- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with ... 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. (Bernards, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy:...Planning and Execution: Provides input on major milestones of trial , clinical trial plan and… more
- Merck & Co. (Rahway, NJ)
- …to these analyses.Prepares oral and written reports to effectively communicate results of clinical trials to the project team, Company Management, regulatory ... Management, and other Company Research Laboratories Scientists in designing and analyzing clinical trials , and in coordinating the statistical activities for … more
- Merck & Co. (Rahway, NJ)
- …processes for diverse biotherapeutics, and efficiently manufacture material to supply clinical trials . We are also responsible for commercial process ... Job Description Senior Scientist, Process Cell Sciences (PCS) at Rahway,...as a technical lead and functional area representative on project teams. Position Qualifications: Education Requirement: PhD in Molecular… more
- Merck & Co. (Rahway, NJ)
- … clinical development strategies for investigational or marketed Oncology drugsPlanning clinical trials (design, operational plans, settings) based on these ... development strategiesMonitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Oncology drugs.Analyzing and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in clinical trials required.Demonstrated ability to define clear clinical trial translational strategies anchored in disease biology and drug mechanism ... Global Project Team to drive scientific decision-making both from non- clinical and clinical translational aspects, through close collaboration with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …actual product Responsible for all areas related to patient safety in clinical trials Act as member of the trial safety group for dose escalation decisions ... (phase I trials ) Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator's Brochure (IB),… more
- Merck & Co. (North Wales, PA)
- …with talented and dedicated colleagues while developing and expanding your career.The Senior Clinical Director ( Sr . Principal Scientist) has primary ... clinical development strategies for investigational or marketed Oncology drugs-Planning clinical trials (design, operational plans, settings) based on these … more
- Merck & Co. (North Wales, PA)
- …datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing ... position is a key collaborator with statistics and other project stakeholders in ensuring that project plans...at least 5 years SAS programming experience in a clinical trial environment orMS in Computer Science,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …investigators is expected. The CS Group Lead will also ensure the writing of high-quality clinical trial protocols, review of clinical data and Clinical ... Clinical Science function. He/she will be responsible for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each… more
- Merck & Co. (North Wales, PA)
- …meeting. They will provide internal scientific leadership for cross-functional areas supporting clinical trials and will interact externally with key opinion ... developments, regulatory requirements, the competitive landscape, and commercial considerationsPlanning clinical trials (design, operational plans, settings) based… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …actual product Responsible for all areas related to patient safety in clinical trials Act as member of the trial safety group for dose escalation decisions ... (phase I trials ) Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator's Brochure (IB),… more
- Merck & Co. (Rahway, NJ)
- … clinical development strategies for investigational drugs and planning clinical trials (design, operational plans, settings) based on these ... development strategiesMonitoring and managing the conduct of ongoing or new clinical trials for investigational drugsAnalyzing and summarizing the clinical… more
- Merck & Co. (North Wales, PA)
- … clinical development strategies for investigational or marketed Oncology drugs;Planning clinical trials (design, operational plans, settings) based on these ... development strategies;Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Oncology drugs;Analyzing and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing ... manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team and serves… more
- Merck & Co. (North Wales, PA)
- …statistical analysis and high-quality data to support decision making in clinical trials .Support statistical programming activities for Early Oncology ... development and safety evaluation.Collaborate with statistics and other project stakeholders in ensuring project plans are...with all of the following: SAS programming in a clinical trial environment including data steps, procedures,… more
- Merck & Co. (North Wales, PA)
- … directors responsible for clinical programs.Supervises development of clinical documents including development plans, protocols, trial related documents, ... providing input into research and business development priorities and prioritization of clinical assets.-May serve as the senior liaison for relevant… more
- Eisai, Inc (Nutley, NJ)
- …pharmacokinetic (PBPK), quantitative system pharmacology (QSP) models, clinical trial simulations, literature meta-analysis, machine-learning/deep ... is driven to use cutting edge modeling approaches to advance the clinical and translational research in Neuroscience. This individual will provide scientific… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …including evaluation and interpretations of safety and efficacy data generated in the clinical trials and translation of these findings into a benefit-risk ... biotechnology industry experience (including roles in research and development (R&D), clinical trials , regulatory affairs, or medical affairs Leadership… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ensuring that market access considerations and needs are incorporated into future clinical trials , pre-launch, and commercialization initiatives for inline and ... and MASH. Interacts frequently in collaboration with internal management and senior level managed markets customer representatives. Interacts internally with team… more
