10 jobs found in Bernards, NJ

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...