55 jobs found in Bridgeport, CT

The Regeneron GVP Quality Management Lead (QML) is a key position that we believe will guide and lead all aspects of quality and compliance within global pharmacovigilance (PV) system. We expect the Sr. Manager to build strategic partnerships and direct risk-based quality management activities with key partners impacting the global Regeneron PV system. Furthermore, the GVP QML Sr. Manager will be responsible for supporting inspection readiness at all times. The GVP QML will partner with other members of the Global Development Quality Governance and Oversight (GDQGO) department to identify trends through metrics in order to diagnose and remediate systemic quality issues. In this role, a typical day might include the following: Responsible for leading GVP-compliant activities from a quality perspective in conjunction with business and Associate Director / Director, GVP QML Engage with, support and liaise with multiple cross-functional collaborators whose work impacts the...

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:...

We are seeking a highly motivated Senior Manager, Business Operations Cost Management, who will be responsible for cost management activities regarding running clinical trials.   The Senior Manager, Business Operations Cost Management, will work at the portfolio, program and functional levels to provide prospective and retrospective measurements of cost, productivity, efficiency, and quality to facilitate informed decision making for Regeneron’s clinical development portfolio.  The Senior Manager, Cost Management will act as a business partner providing critical business operations support to GD, Development Operations & Portfolio Management (DO&PM) functional leadership, Procurement and Finance. This role has a 3-day onsite minimum requirement in one of our office locations. This role is NOT eligible fully remote. Relocation assistance will be provided to those who qualify. A typical day in this role as a Sr Manager looks like: Understand how CROs apply...

The Project Manager provides support for complex cross-functional strategic projects as directed by Senior Project Managers or Program Managers. The Project Manager will support driving and delivering results per charter goals, managing scope, schedule, quality, resources, risk and value/ benefit.  The Project Manager will also manage medium to small projects independently for the business or internal to the function with oversight by more seasoned Program/Project Managers or leadership. A Typical Day Might Look Like this: Plan, manage, execute and deliver a project through its lifecycle within the approved scope, schedule and budget  Secures acceptance and approval of deliverables and perceived value from the Project Lead and Stakeholders  Estimates and coordinates project resources  Maintains the Project Charter, schedule, issues log, budget and risk management plan Manages the risk register and the escalation of risks and issues. Partners with Change...

About Ceribell Ceribell is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions. The Ceribell System is a novel, point-of-care electroencephalography (“EEG”) platform specifically designed to address the unmet needs of patients in the acute care setting, and is being used in hundreds of community hospitals, large academic facilities and major IDN's across the country. Our entire team is driven by a shared commitment to transforming the landscape of critical care through our rapid seizure detection technology, come join the movement! Position Overview This role must be based within the region.   Remote applicants will not fit the requirements. The candidate is responsible for department expansions and new product launches within a region, with the existing Ceribell customer base into ED, ICU, Neonatal, and future indications.You will partner closely with the Clinical Account Manager...

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...

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...

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...

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...

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...