72 jobs found in Bernards, NJ

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 Manager, Vendor & Relationship Management (VRM) provides support to the operational requirements for which VRM has accountability to ensure optimal functionality and business operations within VRM along with support of the overall delivery of the Vendor Engagement life cycle.    This position will have key interactions with partnering functions within REGN as well as with external partners. ​Leads, on behalf VRM, the document collection and analysis of Governance and Oversight Compliance. A Typical Day Might Look Like this: Manage and document the tiering of Global Development Vendors in collaboration with VRM staff and relevant functions Measure and manage the application of Partnership Effectiveness framework and behaviors across Global Development Support generation and continuous improvement of VRM metrics, including additional support needed to each Segment on applicable Vendor/segment specific dashboards Leads and oversees the creation,...

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 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...

With guidance, an Associate Manager, Drug Development Program Management (DPM) uses program management knowledge and experience in the drug development industry to provide operational leadership and manage components of development program(s). You will contribute to the cross functional development team (Strategic Program Team) to develop strategic plans including goals, budgets, timelines and track the execution of these plans from preclinical through commercialization/lifecycle management.  This role has a 3-day onsite requirement in either Tarrytown, NY or Basking Ridge NJ. This role is not eligible to fully remote work. A typical day as an Associate Manager in DPM looks like: Project Planning and Execution: Assist in the development and maintenance of integrated project plans, timelines, and budgets for drug development programs. Plan, track and manage project milestones, dependencies and critical path through existing project management planning systems and...

Using prior program management knowledge and experience in the drug development industry, the Sr. Manager Development Program Management provides operational direction as the leader for one or more development programs [within a given Therapeutic Area]. The Sr. Manager Development Program Management executes the strategic direction of a program from preclinical through commercialization by driving the development and implementation of integrated [project] program plans, goals, budgets, and timelines.   The Sr. Manager Development Program Management is responsible for forming and managing effective cross functional teams and leads a network of functional area project managers. A typical day as a Sr Mgr in Development Program Management looks like: SCOPE: Supports development of a program throughout its lifecycle, by integrating key stakeholders from Discovery, Manufacturing, Preclinical, Global Development and Commercial. Independently manages multiple development...

A Manager, Development Program Management (DPM) uses program management knowledge and experience in the drug development industry to provide operational leadership and manage components of development program(s).   This individual contributes to the cross functional development team (Strategic Program Team) to develop strategic plans including goals, budgets, timelines and track the execution of these plans from preclinical through commercialization/lifecycle management.   A typical day as a Manager in DPM looks like: Development Teams: Under the direction of their manager or DPM Lead, supports select subteam and/or functional area meetings. May lead functional area and/or working group meetings.  Participates in development of risk management plans.  Tracks deliverables, risks, and issues. Business Acumen:   Under direction of their manager or DPM Lead, Identifies stakeholders across organization to facilitate cross functional reviews/alignments of key...

As a Senior Manager, Global Procurement you will be accountable for supporting the definition and implementation of the global Clinical Core (IRT, eCOA) and Digital Health Technology Category strategy. We work closely with team members managing discussions and aligning category priorities with Procurement management and collaborators. A typical day may include:   Managing negotiations, supplier management activities, and collaborator engagement activities.  Collaborating driving value in terms of cost savings, cash flow improvement, and other efficiency savings from category management activities. Representing Global Procurement by participating in organizational decisions in the Clinical Core (IRT, eCOA) and Digital Health Technology categories with critical short and long-term impact on the success, efficiency, growth, and results. Demonstrates knowledge of efficient global procurement organizations and processes within the biopharmaceutical industry to support the growth and...

As a Sr. Manager Global Procurement you will support and assist in the development and implementation of the our Global Clinical Category Management strategy by gathering and anticipating business supply needs and specifications. We aim to manage a supply base and enhance value, minimize risk, and ensure quality & cost effectiveness by working collaboratively with business unit.  A typical day may include the following:  •    Collaborating with partners leading discussions related to the Global Clinical Category strategies and aligns category priorities.  •    Manages negotiations, supplier management activities, and partner engagement activities •    Drives value in terms of cost savings, cash flow improvement, and other efficiency savings.  •    Represents Global Procurement by participating in organizational decisions in Global strategies with critical short and long-term impact on the success, efficiency, growth, and results. •    Demonstrates knowledge of efficient...

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 or Armonk, NY. 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 oversight (as required) for the...

This role entails leading more complex and proactive global monitoring and surveillance of changes in the regulatory landscape focused on drug development lifecycle starting from preclinical through commercialization.  This position will also serve as a lead Reg Intel contact in support of cross-functional requests and initiatives from the Global Clinical Development organization and various functions within the organization’s GxP framework.   In this role, a typical day might include: Project Management and leadership in the delivery of regulatory intelligence research services and information Collaborating on the development and refinement of regulatory intelligence processes and procedures to build efficiencies with more senior leaders...

As a Senior Specialist, Global Procurement you will support the planning and execution of procurement initiatives using the procure to contract process for Regulatory Affairs & Health Economics and Outcomes Research. This position will conduct data gathering, support spend analytics, assist in delivering measurable cost savings, and monitor savings against contract. You will support evaluations through the development of RFQs, RFIs and RFPs, collectively RFx, and may participate in negotiations. The Senior Specialist will support all vendor sourcing activities which includes but is not limited to preparing QBR data and measuring supplier performance.  A typical day may include the following: Works to support procurement and category management-related initiatives.  Use sourcing system tools and techniques to meet business needs and issues while supporting collaborators and category teams. Provides comparative financial analysis when required for sourcing & procurement...

Regeneron leads with science and our global procurement team will play a critical role in enabling our scientific advancements. Our vision is to build a procurement capability that acts as a competitive advantage to Regeneron. This is a great opportunity to join us and help to shape and drive the development of the new organization and realize our vision. Key Accountabilities: Accountable for leading, defining, and implementing the global Clinical Laboratories Category strategy to serve global and regional business needs. Works closely with stakeholders to lead discussions related to the Clinical Laboratories Categories and aligns category priorities with Procurement management and stakeholders. Leads negotiations, supplier management activities, and stakeholder engagement activities for the Clinical Laboratories Category  as assigned. Works independently to drive value in terms of cost savings, cash flow improvement, and other efficiency savings from category...

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology. The flagship product—an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFRCT Analysis—provides a color-coded, 3D model of a patient’s coronary arteries indicating the impact blockages have on blood flow to the heart. Heartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMap™Analysis), assess coronary blood flow (FFRCT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis). Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare. Heartflow is a publicly traded company (HTFL) that has received international recognition for exceptional strides in healthcare...

CMS At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions. ZOLL Cardiac Management Solutions offers a unique portfolio of novel technologies designed to deliver better insights and better outcomes. On any given day, clinicians utilize these ZOLL products for tens of thousands of cardiac patients around the world: LifeVest , the world's first wearable defibrillator, has been trusted to protect more than 1M patients at risk of sudden cardiac death. HFMS (Heart Failure Management system) is a non-invasive, patch-based device that monitors pulmonary fluid levels and has been shown to reduce heart failure readmissions rates by 38 percent. TherOx Super Saturated Oxygen (SSO2) Therapy is the first...

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at  www.axsome.com  and follow us on  LinkedIn  and  X . About This Role Axsome Therapeutics is...

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at  www.axsome.com  and follow us on  LinkedIn  and  X . About This Role Axsome Therapeutics is...

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at  www.axsome.com  and follow us on  LinkedIn  and  X . About This Role Axsome Therapeutics is...

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at  www.axsome.com  and follow us on  LinkedIn  and  X . About This Role Axsome Therapeutics is...

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.       JOB DESCRIPTION: Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Free medical coverage for employees* via the Health Investment Plan (HIP) PPO. An excellent retirement savings plan with high employer contribution. Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company...