- Merck & Co. (Rahway, NJ)
- …Atherosclerosis & Metabolism medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will manage the ... monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May Be Responsible For: Evaluating pre- clinical and… more
- Merck & Co. (Rahway, NJ)
- …teams and the operational/executional arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary ... effectively communicate with stakeholders at various levels, including cross-functional teams, senior management, external vendors, and clinical sites. Strong… more
- Merck & Co. (North Wales, PA)
- …clinical data/medical protocol deviations in collaborations with the Clinical Director .Other responsibilities include:Collaborating cross-functionally in the ... writing, and presentation skillsEducation/ExperienceBachelor's Degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical… more
- Eisai, Inc (Nutley, NJ)
- …programming and JReview within IODS. Reporting to the Assoc. Director of Clinical Programming is the senior level highly technical SAS and JReview ... If this is your profile, we want to hear from you. The Associate Director , Clinical Programming must have expertise in addressing technical challenges in the… more
- Merck & Co. (Rahway, NJ)
- …and fusion proteins. Within Mixed Modality, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose ... opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of robust compositions,… more
- Merck & Co. (South San Francisco, CA)
- …space. This work will help to inform discovery, translational medicine, companion diagnostics and clinical research. The Senior Director will also serve as a ... and Genome Sciences (DAGS). Our department is recruiting a Senior Director , who will serve as the...in discovery, being innovative and foreseeing the path to clinical trialLeverage scRNASeq to contextualize target gene expression in… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director , Biologics to lead all Chemistry, Manufacturing, and Controls ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …execute daily production schedules.Will have 3-6 direct reports ranging from Associate Director , Senior Manager, and Manager.Oversee the hiring, development, and ... in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations...production of a personalized cell therapy to support both clinical and commercial requirements in either a Grade C… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ED&AA, IT, Ethics and Compliance, Commercial, Patient Services, CMR ( Clinical , Medical, Regulatory), Finance, and Novo Nordisk global colleagues. Externally, ... IT teams to ensure a strong data and technology foundation Engage senior leaders to drive strategic technology transformations Physical Requirements 10-20% overnight… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the ... Collaboration and partnership with other functions and stakeholders in supporting clinical trial monitoring and execution through RBQM activities. Accountable for… 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 ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole Summary Under the guidance of an Executive Director , has primary responsibility for developing value evidence strategies, and planning/managing ... resource utilization and costs, physician and patient satisfaction surveys, clinical and patient reported outcomes assessments, systematic reviews and meta-analyses,… 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
- Merck & Co. (Rahway, NJ)
- …pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research ... with superior product quality and allow speedy progression for clinical studies and commercial launch. The candidate will be...or downstream areas) or manufacturing is required; ability to project achievable project plans to ensure effective… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Senior Engineer in Device Design and Process Development group, you will be part of our Research & Development team that designs and develops ... benchtop/low-volume to high-volume clinical and commercial assembly equipment and processes for medical...processes for medical devices/drug delivery systems. Reporting to the Director responsible for this area, you will partake in… 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
- Kymera Therapeutics (Watertown, MA)
- …that our people are valued, seen, and heard. How you'll make an impact: The Senior Director , Clinical Operations is a leadership role responsible for ... phases of clinical trials (Phase I-III). The Senior Director will be a leader in...trials across a key immunology program in accordance with project timelines, budget, and quality standards Develop and manage… more
- ADC Therapeutics SA (New Providence, NJ)
- Position: Senior Director , Global Clinical Quality Assurance Location: Hybrid/Remote (New Providence, NJ) Transforming what patients can expect from cancer ... culture, please visit us at https://adctherapeutics.com/ and LinkedIn. Position Overview: As the Senior Director of Global Clinical Quality Assurance, this… more
- Eli Lilly and Company (Boston, MA)
- …value for our partners and patients. Purpose of the Role: The Director [commensurate with experience], ExploR&D Translational Medicine incumbent is responsible for ... right candidate the opportunity to provide leadership in early phase clinical development on multiple exciting programs, working with external biotechnology… more
- Recursion (New York, NY)
- …data sets, and sophisticated analytics. We are seeking a highly motivated and skilled Senior Clinical Project Manager within our Clinical Operations ... to study closure with support or direction from a Director of Clinical Operations. In this role,...industry, with at least 3+ years experience in a clinical project management role within a biotech… more
