- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director, Clinical Operations may act as the Study Team ... disorders. Job Summary: The incumbent will be responsible for ensuring execution of clinical studies across geographic regions, in adherence to Good Clinical … more
- Genmab (NJ)
- …the portfolio. The employee will also provide input to Genmab clinical drug development programs to ensure data management ... and timely delivery of complete, high quality and reliable clinical trial data. The Associate Director DM...within all phases of clinical trials.Experience with clinical trials and the drug development processSignificant… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Respiratory will focus on driving strategy, development, and ... those new to the organization therefore requiring someone who has built and lead clinical development plans from the ground up. They will also be responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical industry experience in one or more of the following areas: Drug Safety, Epidemiology, and Clinical Development preferredDaiichi Sankyo, Inc. is ... rare diseases and immune disorders. Summary This position works with the Director, Clinical Study Startup to establish the strategy driving global Clinical Study… more
- Merck & Co. (Rahway, NJ)
- …degree (eg, MS, MBA, Ph.D., PharmD) preferred - Experience and knowledge of clinical drug development strongly preferred; including the different phases of ... Job Description Job Description: - The drug development Project Manager is part of Global...of our company. - Position Description/Summary: - The GPAM Associate Director, Project Manager, is a core member of… more
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Clinical Trial Manager (GCTM) is accountable for the end-to-end delivery of a ... single or multiple clinical trials from strategy outline through to CSR by...CPL in a timely mannerExecute operational strategies related to drug supply, regulatory submissions, and recruitmentBudget and PlanningAssist in… more
- Merck & Co. (Rahway, NJ)
- …clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications.-Developing ... to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publications.Participation in internal and… more
- Merck & Co. (Rahway, NJ)
- …clinical and translational work for the purpose of generating the early clinical development plan and Investigational New Drug applications. Providing ... studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication Participation in internal and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … development (eg, nonclinical, pharmacokinetics, biostatistics).ResponsibilitiesWrite critical, complex clinical and clinical pharmacology documents (eg, pivotal ... other research areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for producing… more
- Merck & Co. (Rahway, NJ)
- …on drug /vaccine development programs, and author or co-author strategic documents. Associate Directors are expected to have or be developing expertise in several ... clinical trial design and Go/No Go decisionsFraming critical drug development questions for optimizing model-informed development-Responsible for developing and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good ... Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on… more
- Genmab (NJ)
- …implementation of the global development strategy leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds in various ... stages of clinical development (including clinical trial implementation, and...research with at least 4 or more years of drug development experience Prior oncology/hematology drug development… more
- Genmab (NJ)
- …as trial responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and ... be our best, and authentic is essential to fulfilling our purpose.The RoleThe Associate Director acts as a statistical expert supporting the clinical development… more
- Aequor (South San Francisco, CA)
- …to support the overall safety assessment for our Client therapeutics spanning drug discovery through clinical development and marketing. The group provides ... Job Title : Research Associate II Location : South San Francisco, CA...toxicities that are observed non-clinically and / or in clinical trials through hypothesis driven research. This process involves… more
- Merck & Co. (Boston, MA)
- … Associate Principal Scientist to contribute to our small molecule and peptide drug discovery and early clinical development efforts. -This position will be ... labs in Boston, MA.- The ideal candidate will lead drug metabolism and pharmacokinetic (DMPK) efforts as a project-team...and in vivo studies to understand the impact of drug disposition on disease biology, pharmacological response (PK/PD) and… more
- Merck & Co. (North Wales, PA)
- …supports statistical programming activities for multiple and/or late stage drug /vaccine clinical development projects. -Accountability predominantly includes the ... tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The… more
- Merck & Co. (Rahway, NJ)
- …& Process Development (DPPD) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe and ... and risk management techniques to positively support and influence clinical and commercial combination product development and launches.Principal ResponsibilitiesLead… more
- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.The Role & DepartmentThe Associate Director, Vendor Management, will play a pivotal role in managing the ... relationships with the clinical vendors as well as coordinate and manage outsourcing...next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody- drug conjugates. To help develop and deliver novel antibody… more
- Merck & Co. (Rahway, NJ)
- …within our company's Research Laboratories is responsible for developing the drug substance manufacturing processes for our company's biologics pipeline. We work ... closely with colleagues in Discovery, Pre- clinical and Early Development to rapidly develop manufacturing processes...our Downstream Process Development and Engineering group as an Associate Principal Scientist.- In this role, you will work… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies… more
