- 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
- 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
- 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)
- …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
- 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)
- …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. (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
- 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
- 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
- Actalent (Basking Ridge, NJ)
- Job Title: Associate Director Clinical Operations Job Description Align with the Head of Clinical Development Operations or Senior Director , ... at the program and franchise levels and may represent Clinical Operations on the Strategy and Portfolio or ...+ Must have a current or previous title of Associate Director / Director . Additional Skills &… 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …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. (Basking Ridge, NJ)
- …Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. **Responsibilities** + Study Strategy: ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...oversee completion of clinical trial protocols.… more
- IQVIA (Parsippany, NJ)
- …guide and inform the monthly investigator payment forecast cycle and support project finance requirements, including a review of accruals, costs incurred, contracts ... focus. + Proven record of results working with senior management. + Strong project management skills and the ability to translate business challenges into financial… more
