- 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)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …authoring, and management of Dose Preparation Instructions in support of clinical studies being conducted globally by Daiichi Sankyo. The candidate will ... collaborate globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC, and Clinical Development to collate the necessary… 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
- Merck & Co. (Boston, MA)
- …to manage clinical development projects; and assist the Executive Director and/or Associate Vice President in ensuring that appropriate Corporate ... medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will... development (pre- clinical to post-licensure). The Senior Director will manage the entire cycle of late-stage … more
- Eisai, Inc (Exton, PA)
- …difference. If this is your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading ... well as supporting technology transfer to external partners (as required). The Associate Director sets strategic directions and project priorities, providing… 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
- 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
- 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)
- …research areas centered around rare diseases and immune disorders. Summary: The Associate Director , Laboratory Data Management is accountable for the end-to-end ... of laboratory data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and other vendors to ensure… 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 ... Job DescriptionAssociate Director , Launch Strategy and OperationsLocation: North Wales (Upper Gwynedd), PennsylvaniaDivision: Human Health US (HH-US)Therapeutic… more
- Eisai, Inc (Boston, MA)
- …from you. The Data Operations Group at Eisai, Inc. is looking for Associate Director - Data Scientist/Programmer to create insightful AI powered instantaneous ... and non-technical audiences.Eisai Salary Transparency Language:The base salary range for the Associate Director , Data Scientist & Data Operations is from… 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)
- …to support submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting- ... and ensure effective implementation of SDTM, ADaM and TLFs standard in clinical trial data analysis- Develop and maintain necessary programming macros or tools… 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 ... an increasingly complex matrix environment. Strong understanding of all aspects of clinical drug development, with particular emphasis on clinical trial design,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements ... laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some… 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 ... including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review. Acts as main statistical contact for the assigned studies and… 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)
- …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
- Eisai, Inc (Pittsburgh, PA)
- …with internal cross functional partners including but not limited to Associate Director Regional Marketing, Oncology Field Reimbursement Managers, and ... decision-makers through understanding of issues and opportunities in territory. Deliver clinical , efficacy, and safety messaging and information about product access… more
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