- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team Leader (ITL-ISTL)ResponsibilitiesStudy Strategy: ... regulatory agency meetings, if applicable; Defines study strategy across clinical trials within an indication or project ;...Program related: Integrated Study Team (IST) representative or IST leader on study team; Responsible before senior … more
- Merck & Co. (Rahway, NJ)
- …design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible ForEvaluating pre- clinical ... in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; andAssist the Senior /Executive Director in… more
- Aequor (Thousand Oaks, CA)
- …for candidates who are the stronger the better, can be a hands off leader , candidates who have familiarity with Pharma; Clinical Trials. Qualities an ideal ... the top end of the experience level. Ideally candidates who have strong project management experience as well as product development experience (Have skills such as… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management ... trial level. Primary activities include, but are not limited to: All responsibilities of a Senior Clinical Data Manager (SCDM) and a Clinical Data Manager… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …product development plan. This position is accountable for partnering with the Global Team leader as the Project Management lead on drug development ... supporting divisional and departmental level objectives and may also lead a non- project initiative in support of...execution of the integrated product development plan.Partners with the Clinical Team Leader to ensure a high… more
- Merck & Co. (North Wales, PA)
- …writing, able to convert complex ideas and information into simple readable form.A project leader ; completes tasks independently at a project level; ... external stakeholders including Statistical Programming, Statistics, Regulatory, Data Management, Clinical and other project stakeholders.-Primary ResponsibilitiesSupporting … more
- Merck & Co. (Rahway, NJ)
- …benefit of patients and global human health. Responsibilities :Serves as a statistical lead in project teams. Lead , develops, coordinates, and provides ... biostatistical support for related drug/vaccine projects in Late Development Statistics. Lead the interaction with Clinical , Regulatory, Statistical Programming,… more
- Eisai, Inc (NJ)
- …you. Job Summary The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. As the Lead Medical Writer, ... the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle… more
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. Job Summary The Associate Director, Clinical Outsourcing, will oversee and lead and support activities related to the ... outsourcing of clinical services to Clinical Research Organizations (CROs)...vendor selection and management options in alignment with global strategies. Lead the process of Request for Proposal (RFP) development… more
- Merck & Co. (Rahway, NJ)
- …in a fast-paced job that provides a high degree of technical and project management responsibility. The Senior Specialist - Manufacturing Automation position ... organizational skills to multi-task.Desire and willingness to learn, contribute and lead . Project Management experience with demonstrated skills.Candidate must be… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for all aspects of clinical pharmacology and biopharmaceutics studies; clinical pharmacology project lead ; supports Phase 2/3 ... of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies, conduct hands on… more
- Eisai, Inc (Nutley, NJ)
- …communicated to and executed by internal business partners and external agenciesPotentially Lead or Co- lead cross-functional project teams involving ... matrix environment; strong ability to influenceDemonstrated ability to effectively lead cross-functional project teamsStrong written and verbal communication… more
- Insmed Incorporated (Bridgewater, NJ)
- …of 15 years of experience as a regulatory toxicologist (study director/monitor and/or project lead ) in the pharmaceutical or biotechnology industry or within a ... safety studies outsourced to contract research organizations.Provide strategic input to project teams and senior management regarding the potential impact… more
- Merck & Co. (Rahway, NJ)
- …in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; andAssist the Senior /Executive Director in ... Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionFLEx is a set of multi-modality Drug Product development and GMP clinical manufacturing assets being constructed in the Rahway, New Jersey site, to ... drug products. Operational leadership of the FLEx complex is shared across two co- leader roles, and includes operations that support end-to-end GMP clinical … more
- Merck & Co. (Rahway, NJ)
- …Organization (CRO) and external statistical consultants.This position may serve as a statistical lead in project teams.The incumbent may initially work in a ... developing and coordinating statistical activities supporting drug/vaccine projects.Interacts with Clinical , Regulatory, Statistical Programming, Data Management, and our Company's… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the ... biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL)Study Planning and Execution: Provides input on… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Biopharmaceutics studies and model-based drug development plans, serves as QCP subteam leader / clinical pharmacology project team representative, supports ... project level, and interacts with regional and global project team members, senior management, and outside...and independently performs PK-PD analyses, functions as Study Team Leader for Phase 1 Clinical Pharmacology studies,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …leads the successful execution of all operational components of a large-scale global clinical program using strong clinical project and program management, ... other research areas centered around rare diseases and immune disorders.SummarySenior clinical operational leader accountable for operational planning and… more
- Merck & Co. (North Wales, PA)
- …critical that our company receives consistent, accurate, high-quality data from clinical trials conducted worldwide. REAIM ( Risk Evaluation & Adaptive Integrated ... and central analytics and ensure exquisite oversight of our clinical trials. It is also business critical the integrity...Under the oversight of the System and Data Integration Lead (SDIL), the Associate SDIL is responsible for the… more
