- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with DS standards. The Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO, 3rd Party Vendor Management and ... Has primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including critical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead . Responsibilities:Study Strategy: Clinical study leader (CSL) ... and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO;… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead . ResponsibilitiesStudy Strategy: Clinical study leader (CSL) ... and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO;… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Summary This position is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This role is primarily responsible for ... streams with key service providers and working with internal departments to progress clinical supply projects. Every effort has been made to identify the essential… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …employer including veterans and people with disabilities. SummaryThis position will be the Clinical Science Group Lead in late phase development in the Global ... the Senior Director level for each respective program. This Clinical Science (CS) Group Lead will be responsible for overseeing multiple program-level CS Asset… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies, conduct hands on ... for all aspects of clinical pharmacology and biopharmaceutics studies; clinical pharmacology project lead ; supports Phase 2/3 clinical … more
- Merck & Co. (North Wales, PA)
- …including those new to the organization therefore requiring someone who has built and lead clinical development plans from the ground up. They will also be ... Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Ophthalmology will focus on driving strategy, development, and… more
- Merck & Co. (North Wales, PA)
- …/scientific execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on a clinical trial team.Leading medical ... the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position,...monitoring team in review and interpretation of clinical data/medical protocol deviations in collaborations with the … more
- Merck & Co. (Rahway, NJ)
- …Center in Rahway is looking for an Associate Director - Process Engineer to lead clinical supply manufacturing, scientific rigor of processes, and ultimately to ... is a multi-modality (small molecule, biologics, vaccine) Drug Product development and clinical manufacturing facility in Rahway, New Jersey.- This team works with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …needed- Clinical Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of ... development and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of the other sections in collaboration with the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …needed Clinical Development Expertise Strategy: In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of ... development and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of the other sections in collaboration with the… more
- BioAgilytix (San Diego, CA)
- …support; escalate issues and advise solutions as necessary.Centralize, streamline, and boost clinical kit processes so that lead times, redundancy, and margin ... you enable life-changing, life-saving therapeutics to the patients who need them.The Clinical Kit Coordinator is responsible for supporting the Clinical Kit… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Team. In addition, he or she will interact with the Companion Diagnostics Lead , Non- Clinical Research, Medical Affairs and other stakeholders to support the ... enumerate key translational hypothesis that will drive scientific decision-making both from non- clinical and clinical translational aspects. In doing so, he or… more
- Insmed Incorporated (San Diego, CA)
- …Medical Director of Ophthalmology, Clinical Development holds the responsibility to lead clinical programs across different diseases and supervising the ... trials, through to full development.Serve as the therapeutic area lead of the ophthalmology clinical development team,...the therapeutic area lead of the ophthalmology clinical development team, partnering closely with heads of … more
- Eisai, Inc (Nutley, NJ)
- …evidence (RWE) development programs in support of global market access initiatives. Lead clinical meaningfulness initiatives that address issues such as payer ... a pharmaceutical company in Nutley, NJ. Assess real-world data gaps and lead evidence generation process for the collection and dissemination of information, data,… more
- Merck & Co. (Rahway, NJ)
- …will be required to ensure effective utilization of the facility in support of clinical development.- -The Production Lead is the steward of this key our ... provides a launch pad for the commercial formulation development and GMP clinical supply manufacture of our company's drug product pipeline.- The FLEx Non-Sterile… 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)
- …rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all ... and Medical Access/Expanded Access (MAP)/(EAP)activities in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …systems, tools, processes, policies and procedures to support and lead to informed, fact based sourcing decisionsPhysical Requirements10-20% overnight travel ... of the following is preferred: Market Research, Data & Analytics, Clinical OperationsPharmaceutical industry experience helpful, but not requiredAbility to exert… more
- Merck & Co. (Rahway, NJ)
- …provide resources and services that are critical to the success of Global Clinical Trial Operations (GCTO) and Global Clinical Development (GCD) objectives and ... are developed to meet those identified needs.Evaluates and advises clinical teams on strategy of adding a new supplier...or other initiatives to meet business needsMay plan and lead the transition activities related to managing an existing… more
