- Genmab (NJ)
- …indication lead for both early and late-stage programs, and/or as trial responsible statistician with responsibilities as described below. The Associate Director ... in drug development and advise of new methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication… more
- Genmab (NJ)
- …compound lead, primarily up until proof of concept, and/or as trial responsible statistician.Responsibilities:Compound/Indication LevelAct as lead and main point of ... in drug development and advise of new methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …minimal direction from group head and provide statistical scientific leadership for clinical trial safety data. Lead the statistical support for safety signal ... unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in… more
- Merck & Co. (Rahway, NJ)
- …ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.The Senior Director ... marketed Neuroscience drugs;Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug… more
- Genmab (NJ)
- …with cross-functional teamsIn collaboration with medical and clinical operations teams, support Genmab-sponsored trials through trial site recommendations and ... for developing and enhancing professional relationships with medical thought leaders to support both Genmab approved products and those in various phases of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in ... diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic tests and other devices… more
- Merck & Co. (North Wales, PA)
- …in drug development.Demonstrated ability to understand and manage, with appropriate support , the resources, time, and budgets for assigned projects; is ... Clinical Investigations, Clinical Judgment, Clinical Reporting, Clinical Research, Clinical Trial Documentation, Clinical Trial Planning, Consultative Approach,… more
- Genmab (NJ)
- …team, you will drive the development of high-quality clinical documents to support operational, medical, and regulatory activities across the Genmab portfolio. You ... stakeholders. You will also be involved in developing processes and tools to support further development of the department.The ideal candidate is a strategic thinker… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Legal Operations, Innovation & Technology team's responsibilities include financial management, program law firm management, legal records and ... information management, legal technology strategy, learning and development initiatives, and increasing overall operational effectiveness.We are seeking a dynamic… more
- Formation Bio (New York, NY)
- …patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug ... the following links: Our Vision for AI in Pharma Our Current Drug Portfolio Our Technology & Platform At Formation Bio, our values are the driving force behind our… more
- Merck & Co. (San Francisco, CA)
- …leads, and finance partners, helps manage use case budgets and forecasts. Support roll up reporting and preparing for budget cycles.Resource Management: in ... knowledge management playbooks, and project management tools and dashboards to support deployment of digital solutions across the network. Incorporate relevant… more
- Merck & Co. (Rahway, NJ)
- …seeking an experienced leader who will manage a team of scientists to support drug substance process development activities to enable and accelerate early and ... (BPR&D) organization is responsible for designing and implementing novel bioprocess technology platforms and processes for upstream and downstream processes that… more
- Genmab (NJ)
- …would love to have you join us!Responsibilities:Lead programmer for a trial (s)Review CRFs for adequacy and consistencySupport establishment and maintenance of Genmab ... leaveSupport Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being supportAdditional Perks:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in ... as appropriate for the area of GxP audits assigned. Support conduct of document audits including eTMF, Clinical Study...Study Report (CSR) and Nonclinical Study Report (NCR), electronic Trial Master File (eTMF) and other pivotal documents to… more
- Genmab (NJ)
- …(tables, listings, and figures)(Preferred) Practical knowledge and experience using R to support clinical trial analyses.For US based candidates, the proposed ... of at least one study are in scope.The Programming Manager will support the Data Management, Statistics, Drug Safety, Medical, Clinical Pharmacology and Biomarker… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in ... and partnership with other functions and stakeholders in supporting clinical trial monitoring and execution through RBQM activities. Accountable for the management,… more
- Legend Biotech USA, Inc. (Baton Rouge, LA)
- …we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell ... within the assigned geographical territory through high level scientific support for research activities, publications, education, consulting, and other Medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in ... technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements &… more
- Formation Bio (New York, NY)
- …programs. Responsibilities Leadership and Strategy: Develop and implement scalable clinical trial management strategies with a technology first, additional ... Trial Management: Strategically build and implement in house clinical trial capabilities that are scalable, technology first, incorporate elements of… more
- Krystal Biotech (Pittsburgh, PA)
- …these values. Job Description Summary: Krystal Biotech, Inc. is seeking a Clinical Trial Associate to support our Clinical Operations Team. The Associate's ... sites in a timely manner, and working with the Clinical Operations team to support multiple Clinical Trials. Conducting reviews of trial data and follow GCP/ICH… more
