- 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
- 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
- Formation Bio (New York, NY)
- …to bring new treatments to patients faster and more efficiently.About the PositionThe Director , Quality Management Systems plays a pivotal role in ensuring ... progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately...of an effective, compliant and 'fit for purpose' quality management system (QMS) ensuring Formation Bio is in a… more
- Formation Bio (New York, NY)
- …development through regulatory submissions and approvals. Ability to collaborate cross-functionally with Clinical , Data Management , Programming, Data ... and improve trial efficiency. Regulatory & Cross-Functional Collaboration: Partner with Clinical , Data Science, Regulatory, and Business Development teams to… 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
- 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
- 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
- Formation Bio (New York, NY)
- …including specification development, manufacturing, product release, stability programs, change management , and vendor oversight. The Sr. Director ensures ... progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately...to patients faster and more efficiently.About the PositionThe Sr. Director , GMP Quality Assurance will lead the GMP QA… 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
- Formation Bio (New York, NY)
- …and continuous improvement among the Design team and its core partners (Product Management and Engineering, as well as scientific, data , and operational ... 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
- 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
- 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)
- …Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers.Develop supplementary clinical data package for submission to Health Technology Assessment ... value evidence strategies for in-line and pipeline products. Obtain senior management approval of value evidence generation plans. Provide outcomes research… more
- Merck & Co. (Rahway, NJ)
- …such as manufacturing process development and validation, design control, risk management , material and molding, design validation to create and execute design ... verification strategies that successfully supports the clinical instruction(s) and commercial market approval(s) of combination products.Principal Responsibilities… 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
- 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
- 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
