- Merck & Co. (Rahway, NJ)
- …clinical data /medical protocol deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct/indirect team members ... and prioritization skillsAdvanced analytical skills with the ability to interpret clinical trial data and synthesize conclusionsInteract with key stakeholders… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Director , Clinical Scientist This position drives scientific planning, strategy and execution of Phase 1-4 ... of clinical data /medical protocol-deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct and indirect team… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director , Business Analyst, within Metrics, Analytics & Performance (MAP) will lead activities related to the development, delivery, ... 10%Flexible Work Arrangements:Not ApplicableShift:1st - DayValid Driving License:NoHazardous Material(s):NoRequired Skills: Clinical Trials, Dashboard Reporting, Data Literacy, Metrics… more
- Merck & Co. (Rahway, NJ)
- …BS degree in relevant discipline.-Knowledge and Skills:--Minimum 6 years' experience in Clinical Data Management or Pharmacovigilance as appropriate to business ... Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide...teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs,… 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
- Merck & Co. (Rahway, NJ)
- …build and lead a team of TA dedicated global and regional directors and associate directors. The Executive Director , Value & Implementation (referred to as EDMA) ... Job DescriptionThe Executive Director , Value & Implementation (V&I), Global Medical and...guides TA scientific exchange (input and output) and real-world data generation of all Research & Development (R&D) V&I… 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
- Merck & Co. (Rahway, NJ)
- …approach, driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… 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
- 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
- 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
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Associate Director , Precision Medicine Clinical Laboratory Operations will be responsible for Clinical Laboratory Project & Program management for ... laboratories to support early and late-stage programs within our pipeline. **As an Associate Director , a typical day may include the following:** + Perform… more
- Bristol Myers Squibb (Summit, NJ)
- …+ Advanced Degree in related field (MS, Ph.D. or PharmD) + For Associate Director level with Ph.D. approximately 5+ years experience with demonstrated ... and pharmacometric support for all pipeline assets throughout the clinical development lifecycle. Composed of pharmacologists, pharmacometricians, data … more
- Merck (Rahway, NJ)
- **Job Description** **Position Description:** ** Associate Director , Clinical Scientist** This position drives scientific planning, strategy and execution of ... of clinical data /medical protocol deviations in collaboration with the Clinical Director . + Builds talent and capabilities of direct and indirect team… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …of hard copy and/or electronic solutions for data acquisition in MTPA clinical development studies. The Associate Director functions in a department ... evidence, and creating hope for all facing illness. The Associate Director , Data Management is...and leads all operational aspects of the projects in Clinical Data Management. **Responsibilities** + Responsible for… more
