- 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 ...and Clinical Safety . The Global Process Lead actively engages with leadership across the Global Regulatory… 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 ... development and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of the other sections in collaboration with the… 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
- Insmed Incorporated (San Diego, CA)
- …Medical Director of Ophthalmology, Clinical Development holds the responsibility to lead clinical programs across different diseases and supervise the ... trials, through to full development.Serve as the therapeutic area lead of the ophthalmology clinical development team,...the therapeutic area lead of the ophthalmology clinical development team, partnering closely with heads of … more
- Merck & Co. (Rahway, NJ)
- … Clinical Supply Planning organization to customers both internal and external to Global Clinical Supply and serves as the lead Global Clinical Supply ... but are not limited to:--Interacts closely with key partner organizations (as a lead Global Clinical Supply Planning program representative) such as clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …leaders, advisory boards, industry councils and the broader medical community. Essential Functions Lead the clinical informatics team in the (CDSE) department of ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...you ready to make a difference? The Position Senior, Clinical Informatics leads the functions in the Clinical… more
- Merck & Co. (Rahway, NJ)
- …Distinguished Scientist (Executive Director) and Product Development Team (PDT) lead , Oncology Global Clinical Development, has primary responsibility ... the field of breast cancer. The Executive Director, PDT lead will manage the entire cycle of clinical... lead will manage the entire cycle of clinical development, including development strategy, study design, initiation, execution,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Product Evolution Oversee product strategy and regulatory activities related to new clinical data or label changes. Lead modification to marketing strategies ... embark on shaping our future. The Position The Rare Bleeding Therapeutic Area Lead is instrumental in shaping and executing NNI's strategic direction and initiatives… more
- Merck & Co. (Rahway, NJ)
- …to drive data excellence and enhance the efficiency of our clinical research operations.Key Responsibilities:- Lead Data Management Initiatives:-Direct the ... qualified and experienced Associate Director in Data Management to lead our data management team in supporting the pharm...management team in supporting the pharm and vaccine veterinary clinical trials. The ideal candidate will be responsible for… more
- Genmab (Plainsboro, NJ)
- …will represent CPQS in the Translational and Quantitative Sciences Leadership Team and lead strategic development of pre- clinical and clinical pharmacology ... requires being onsite 60% of the time in Princeton, NJResponsibilitiesBuild, oversee and lead delivery of pre- clinical and clinical pharmacology team across… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams on various clinical projects and may function as the Lead Clinical Data Programmer on multiple projects simultaneously. ResponsibilitiesPerform all ... to support drug development processes and global submissions as required for clinical trials. These include developing and validating SAS programs for clinical… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization, within our Research & Development (R&D) Division , is accountable for managing the 'end-to-end' ... integrated clinical supply chain across all of the R&D portfolio...and imaginative strategiesProven success in developing diverse talentAbility to lead , create future state, and deliver resultsResults-orientated with the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization, within our Research & Development (R&D) Division , is accountable for managing the 'end-to-end' ... integrated clinical supply chain across all of the R&D portfolio...and imaginative strategiesProven success in developing diverse talentAbility to lead , create future state, and deliver resultsResults-orientated with the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. Summary Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical ... Monitor. Represents Clinical Development on Study Team and collaborates as team...quality assessment of Tables/Listings/Graphs before database lock; collaborates with lead statistician on SAP update, as needed. Provides input… 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 ... Translational Medicine at our Research Division is responsible for early clinical development of novel therapeutics, working in close collaboration with Discovery… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Clinical Director (Principal Scientist) has primary responsibility for the strategic planning and directing clinical research activities ... investigational compounds in Immunology. With a focus on late-stage development, the Clinical Director will manage the entire cycle of clinical development,… more
- Genmab (Plainsboro, NJ)
- …to support efficient operations.Forecast demand, manage inventory, and prevent stockouts. Lead cross-functional collaborations, including Clinical Project Supply ... purpose.The RoleGenmab is searching for an experienced Director, Global Clinical Drug Supply to be part of Global ...Clinical Drug Supply to be part of Global Clinical Drug Supply (GCDS) Planning Team in Princeton and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … 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
