- Daiichi Sankyo, Inc. (Bernards, NJ)
- …early clinical safety for our Rare Disease/Specialty Medicine portfolio. SummaryThe Director , Clinical Safety, will be a product safety lead or part ... , and provide safety leadership including but not limited to clinical studies, post-marketing surveillance, signal detection and management , important… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in ... projects concurrently are crucial for this role. Advanced knowledge of Data Management , Biostatistics, Clinical Operations, Pharmacovigilance, handling… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as well as other research areas centered around rare diseases and immune disorders.SummaryThe Director , Clinical Safety, will be a product safety lead or part of ... , and provide safety leadership including but not limited to clinical studies, post-marketing surveillance, signal detection and management , important… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review Plan ... Director , Clinical Development Join a Legacy...Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility… more
- Merck & Co. (Rahway, NJ)
- …communicate with stakeholders at various levels, including cross-functional teams, senior management , external vendors, and clinical sites. Strong negotiation, ... Project Management Skills: strong knowledge of the principles of project management and clinical customer relationship management . - Technical… more
- Merck & Co. (Rahway, NJ)
- Job Description Product Manager , Trial and Site Management Product Line - - Job Description - - Our Company Research Labs IT team partners with the Clinical ... and passionate P roduct Manager for Trial and Site Management P roduct L ine to own the product...- Work closely with software engineers , UX designers, data engineers, quality engineers and other product teams and… more
- Formation Bio (New York, NY)
- …communication and collaboration between internal teams, such as Clinical Development, Clinical Data Management , and Site Identification, and external ... to bring new treatments to patients faster and more efficiently.About the PositionThe Director of Clinical Trial Management is responsible for leading… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …assignment and oversight of the group. This position reports to the Associate Director Data Management Operations. Business administration activities within ... rare diseases and immune disorders. Job Summary: The Manager, Clinical Data Repository Administration is a member...response & management ; knowledge of industry standard clinical technologies including, EDC, Clinical Data… more
- Merck & Co. (Rahway, NJ)
- …Dossiers for use by local subsidiaries in their local HTA submissionsDevelops supplementary clinical data package in close partnership with markets and HTA ... the guidance of a senior leader, a Senior Principal Scientist/Senior Director , has primary responsibility for developing value evidence strategies, and… more
- Merck & Co. (Rahway, NJ)
- …standards of reference data and chemical nomenclatureLeading nomenclature and reference data projects or other data management tasksFacilitating timely ... or reference/master data standards (US and/or international)Experience with master data management systems, content, and processesExperience in master … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. SummaryReporting to the Senior Director , I&A, the Associate Director , Global Oncology Forecasting will drive ... creation of demand and revenue forecasts. The Associate Director is a dynamic member of the Global Oncology...Integrate with the Global Marketing teams and provide a data driven point of view for inline and pipeline… more
- Merck & Co. (Rahway, NJ)
- …role of Associate Director QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to ... clinical pharmacology and pharmacometrics of oncology drugs from post-PCC...Data Visualization, Machine Learning, Software Development, Stakeholder Relationship Management , Waterfall ModelPreferred Skills:Job Posting End Date:03/31/2025 *A job… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …brands. Additionally, the Executive Director contributes to excellence in clinical research by developing strategies for lifecycle management , IIS programs ... Affairs activities including strategy, communications, and medical affairs directed clinical activities across the oncology portfolio. The position has leadership… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …non-compliance such as: different approaches to data review in conjunction with Data Management and Clinical Science, audit trail review for non-logical ... achieve a Quality by Design (QbD) and Risk-Based Quality Management (RBQM) approach to clinical trial conduct....CSM to improve quality and ensure patient safety and data quality and integrity.Establish, measure, analyze and report on… more
- Merck & Co. (Rahway, NJ)
- … Visualization, Machine Learning, Software Development, Stakeholder Relationship Management , Waterfall ModelPreferred Skills:Job Posting End Date:03/31/2025 *A job ... Job DescriptionAssociate Director - Pharmacometrics, Quantitative Pharmacology and PharmacometricsThe Quantitative...modalities to drive portfolio impact from discovery through life-cycle management . The team is externally visible and continues to… more
- Merck & Co. (Rahway, NJ)
- … Visualization, Machine Learning, Software Development, Stakeholder Relationship Management , Waterfall ModelPreferred Skills:Job Posting End Date:03/28/2025 *A job ... therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management . The team is externally visible and continues to be at the… more
- Merck & Co. (Rahway, NJ)
- … Visualization, Machine Learning, Software Development, Stakeholder Relationship Management , Waterfall ModelPreferred Skills:Job Posting End Date:03/31/2025 *A job ... therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management . The team is externally visible and continues to be at the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the guidance of a senior leader, a director has primary responsibility for developing value evidence strategies, and planning/managing real ... V&I goals. Responsible for study-related contracting, budgets, and vendor/partner management .Support market affiliates to develop local outcomes research plans,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core ... Data Sheets (CCDS) for assigned products. This position drives/leads...through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategizes and plans for FDA meetings as… more
