111 jobs found in Bernards, NJ

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:...

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.   Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).   Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To...

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.   Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).   Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration....

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.   Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).   Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To...

We are looking to add an Executive Director Quality Control to our team in Rensselaer, NY! This role leads activities in Quality Control, including but not limited to: release and in-process testing, stability testing, lab investigations, manufacturing failure investigations, environmental monitoring and microbiological testing. Providing comprehensive testing support to clinical and commercial manufacturing, regulatory inspections, filing and facility operations. Leading operational and technological collaboration between the QC group and its business partners. In this role, a typical day might include the following: Leading a full scale of QC operation to support production, facility and cGMP compliance. Providing broad experience and guidance for biopharmaceutical quality control and analytical testing. Interpreting scientific data and draw reasonable conclusions. Advising manufacturing, QA, RA, facilities and material management of quality control requirements and...

We are currently looking to fill a Sr/ Executive Director, GMP Data Governance & Integrity position. This position is responsible for the Regeneron Industrial Operations and Product Supply (IOPS) Data Governance and Integrity program. Directs and leads the activities of team. Works closely with business leaders and department subject matter experts to implement data integrity standards into business operations. Serves as the global leader on good practices for their area. Develops and delivers effective training and education programs; works with the business to embed practical steps into procedures, processes and other documentation. In this role, a typical day might include the following: Business Priorities: Global owner and lead for Data Governance and Integrity – defines the standard and ensures broad understanding and integration across the business Partners with personnel to define or revise associated business processes to meet defined standards; applies...

The Process & Procedures (P&P) Lead, Director is responsible for the end-to-end procedure development lifecycle. The Director role is responsible for collective multiple partner groups, understanding interdependencies and overall efficiencies through process optimization. We require the Director to act as a thought partner to support process effectiveness related to compliance and standard processes. We expect a great level of business insight, critical and thinking to support management of sophisticated issues that demand interaction with senior leadership in a highly matrixed environment. Process/Procedure development includes interpreting global and country specific functional business regulatory requirements and industry standards to deliver a portfolio of controlled procedural documents. The role will provide procedural expertise and work across multiple functions in Global Development to identify cross-functional dependencies and ensure project timelines are met. We...

This is a hybrid position on-site 3 non-consecutive days in Armonk, NY or Basking Ridge, NJ. The Director, Strategy Planning & Operations will partner with the functional VP(s)/Functional Head(s) and their Senior Leadership Teams (SLTs) to lead the development and execution of functional & corporate-level strategic initiatives, setting objectives and goals, resource & finance management, cross-functional alignment, issue identification, mitigation and resolution, while driving operational efficiencies. This role enables the vision and mission of an impactful, strategic, and quality-focused function that is well-aligned cross functionally, internal and external to Development Operations, Portfolio Management, and Biostatistics & Data Management (DO, PM & BDM) and Global Development (GD). This role collaborates with other GD Strategy Planning and Operations staff and functional SLTs, to drive value and strategic evolution of the specified organization. This...

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 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, Vendor Management, is responsible for assessing, onboarding, and overseeing the health and performance of vendors involved in clinical trial execution. This role ensures that vendors meet the necessary qualifications and compliance standards, manage relationships, and oversee delivery to time, cost, and quality. This position is capable of leadership and oversight of vendor segments, and of the technical aspects such as quality, compliance, business continuity, and inspection readiness. This position is expected to have the ability to execute a variety of roles to meet the expectations of effective relationship management and driving compliance and high-quality delivery.   Relationship Management Oversee the performance and health of vendors within assigned segment to ensure deliver to plan – time, budget quality. Develop/enhance vendor performance scorecards that drives identification of mitigations/contingencies against performance...

Account Director, Medical Communications Overview eNova, an IQVIA business, is a next-generation medical communications agency. Our mission is to transform medical communications by connecting HCPs and stakeholders across the healthcare ecosystem with content that advances science and medicine. We are currently seeking an experienced Account Director to join our team in support of both new and existing client relationships.The Account Director is responsible for the management and delivery of engagements within their portfolio, and is a key relationship driver for our client accounts. Essential Functions Business Growth Partner with clients to identify traditional and innovative solutions that drive brand growth which translate to organic growth for eNOVA, actively participate in strategic brand and tactical planning and contribute to the development of tactical plans Client Management Serve as primary liaison to the client and agency team for all...

Position Summary The Business Development Director will play a pivotal role in driving strategic growth and revenue generation for IQVIA’s Market Access Technology and Services (MATS) practice. This leader will be responsible for identifying and capitalizing on market opportunities, cultivating executive-level client relationships, and delivering tailored, tech-enabled solutions that address complex commercialization and market access challenges across the pharmaceutical, biotech, and med-tech industries. This role combines strategic sales leadership, deep industry expertise, and cross-functional collaboration to expand IQVIA’s footprint in the life sciences market access space. Key Responsibilities Drive net-new business development across assigned territories, verticals, or solution suites. Develop and execute strategic account plans to build long-term client relationships and drive revenue growth. Identify and analyze market trends, client needs, and competitive...

Job Title: National Account Director-Vaccines Location: Remote/Field About the Job The Director, National Accounts develops and manages strategic partnerships, high quality B2B relationships, and contractual agreements with Sanofi Pasteur’s high-value customers. Assigned customers and partnerships developed have regional/national scope, significant market impact (both direct and indirect influence) and establish market access (supply and contract/pricing nationally) to Sanofi Vaccines products creating a platform to maximize vaccine sales within all customer segments. This position is a REMOTE role. This position is responsible for achieving/exceeding sales and marketing objectives across the high dollar value/dose volume customers with strategic value within National Health Systems.  Directors, National Accounts are expected to acquire and maintain expertise in brand/segment strategy and tactics, product knowledge, contracting and pricing platforms, membership...

Job Description: As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our ‘people first’ philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world’s oldest enemy: disease. Our ambition is for our novel, first-in-class treatment for bladder cancer to become the new standard of care and backbone therapy for patients across the non-muscle invasive bladder cancer (NMIBC) disease spectrum. In 2024, our intravesical gene therapy achieved over 1,500 patients treated across the country at most major medical centers and community care...

Position Summary The Business Development Director will play a pivotal role in driving strategic growth and revenue generation for IQVIA’s Market Access Technology and Services (MATS) practice. This leader will be responsible for identifying and capitalizing on market opportunities, cultivating executive-level client relationships, and delivering tailored, tech-enabled solutions that address complex commercialization and market access challenges across the pharmaceutical, biotech, and med-tech industries. This role combines strategic sales leadership, deep industry expertise, and cross-functional collaboration to expand IQVIA’s footprint in the life sciences market access space. Key Responsibilities Drive net-new business development across assigned territories, verticals, or solution suites. Develop and execute strategic account plans to build long-term client relationships and drive revenue growth. Identify and analyze market trends, client needs, and competitive...

TITLE: MARKET DIRECTOR NE QUALIFICATIONS: • Bachelor’s degree– four-year degree from accredited reputable institution • Experience leading managers, high performing capital and disposable teams selling disruptive technology • A minimum of 8 years of experience within sales, five years’ capital sales management, and/or training or marketing organization is required • High level of technical/clinical product knowledge • Strong organizational and communication skills • Must have proven track record of participation leading/teaching at organizational meetings. • Excellent communication skills and the ability to work as a cross-functional team member is required, presentation (platform) skills are required, proven ability to be a self-starter and goal oriented is required • Excellent interpersonal, written, and oral communication skills are required • Must thrive in complex environment and be able to multi-task and prioritize • Strong local relationships within...

CORE RESPONSIBILITIES Formulate and execute a high-impact sales strategy for increased placements of the Robotic System, collaborating with senior leadership and providing strategic content for sales meetings. Partner with the Senior Director of Sales to establish metrics for monitoring and enhancing sales performance, emphasizing sustainable growth through targeted resource deployment. Drive field activities to expand placements, manage resources effectively, and cultivate key relationships within facilities to establish strong corporate partnerships. Lead achievement of sales goals by providing clinical expertise, contributing to the enhancement of Company's marketplace reputation. Provide regular updates on competition, product use, clinical updates, and key business metrics to the Senior Director of Sales. Conduct frequent field visits to support sales execution, facilitate team professional development, and deliver compelling executive presentations to...

TITLE: MARKET DIRECTOR NE QUALIFICATIONS: • Bachelor’s degree– four-year degree from accredited reputable institution • Experience leading managers, high performing capital and disposable teams selling disruptive technology • A minimum of 8 years of experience within sales, five years’ capital sales management, and/or training or marketing organization is required • High level of technical/clinical product knowledge • Strong organizational and communication skills • Must have proven track record of participation leading/teaching at organizational meetings. • Excellent communication skills and the ability to work as a cross-functional team member is required, presentation (platform) skills are required, proven ability to be a self-starter and goal oriented is required • Excellent interpersonal, written, and oral communication skills are required • Must thrive in complex environment and be able to multi-task and prioritize • Strong local relationships within...