- Eisai, Inc (Nutley, NJ)
- …they relate to efficient execution of the development plans. Advanced understanding of clinical trial management , including general understanding of all ... this is your profile, we want to hear from you. JOB SUMMARYThe Director , Clinical Project Management will manage assigned project (s), including program's… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, ... inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are… 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
- Eisai, Inc (Nutley, 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
- Merck & Co. (Rahway, NJ)
- …or related field plus at least twelve (12) years SAS programming experience in a clinical trial environment or a Master's degree (or its US equivalent) in ... or related field plus at least ten (10) years SAS programming experience in a clinical trial environment.Experience must also include at least seven (7) years of… 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
- Merck & Co. (Rahway, NJ)
- …pharmacokinetics (PK) and pharmacodynamics (PD) analysis, model-based meta-analysis (MBMA), clinical trial simulations (CTS), disease progression modeling and ... modalities to drive portfolio impact from discovery through life-cycle management . The team is externally visible and continues to...seek to improve cycle time, cost/size, number of trials, clinical trial design and Go/No Go decisions-… more
- Merck & Co. (Rahway, NJ)
- …(popPK), PK/PD models, exposure response (ER) models, model-based meta-analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into ... modalities to drive portfolio impact from discovery through life-cycle management . The team is externally visible and continues to...seek to improve cycle time, cost/size, number of trials, clinical trial design and Go/No Go decisionsFraming… 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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …investigators is expectedThe CS Group Lead will also ensure the writing of high-quality clinical trial protocols, review of clinical data and Clinical ... Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical ...will include but not limited to Group Heads in Clinical Development, Asset & Portfolio Management , Global… more
- Merck & Co. (Rahway, NJ)
- …stakeholders including the Global Project Manager, Alliance Manager, Global Trial Manager, Clinical Sub Team, Clinical Trial Team, Outsourced Trial ... and improve lives. -Position Description: Under the guidance of the Oncology Clinical Development Finance Associate Director , the Finance Senior Specialist… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Provides medical input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the site feasibility ... research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, ... inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …2 Studies: Provides input on major milestones of trial , clinical trial plan and contingency planning, Analyzes, updates management on potential risks to ... and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …deliver a proactive safety strategy for such candidates by the start of the FIH trial (DP1).- Clinical Development and Post Marketing: Consult with PSLs/GPTs on ... for accelerated development and approval with smaller numbers of subjects exposed, Clinical Safety and Pharmacovigilance (CSPV) must be embedded in R&D as early… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Data Management expertise to promote best practices across the Clinical Trial lifecycle.Qualifications: Successful candidates will be able to meet ... immune disorders. Summary Position manages the end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other… more
