- Genmab (Plainsboro, NJ)
- …essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be responsible for leading the development ... and maintenance of global labeling documents (eg, Core Data Sheet, USPI, EU SmPC and related patient information)...Regulatory Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the head of Clinical , medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...internal stakeholders. In the execution of specific projects, the Associate Director , will be accountable for managing… more
- Genmab (Plainsboro, NJ)
- …for Genmab products. Perform ongoing surveillance (including signal detection/evaluation) of safety data from Genmab clinical trials. Be the primary safety ... Informed Consent, and Development Safety Update Reports. Establish and manage external Data monitoring Committees (DMCs) for early phase trials. Contribute to the… more
- Genmab (Plainsboro, NJ)
- …and/or as trial responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and ... to be our best, and authentic is essential to fulfilling our purpose.The RoleThe Associate Director acts as a statistical expert supporting the clinical … more
- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.The Role & DepartmentThe Associate Director , Vendor Management, will play a pivotal role in managing ... the relationships with the clinical vendors as well as coordinate and manage outsourcing...of internal and external stakeholders (eg Scientists, Trial Managers, Data Managers, Clinicians, vendors) to support the overall development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Coast Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Non- ... and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct… more
- Genmab (Plainsboro, NJ)
- …will report to the Director , Programming, and work closely with Data Management, Clinical Programming, Statistics, Medical Writing, and other functions as ... essential to fulfilling our purpose.The Role & Department As a Senior Programming Associate or Programming Manager, you will be in the Statistical Programming team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a comprehensive understanding of the functional roles within Pharmacovigilance and Clinical TrialsAbility to extract configurable data fields from a ... of Daiichi Sankyo Pharmacovigilance Safety systems, and fulfillment of data change requests. ResponsibilitiesChange Requests for PV Systems Collaborate cross… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders.SummaryThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple ... surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional team in support of benefit risk… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory ... Liaisons to ensure successful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review of documents supporting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical trials preferred- Demonstrated ability to leverage digital data and analytics preferred- Demonstrated ability driving or participating in digital ... procurement for Global RD - for their specific categories.- Data Analysis Based Decision-Making- Uses rigorous analyses of ...or More Years Outsourcing, health sciences or related field ( clinical trials) required- 7 or More Years Deep experience… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core ... Data Sheets (CCDS) for assigned products. This position drives/leads...all applicable regulations and guidelines and with Company Core Data Sheets and manages deviations. This position interacts across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data .Drug...with data manager to ensure high quality data .Drug Development Strategy: Provides input to multiple aspects of… more
- Sumitomo Pharma (Trenton, NJ)
- …seeking a dynamic, highly motivated, and experienced individual for the position of Associate Director , elluminate (R) Data Programming. This role will ... Duties and** **Responsibilities** + Assist in development and delivery of a clinical data strategy that allows the organization to be resilient and responsive to… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data ... (SOPs) within assigned program(s). The PDML is a member of the Clinical Data Management extended leadership team, and as such interacts with senior level… more
- Bristol Myers Squibb (Princeton, NJ)
- …sustainability and success of the BMS R&D pipeline. This role reports to the Director , Clinical Data Management or Associate Director , Clinical ... treatment we pioneer. Join us and make a difference. The Senior Manager, Clinical Data Management ( Data Management Lead) is a role considered essential to… more
- Bristol Myers Squibb (Princeton, NJ)
- …design, development and implementation of technical solutions for integrating, analyzing and reporting clinical data . Associate Director drives the ... development and implementation of innovative strategies and technologies for clinical trial programming. Associate Director ...medical terminology used in the analysis and submission of clinical data + Broad expertise in statistical… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …studies and ensures scientific integrity and interpretation of study data of a clinical development program. The Associate Director leads in a matrix ... join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads...and designs mitigation strategies + Promotes consistent first line medical/ clinical data review techniques and conventions across… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Associate Director , Clinical Sciences contributes to the development, evaluation, planning and execution of hematology clinical studies and ensures ... on clinical studies and programs. As an Associate Director , a typical day may include...and designs mitigation strategies + Promotes consistent first line medical/ clinical data review techniques and conventions across… more
