- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & ... management for global processes across Global Regulatory Affairs and Clinical Safety . The Global Process Lead ...working a Hybrid work consisting of three total days on- site per week, Monday - Thursday, although the specific… more
- Merck & Co. (Rahway, NJ)
- …Distinguished Scientist (Executive Director) and Product Development Team (PDT) Lead , Oncology Global Clinical Development, has primary responsibility ... field of m elanoma . The Executive Director, PDT Lead will manage the entire cycle of clinical...working a Hybrid work consisting of three total days on- site per week, Monday - Thursday, although the specific… more
- Merck & Co. (North Wales, PA)
- …and may develop, specialized methodology to project program/study milestones, create site selection criteria, and establish need for patient recruitment and ... experienced GTOS by demonstrating, on-the-job, the evidence based approach to clinical trial planning. Provides training, mentorship and instructions on GTO methods… more
- Merck & Co. (North Wales, PA)
- …/scientific execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical ... the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position,...working a Hybrid work consisting of three total days on- site per week, Monday - Thursday, although the specific… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution ... input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the site...and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of… more
- Merck & Co. (Rahway, NJ)
- …including those new to the organization therefore requiring someone who has built and lead clinical development plans from the ground up. They will also be ... Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Respiratory will focus on driving strategy, development, and life-cycle… more
- Genmab (Plainsboro, NJ)
- …handling, and cold chain management.Proven experience working with CMOs for clinical trial supplies, including vendor management.Ability to lead cross-functional ... purpose.The Role & DepartmentGenmab is seeking an experienced Senior Clinical Drug Supply Manager to join our Global ...to ensure scalability.It is expected that you will take lead of strategic initiatives, mentor colleagues, and resolve complex… more
- Insmed Incorporated (San Diego, CA)
- …Medical Director of Ophthalmology, Clinical Development holds the responsibility to lead clinical programs across different diseases and supervise the ... from first-in-human trials, through to full development.Serve as the therapeutic area lead of the ophthalmology clinical development team, partnering closely… more
- Insmed Incorporated (San Diego, CA)
- … Research Scientist (CRS) will support and work predominately with the Clinical Trial/Indication Lead (s) and Medical Monitor(s) for assigned protocols and/or ... with vendors and cross functional teams. The Senior CRS will provide clinical and scientific support to clinical development and operations, regulatory,… more
- Merck & Co. (New York, NY)
- …background and a growth mindset to join our team. As the Regional Cardiovascular Lead (RCL), you will have a key role in shaping and supporting the transformation ... is a critical position where you will actively engage with scientific and clinical leaders in the cardiovascular field within your assigned geography.In this role,… more
- Merck & Co. (PA)
- …scientific background and leadership skills to join our team as the Regional Cardiovascular Lead Manager for the East District. In this role, you will lead ... including overnight travel, and for meetings at HQ.The Regional Cardiovascular Lead Manager will report to the Director of Regional Cardiovascular Team.-Primary… more
- Merck & Co. (Rahway, NJ)
- …to ensure full integration of the device development activities with the clinical , regulatory, formulation, commercial and other key Ofunctions. Lead the Device ... IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership. Lead /support/oversee clinical supplies production with respect to device… more
- Merck & Co. (South San Francisco, CA)
- …as mechanistic experimentation to advance drug discovery from target concept through lead optimization. The candidate will also work closely with therapeutic area ... immuno-metabolic, and cardiovascular diseases to enable a robust drug discovery pipelineDrive hit/ lead finding and lead optimization plans in collaboration with… more
- Aequor (Waltham, MA)
- …drug substance (DS), drug product (DP) and analytical development, DS/DP clinical manufacturing, and support of global regulatory filings from IND submission ... to interact with all levels and functions at the 225 Waltham site . They would display creative problem-solving techniques to accommodate a dynamic environment.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the Quality team based in Raritan, NJ. Role OverviewThe QA Document Control Lead role is an exempt level position with responsibilities for supporting the document ... management process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will… more
- Merck & Co. (South San Francisco, CA)
- …of early clinical strategy for novel therapeutics including authoring initial clinical and biomarker plans for Lead Optimization programs, early clinical ... Medicine at our Research Division is responsible for early clinical development of novel therapeutics, working in close collaboration...working a Hybrid work consisting of three total days on- site per week, Monday - Thursday, although the specific… more
- Merck & Co. (Rahway, NJ)
- …Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team that will build biopharmaceutics ... stakeholders across organizations such as Regulatory CMC, formulation functions, and clinical functions to ensure timebound progression of portfolio, initiatives for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …following CRA central oversight activities: Determine CROs compliance with monitoring plan for on- site and remote site visits (expectations of staff contact, ISF ... review, IP review, SDV/SDR, etc.)Establish and lead the Sponsor Oversight Visit process. Provide oversight of the DS Trip Report Review process.Responsible for… more
- Genmab (NJ)
- …other cross-functions to provide high-quality and timely deliverablesResponsibilities Lead or co- lead one or more complex clinical trial(s) in a therapeutic ... global development strategy leading or co-leading one or more clinical trials in a therapeutic area for one or...other key data management deliverables (eg database lock activities). Lead the development of medical data review plan (MDRP),… more
- Merck & Co. (Rahway, NJ)
- …programming requests in close collaboration with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data, transform the data into ... and colleagues in other related function areas. Primary Activities : Lead programming deliverables for multiple studiesProvide technical consultation and analytical… more
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