- 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
- Merck & Co. (North Wales, PA)
- …/scientific execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on a clinical trial team.Leading medical ... and presentation skillsEducation/Experience: Bachelor's Degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical field… 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
- 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)
- … clinical regulatory writing portfolio. With minimal oversight, the Senior Medical Writer:Demonstrates independence in preparing clinical regulatory documents ... Job DescriptionThe Senior Medical Writer is responsible for developing medical...cross-functional teams while demonstrating an understanding of team and project leadership responsibilities.Applies knowledge of clinical development,… 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
- 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)
- …design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible For:Evaluating pre- clinical ... and the further study of marketed compounds. In executing these duties, theThe Senior Director may:Supervise the activities of Clinical Scientists in the… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Global Team Leader , is a senior , cross-functional leader in Daiichi Sankyo's ... development is the cross functional, empowered and agile Global Project Team (GPT), directly accountable to global Development governance....In this key role, the candidate will have to lead a complex, global team in charge of a… 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)
- …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 both manufacturing and research divisions to assume the following responsibilities:The leader will advance the purpose and aspiration of our Company's digital ... Committee (DCRC) Steering Committee and Executive Sponsors, Digital manufacturing CMC leader will be accountable for leading the digital technology strategy,… 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
- 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
- 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
- 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
