- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …DS standards. The Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO, 3rd Party Vendor Management and Oversight: ... and interdependencies for assigned clinical study (-ies) utilizing Microsoft Project or equivalent. Lead the creation of the cross-functional Clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) Group Lead will be responsible for overseeing multiple ... veterans and people with disabilitiesSummaryThis position will be the Clinical Science Group Lead in late phase...trial protocols, review of clinical data and Clinical Study Reports (CSRs)/outputs throughout the project … more
- Merck & Co. (Rahway, NJ)
- …development, implementation and continuous improvement of Device Development and Device Project Leader processes, procedures, and tools.Proactively resolve ... your leadership.Remain current in relevant worldwide regulatory guidance and standards. Lead /support/oversee clinical supplies production with respect to device… more
- Dana-Farber Cancer Institute (Boston, MA)
- …management of several Phase I, II, III PI-Initiated / Multi-Center oncology trials.Assist senior manager(s) in the development of a project plan that serves ... and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and...clinical research, and 5 plus years experience with project management and experience working on clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team Leader (ITL-ISTL)ResponsibilitiesMedical ... 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
- 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
- Merck & Co. (Rahway, NJ)
- …Sciences & Clinical Supply. The ideal candidate should have strong project management skills and a demonstrated commitment to operational excellence, with an ... Job DescriptionOur Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …manage a lower complexity or regional project or be partnered with a more senior project manager in support of a larger, more complex drug development ... accountable for partnering with the Global Team and Global Clinical leader to ensure effective team operations...of more complex projects in collaboration with a more senior project manager. Establishes and maintains a… 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
- 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)
- …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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for accelerated development and approval with smaller numbers of subjects exposed, Clinical Safety and Pharmacovigilance (CSPV) must be embedded in R&D as early ... This led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to...the person filling this role will pioneer and eventually lead a new group within CSPV. He/she will spearhead… 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
- Merck & Co. (North Wales, PA)
- …analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)A project leader ; completes tasks independently at a project ... This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more… more
- Catalent (Harman, WV)
- Senior Director, Supply Chain Position Summary: The Senior Director, Supply Chain is responsible for leading the supply chain organization for Catalent Maryland. ... suites coming online.Reporting to the Vice President and General Manager, the Senior Director Supply Chain directs all facets of supply chain management including,… more
- Merck & Co. (South San Francisco, CA)
- …area's biomedical community, our research ranges from exploratory biology to early clinical development. We work on diverse modalities - small molecules, peptides, ... motivated, and curious scientist for our Modeling and Informatics group. As a Senior Scientist (R3), you will be part of a multidisciplinary team, collaborating with… 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
- Merck & Co. (Rahway, NJ)
- …performing manufacturing, packaging, labeling, analytical testing, and distribution supporting the clinical supply chain on behalf of our company. Key activities ... in strategic planning activities across the Quality Unit and participates in project planning and activities of self and team activities.Makes independent decisions… more
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