- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. The Associate Director , Clinical Programming must have expertise in addressing technical ... will be responsible for implementing new technological solutions for end users.The Associate Director , Clinical Programming manages and oversees JReview… more
- Merck & Co. (Boston, MA)
- …to manage clinical development projects; and assist the Executive Director and/or Associate Vice President in ensuring that appropriate Corporate ... Atherosclerosis & Metabolism medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will manage the entire… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Experience Qualifications 7 or More Years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development or ... authoring, and management of Dose Preparation Instructions in support of clinical studies being conducted globally by Daiichi Sankyo. The candidate will… more
- Merck & Co. (North Wales, PA)
- …individuals who are passionate about driving impactful changes. Position Overview: As the Associate Director of Launch Strategy and Operations, you will lead the ... IndicatedValid Driving License:NoHazardous Material(s):n/aRequired Skills:Adaptability, Adaptability, Agile Methodology, Agile Project Management, Biopharmaceuticals, Biotechnology, Business, Clinical Immunology,… more
- Merck & Co. (South San Francisco, CA)
- …the Data, AI and Genome Sciences (DAGS)-Department is recruiting-an Associate Director , Computational Biology-in-Cardiometabolic Drug-Discovery-Data Sciences. We ... data to support drug discovery in the cardiometabolic disease space. The Associate Director will inform discovery, translational medicine, companion diagnostics… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams.Responsibilities: Study Strategy: Provides the ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...and oversee completion of clinical trial protocols. Provides… more
- Eisai, Inc (Exton, PA)
- …technology transfer to external partners (as required). The Associate Director sets strategic directions and project priorities, providing scientific ... your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and...in development through their lifecycle (Preclinical through phase III clinical development) at the Biologics Pilot Plant as well… more
- Genmab (NJ)
- …feel like a fit? Then we would love to have you join us!The RoleThe Associate Director , External Data Quality Management, is a strategic leadership role within ... Clinical Data Management. This individual is accountable for driving...for inspection readiness, regulatory compliance, and successful data submissions.The Associate Director will lead cross-functional collaboration, provide… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary:The Associate Director , Oncology Value & Market Dynamics Training Manager is ... barriers/opportunities to access for patients across our portfolio of products. The Associate Director will develop, in partnership with other key stakeholders,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Associate Director , Laboratory Data Management is accountable for the end-to-end ... delivery of laboratory data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and other vendors to… more
- Merck & Co. (Rahway, NJ)
- …across technical transfer initiatives, working collaboratively with the Senior Director , Directors, and Associate Directors, and cross-functional teams.Utilize ... across inline program support projects, working collaboratively with the Senior Director , Directors, Associate Directors, and cross-functional teams.- Ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of a CDx study/IVDR performance evaluation study integration of an assay into clinical testing (before testing) and once data is ready for CDx submission (after ... to external diagnostic business partners specifically:Use of CTA/CDx within clinical trialsDevice protocols and SAPsDevice non-significant/significant risk determinations (both… more
- Genmab (NJ)
- …competitive landscape) that represent operational risks for the execution of clinical trials within the given indication/program.Key contributor to the study's ... in data analysis and interpretation to inform strategic decision making, project management, developing study delivery strategies and tactical operational plans… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team and serves ... as ad hoc member to the Global Project Team for late stage projects. This position manages...technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …this job is to provide statistical programming technical support to DSI project teams on all statistical programming deliverables and programming submission. It will ... and build up standard on SDTM/ADaM datasets, and TFLs.Responsibilities:- Supporting project lead on outsourced projects, act as statistical programming subject… more
- Merck & Co. (Rahway, NJ)
- …costs, executing contracts and ongoing contract management. This role will report to the Associate Director , Clinical Trial Central Labs to support high ... Position Description: The selected candidate will provide procurement support for Clinical Development Sourcing and Procurement (CDSP) in C linical Trial Central… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is accountable ... QA RDPVQA, and oversees multiple levels of direct reports (Directors, Associate Directors, Managers, contractors as applicable) across the Global Quality teams… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for marketed products Track applications through FDA reviewing divisions Work with project associate on compilation of information and supportive documentation ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...Position Manage and oversee all assigned projects/products/processes. Assist the Director in assuring Novo Nordisk compliance with internal SOPs… more
- IQVIA (Durham, NC)
- …job is located. IQVIA's Cardiovascular, Renal and Metabolic (CVRM) team are looking for an Associate Clinical Project Director to work across our growing ... obesity portfolio. Associate Clinical Project Management Directors manage and support the operational elements and execution of studies and/or programs to… more
- IQVIA (Philadelphia, PA)
- *Home-based position Our Associate Directors in Clinical Project Management manage and support the operational elements and execution of studies and/or ... in life sciences or related field with 10 years clinical research experience and 5-7 years global project... clinical research experience and 5-7 years global project management experience + In-depth therapeutic knowledge in one… more
