- Tris Pharma (Monmouth Junction, NJ)
- …or science related field and minimum 10 years Clinical Operations and/or Clinical Trial Management experience in a pharmaceutical, biotechnology, ... in our Monmouth Junction, NJ location for a Senior Director , Clinical Operations.The Senior Director ,...Conference on Harmonistaion (ICH) guidelines and regulatory requirements for clinical trial management Current working… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …on clinical programs in scope/portfolio.Close collaboration with Asset and Portfolio Management (APM), GCO Clinical Trial Business Operations (CTBO), and ... centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management... Operations VP and is accountable for ensuring the clinical trial portfolio and submissions are delivered… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …best practices within capacity planning, reporting and overall performance metrics for clinical trial reporting Physical Requirements Up to 10% overnight travel ... required; Advanced degree preferred A minimum of 10 years' progressively responsible clinical trial experience within a pharmaceutical, biotechnology, CRO and/or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... Planning and Execution: Provides input on major milestones of trial , clinical trial plan and...trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …delivery to US and CA warehouses operations for US and CA Clinical Trial sites. Accountable for overall performance management of Senior Supply team, who ... deliverables across NACD. This includes leading processes and technology improvements to link Clinical trial site needs, Finance and Supply forecasts that will… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …& Development. Internal relationships include working with Headquarters, NA CMR including Clinical Trial Management , Medical Affairs, Regulatory Affairs and ... including NNI Evidence Generation Plans and Product Development Plans Clinical study management : Provide regional medical &...expert medical community input Regulatory liaison: Write and/or review clinical sections of clinical trial … more
- Eisai, Inc (NJ)
- … provides strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for products ... If this is your profile, we want to hear from you. The Medical Director , US Medical Affairs provides medical leadership for medical affairs strategy, planning and… more
- Eisai, Inc (Nutley, NJ)
- …plan. Provide strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for ... Functions Medical Affairs Strategic Plans: Under the direction of the Senior Medical Director , work with key stakeholders, management , and functional area leads… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immunology, or complex disease required- 7+ years working knowledge of Clinical trial data systems and/or EDC lab management tools is a plus preferred ... and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Applies GCP principles to ensure all external data … more
- Eisai, Inc (Nutley, NJ)
- … provides strategic development, planning, implementation, and oversight of Phase IV clinical trial programs within the Medical Affairs department. She/He ... and Clinical Operations. Essential Functions Work with key stakeholders, management , and functional area leads to develop strategic and aligned Medical Affairs… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …degree preferred A minimum of ten (10) years of progressively responsible clinical trial experience within a pharmaceutical, biotechnology, or CRO required, ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at...Director or above within CMR Training & Knowledge Management . Collaborates with global and CMR leaders and stakeholders… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …components of a large-scale global clinical program using strong clinical project and program management , leadership, decision-making ability, people ... of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , Clinical … more
- Eisai, Inc (Nutley, NJ)
- …to meet project deliverables and timelines within GV&A projects related to both clinical trial setting and observational studies.Serve as the lead statistician ... and appropriate collection, organization, and analysis of diverse data sources (eg, clinical trial data, patient registries, and observational studies) to… more
- Merck & Co. (Rahway, NJ)
- …in meetings with investigators and regulatory agencies in discussions about clinical trial issues and submission strategies.Ensures the statistical designs ... Involved in research activities for innovative statistical methods and applications in clinical trial development. Education and Minimum Requirement: PhD or… more
- Novo Nordisk Inc. (Chicago, IL)
- …in a timely fashion. In addition, the SD serves as a key member of the Clinical Trial Strategy Team, provides additional analytic support to the field team, and ... ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to...training initiatives for the medical affairs team Serve on Clinical Trial Strategy Team to identify investigators/sites… more
- Merck & Co. (North Wales, PA)
- …and retention efforts to achieve study milestonesUpon request from Global Clinical Trial Operations (GCTO),Recommends study sites and identifies potential ... Job DescriptionRole Summary: The Oncology Regional Medical Scientific Director (RMSD) is a credentialed (ie, PhD, PharmD, DNP, MD) therapeutic and disease expert who… more
- Tris Pharma (Monmouth Junction, NJ)
- …evaluation reports, etc.) Oversees reconciliation of safety data in pharmacovigilance and clinical trial databases Ensures audit and inspection readiness of Drug ... opening in our Monmouth Junction, NJ facility for a Director , Drug Safety. The Director , Drug Safety...Study Reports (CSRs), etc.); Provides expert safety guidance to clinical trial project teams and/or external partners… more
- Merck & Co. (Rahway, NJ)
- …biopharma research, such as public Omics databases (eg, GenBank, GEO), clinical trial repositories (eg, ClinicalTrials.gov), patient-level data platforms (eg, ... Sciences (RaDS) value team in Our Company's R&D IT brings together product management , engineering, and data science expertise to enable data and technology products… more
- Merck & Co. (Rahway, NJ)
- …leadership. Contribute to the business development strategy within biomarker discovery, clinical trial needs and Companion Diagnostic/Diagnostic programs in ... Job Description Position Description: Director , Business Development - Enabling Technologies Search and...conjunction with functional and clinical development leadership. Responsible for… more
- Merck & Co. (Rahway, NJ)
- …translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial simulation, disease progression models, quantitative ... and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications… more
