knowledge of local and global privacy laws and their application to the pharmaceutical/biotechnology industry.Deep understanding of privacy risks associated with ad tech and emerging technologies.Excellent relationship building skills.Demonstrated ability to work collaboratively and with all levels of the workforce.Exceptional oral, written, and presentation communication skills, with the ability to effectively communicate and translate legal analysis to business counsel to a varied audience.High level of business acumen, influencing skills and ability to drive change.You are willing to take on a leadership role in an important, dynamic and challenging field.To be considered for this role, you must have a JD and be licensed to practice law in New York (or eligible for licensure as a registered in-house counsel). 5-7 years of legal experience at a law firm and/or in-house, and at least 3 years of experience in privacy. Ad Tech, Biotechnology, pharmaceutical or related life science experience is strongly preferred. Read Less
  • Regeneron Pharmaceuticals is seeking a highly experienced transactions... Read More
    Regeneron Pharmaceuticals is seeking a highly experienced transactions attorney for a pivotal role to serve as the liaison to the Regeneron Data Privacy Office. This position will act as a privacy expert within the Transactions & Contracts team offering guidance to colleagues on privacy law and ensuring that privacy provisions are seamlessly integrated into our contracts. The position involves drafting, reviewing, negotiating, and providing strategic counsel on a diverse portfolio of agreements across our innovative business units.Your expertise will be instrumental in advising the Transactions Team on complex privacy issues, requiring a deep understanding of life sciences, business transactions, and data privacy. We are looking for a candidate with exceptional drafting and negotiation skills, and a proven track record of progressive experience in contract law and data privacy. The ideal candidate thrives in collaborative settings, working alongside multiple stakeholders to provide comprehensive legal solutions that drive Regeneron's success.The role will be based onsite at our offices in Cambridge, MA or Sleepy Hollow, NY. This is not open to fully remote-based work arrangements. If eligible, we can offer relocation benefits.
    A typical day might include the following:Providing legal support for a particular area of business transactions, which may include research collaboration agreements, master services agreements, consulting services agreements, license agreements, data use agreements, laboratory services agreements and confidentiality agreements, among others.Maintaining subject matter expertise in data privacy laws and the Regeneron privacy policies and advising Transaction Law colleagues and clients on developments of importance.Providing ongoing one-on-one support to members of the Transaction Law team and coordinating with internal teams and external resources to negotiate and finalize data privacy language in third-party agreements.Responding to U.S. and ex-U.S. contracting questions.Managing updates to group’s data privacy contracting playbook.Creating data privacy contracting tools and training materials.Managing office hours with internal business partners.Developing and training on privacy contracting tools and requirements.Acting as liaison for the Transactions Law Group with the Data Privacy Office on data privacy policy questions and approaches.
    This role might be for you if:You have the ability to work independently, while meeting aggressive deadlines and juggling multiple matters.You are able to maintain an objective perspective while developing and maintaining strong partnerships with key stakeholder / client organizations and protecting Regeneron’s interests.You can work effectively and professionally with colleagues and clients at all levels of the organization and in a collaborative, team-oriented environment.You have the ability to effectively convey to, and respond to questions from, colleagues and key stakeholders, on data privacy law concepts. 
    To be considered for this position you must possess a JD with excellent law school credentials. Licensed to practice law in New York or be eligible for licensure as a registered in-house counsel is preferred. At least 7 years of legal experience at a law firm and/or in-house, with some biotech/pharmaceutical and/or health care experience is preferred. Solid understanding of contracts and related law. Experience with contracts involving data privacy and intellectual property. You should also have a high level of business acumen, excellent contract drafting and negotiation proficiency, exceptional oral and written communication skills and interpersonal and conflict resolution capability. Read Less
  • For US Locations, this position is on-site 4 days per week and 1 day f... Read More
    For US Locations, this position is on-site 4 days per week and 1 day from home. For Uxbridge and Dublin, colleagues must be on-site 3 days per week and 2 days from home. A fully remote role is not possible for this position. The Program Operations Leader (POL) is responsible for leadership of and setting and implementation of 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 has responsibility for staff recruitment, development, coaching, mentoring and performance management. Plays a key role in driving the functional strategy of Clinical Trial Management in partnership with Functional leadership. The Director POL is expected to operate with autonomy and high-degree of independence.In a typical day, you will:Be responsible for the overall success of the clinical study team(s) within a program(s)Maintain an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level updates to stakeholders as requestedProvide operational insight into feasibility, timeline and cost estimates during clinical program/study developmentOversee clinical study timelines within a clinical program(s)Provide input and operational insight into Clinical Study Concepts (CSC)Be responsible for development and implementation of operational strategy, driving early study planning budget and timelines from Clinical Study Concept through Final Protocol Review plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases of studies. Ensure consistency within the program and development of best practices within CTMOversee clinical study budgets within a program: ensures review, presentation and approval of initial study budget and manages the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriateEnsure timely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s). Drive decision making and integrates all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementationAct as point of contact for clinical program and study level escalationReview key metrics and Key Performance Indicators (KPIs) across studies and within clinical program(s) to track study progressProvide proactive creation and implementation of risk mitigation strategiesProvide innovative and flexible operational solutions and options to the cross functional and development teams; assists in preparing scenarios for creative solutions to operational challengesDrives the strategy and oversight for vendor selection and management within a clinical program(s)Manages the Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level deliverables and relationship with key CRO (functional and project) and vendor counterpartsMay require up to 25% travelTo be considered, you must possess a Bachelor's degree and a minimum of 12 years of related in-house sponsor-side pharmaceutical experience, with 8 years in clinical operations. Read Less

Company Detail

  • Is Email Verified
    No
  • Total Employees
  • Established In
  • Current jobs

Google Map

For Jobseekers
For Employers
Contact Us
Astrid-Lindgren-Weg 12 38229 Salzgitter Germany