- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with internal and external stakeholders to oversee the development and delivery of clinical data programming, reporting, data visualizations, external ... to achieve business objectives. It requires extensive knowledge of clinical data programming, external data ...to manage and coach people, and the capability to lead multiple projects concurrently are crucial for this role.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as well as other BDM functions, sets the vision, direction, and strategy for Clinical Data Management globally and ensures execution of the global data ... processes/ standards, internal talents/expertise/leadership, and resource planning and management.Represents Data Management in governance bodies internally and… more
- Merck & Co. (Rahway, NJ)
- …following responsibilities: Design and implement biomarker strategies for early and late-stage clinical programs. - Lead clinical biomarker sub-teams as part ... Industry, Cardiometabolic, Clinical Judgment, Clinical Testing, Clinical Trials Analysis, Creativity, Data Analysis, Detail-Oriented, Drug Discovery… more
- Merck & Co. (Rahway, NJ)
- …Skills:Adaptability, Adaptability, Analytical Chemistry, Branding, Brand Management, Clinical Data Interpretation, Communication, Corporate Branding, ... item log and follow up as neededCreating SPD yearly schedule/calendar of governance , tech reviews, and departmental meetingsOwn/Manage SPD Planner App and SPD Power… more
- Merck & Co. (Rahway, NJ)
- …measures specified in local SOPs- - Data Centric Business System Owner Operations: Lead the regulatory data governance and standards team, which manages ... strong managerial experience, a high-level strategic understanding of regulatory data governance and master data ...Activities include but are not limited to: - - Data Centric Submissions: Lead the data… more
- Merck & Co. (Rahway, NJ)
- …practices.Demonstrated experience with privacy assessments, leading incident response efforts, data governance best practices, privacy contracting and contract ... Program Development, Compliance Reporting, Confidentiality, Customer-Focused, Cybersecurity, Cybersecurity Law, Data Governance , Data Privacy, Data… more
- Merck & Co. (Rahway, NJ)
- …and operational factors.- Conducts options analysis and provides recommendation to governance for endorsement.Represent CMC and effectively communicates across the ... governance bodies, stakeholders and teams.- Drives outcomes/decisions through influence,...through to commercial manufacturing.- Deep understanding of connectivity between clinical , CMC, and HH to successfully launch a new… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas for translational medical safety and make a meaningful impact on clinical development at the program level. Lead projects to enhance processes ... on complex issues across the DS portfolio, including both compounds in clinical development and marketed products. The successful candidate will work in… more
- Merck & Co. (Rahway, NJ)
- …uninterrupted long-term supply.Represents CMC and effectively communicates across the governance bodies, stakeholders, and team to drive outcomes/decisions through ... development through to commercial manufacturing.- Deep understanding of connectivity between clinical , CMC, and HH to successfully launch a new product. Technical… more
- Merck & Co. (Rahway, NJ)
- …continuity of supply, and commercial outcomes.The VCM Product Manager will help lead the cross-functional Supply Chain Working Group (SCWG) for pipeline products or ... or Value Chain Management Team (VCMT) for commercial productsSupport and/ or lead commercial siting selection, supply chain design, and value stream mappingAssist in… more
- Merck & Co. (Rahway, NJ)
- …Assays, Bioanalytical Assays, Biomarkers, Biopharmaceutics, Business, Cell-Based Assays, Change Management, Clinical Data , Clinical Development, Clinical ... individuals who lead multi-tumor asset teams (asset team leads). Any clinical development staff reporting to the ATL will be indirect reports.Education:M.D or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …promote a quality culture within across the product portfolio by providing governance support, quality oversight of strategic initiatives in close collaboration with ... and Specialty Medicine portfolios, in alignment with the business strategy Lead the DSG inspection management activities by ensuring continued submission, compliance… more
- Bristol Myers Squibb (Madison, NJ)
- …ensuring a franchise overall portfolio view + Provide strategic insights into the clinical development plans + Lead search and evaluation activities on business ... as required + Chair departmental Staff Meetings and represent governance meetings on an ad hoc basis + Will...and into lifecycle management Leadership and Matrix Management + Lead and develop a group of Clinical … more
- Organon & Co. (Jersey City, NJ)
- …can be 100% remote in the US + There are **2 openings** The Director, Clinical Pharmacology Lead will be responsible for contributing and/or devising the ... within the Translational Medicine and Early Development (TMED) department at Organon. The Clinical Pharmacology Lead also will be responsible for the rationale,… more
- Sanofi Group (Morristown, NJ)
- …its endorsement by governance and its execution in close collaboration with clinical operations. The clinical lead is expected to advance scientific ... **Job Title:** Clinical Lead , Brivekimig **Location** : Cambridge,...Understand and keep updated with the pre- clinical , clinical pharmacology and clinical data … more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Global Head of AI-Driven Innovations, Clinical Data and AI Processing **Location:** Cambridge, MA, Morristown, NJ **About the job** At Sanofi, we ... the power of new technologies and accelerate digital transformation, we created a new Clinical Data & AI Processing (CDAIP) department within Clinical … more
- Pfizer (New York, NY)
- …Global Development Lead (and members of the development team) to establish, lead , coordinate, and execute the early oncology clinical development plan(s) for ... studies. You will work with other functional disciplines (eg, Clinical Operations, Biostatistics/ Data Management, Clinical ...more senior study clinician. Depending on experience, you may lead the development of the clinical protocol… more
- Bristol Myers Squibb (Princeton, NJ)
- …ensuring a franchise overall portfolio view** + **Provide strategic insights into the clinical development plans** + ** Lead search and evaluation activities on ... and launch and into lifecycle management** **Leadership and Matrix Management** + ** Lead and develop a group of Clinical Development professionals (both… more
- Sanofi Group (Bridgewater, NJ)
- …Senior Clinical Research Director (Sr CRD) is noted as the **primary clinical lead for programs** . The role requires a well-organized, strategic focused, ... test and cluster feasibility, medical review and validation of clinical data , study risk assessment) + Contribute...study team, medical advisors/ Clinical Project Leaders from Clinical Study Units, and investigators + Internal Governance… more
- Bristol Myers Squibb (Princeton, NJ)
- …and validation partnering with Translational Sciences colleagues when applicable + Manages clinical biomarker data delivery and analysis and associated timelines ... the late stage TM group. The individual will be a translational team lead for neurological and neuropsychiatric indications and be responsible for setting strategy… more
