- Merck & Co. (Rahway, NJ)
- … development teams and the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary ... - Project Management Skills: strong knowledge of the principles of project management and clinical customer relationship management. - Technical Proficiency:… more
- Merck & Co. (Rahway, NJ)
- …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
- Merck & Co. (Rahway, NJ)
- …and will interact externally with key opinion leaders.-Specifically, the Executive Director may be responsible for:Evaluating pre- clinical and translational work ... opportunities.Managing other Directors and/or Senior Directors responsible for Atherosclerosis clinical development projectsThe Executive Director may supervise… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a highly skilled and motivated Associate Principal Scientist/ Associate Director with expertise in conducting outcome ... models to extract meaningful insights and outcome research evidence. Unstructured Clinical Data: Utilize transfer learning, fine tuning, GAN, transformer, attention,… more
- Merck & Co. (Rahway, NJ)
- …Adaptability, Applied Engineering, Automation Systems, Business, Capital Project Management, Change Management, Chemical Manufacturing, Clinical ... Job DescriptionAbout the Role:-As a Technical Lead, you will report into Director , Chemical Technical Operations, External Manufacturing API Technology, and play a… 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
- 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
- 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
- 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
- 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
- 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)
- …function as the main point of contact to the Dx partner for CDx project contracts. Supports CDx analytical and clinical validation studies in collaboration with ... of companion diagnostics (CDx) strategy in support of projects and Global Project Teams within Daiichi Sankyo's Early and Late-Stage Development Portfolio. The… 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
- 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 (Parsippany, NJ)
- *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
- Merck (Rahway, NJ)
- … development teams and the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary ... + Project Management Skills: strong knowledge of the principles of project management and clinical customer relationship management. + Technical Proficiency:… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Statistical Project Leader ( Associate Director ) **Location:** Morristown, NJ , Cambridge, MA **About the job** Are you ready to shape the ... teams accelerate progress. Join our Biostatistics Immunology & Inflammation as Statistical Project Leader ( Associate Director ) and you'll provide statistical… more
- Bristol Myers Squibb (Princeton, NJ)
- …This position will be based in San Diego, CA or Lawrenceville, NJ. **Summary:** The Associate Director , Clinical Data Management, will play a crucial role in ... in clinical systems, including EDC, IVRS, CTMS, eTMF, and other clinical project management tools; ability to learn new systems as needed. + Contribute to… more
