- Tris Pharma (Monmouth Junction, NJ)
- …NJ facility for an experienced MD to serve as Senior Director or Director , Clinical Development . Title and salary commensurate with experience. The ... position is a core member of the Clinical Development management team responsible for developing and implementing, in alignment with corporate strategy, the … more
- Catalent (MA)
- Job DescriptionAccount Director , Clinical Development & Supply With ten facilities in the US, EU, and Asia/Pacific region, and more than 50 depots covering 6 ... your drug to market.This position is for an Account Director position within the company, We are looking for...of all sizes to advance new medicines from early development to clinical trials and to the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. SummaryThe Associate Director , Global Oncology Clinical Development (GOCD) Functional ... Aid in identifying and raising opportunities for improvement initiatives, fit-for-use clinical development activities, and innovations in addition to amending… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …mid-term, long-term). These will include but not limited to Group Heads in Clinical Development , Asset & Portfolio Management, Global Clinical Operations, ... and aligned guidance to asset teams to enable seamless tumor-specific clinical development and strategy. Responsibilities - Accountable for developing… more
- Merck & Co. (Rahway, NJ)
- …research activities involving investigational compounds in Immunology. With a focus on late-stage development , the Senior Clinical Director will manage the ... the development of new compounds The Senior Clinical Director may: Oversee the Clinical...area of responsibility. To accomplish these goals, the Senior Clinical Director may: Author detailed development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , ... research areas centered around rare diseases and immune disorders.SummarySenior clinical operational leader accountable for operational planning and execution of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the development , maintenance, and ... pipeline.Proactively identify Data Standards gaps and resolve issues related to clinical data standards development throughout the trial lifecycle.Standardize… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development , an organization dedicated to the effective strategy, design, ... medical guidance for coding of AEs, medical history, and medications when needed- Clinical Development Expertise Strategy- In collaboration with the Global … more
- Merck & Co. (North Wales, PA)
- …of clinical data/medical protocol-deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct/indirect team members ... years OR Master's + 6 years OR PhD/PharmD + 2 years Pharmaceutical and/or- clinical drug development experience. Degree in life sciences, preferred.NOTICE FOR… more
- Merck & Co. (Rahway, NJ)
- …Working with the Asset Development Team (ADT's), early- & late-stage clinical development teams, the Biomarker (BMx) leads will develop asset-specific ... biomarker strategy by incorporating critical insight from discovery biology, clinical development , diagnostics, bioinformatics, molecular assay experts,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a key member of the Global Product Team in collaboration with Clinical Development , Regulatory, Project Management, Biostatistics, Pharmacology, and other ... well as other research areas centered around rare diseases and immune disorders.Summary The Director , Clinical Safety, will be a product safety lead or part of… more
- Merck & Co. (North Wales, PA)
- …is business savvy and results-oriented. Expert knowledge and understanding of Clinical Development processes and procedures. Master project management and ... Job DescriptionPosition Description: Director , Global Clinical Trial Operations (GCTO)...Proven ability to analyze, integrate, recommend, contribute to the development of conceptual plans for, and lead the implementation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Director , Global Clinical Operations (GCO) Clinical Trial Operational ... a comprehensive interface for risk and issue management with strategic development partners.Close partnership with clinical quality management and other… more
- Merck & Co. (North Wales, PA)
- …Advanced degree (eg, MS, MBA, Ph.D., PharmD) preferredExperience and knowledge of clinical drug development strongly preferred; including the different phases of ... Job DescriptionThe drug development Project Manager is part of Global Project...organization of our company.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core member of Early… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …by external partners such as CROs. Exceptions must be discussed with clinical development .Review, approve and/or drive related process related improvement to ... and Infrastructure.Build processes withing GCO to achieve diversity in clinical trials and patient focused drug development ...in clinical trials and patient focused drug development (ie. Patient voice) that are effective, streamlined and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, ... and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in end-to-end clinical trial execution in one or more key functions (eg clinical research & development , clinical science, clinical quality ... areas centered around rare diseases and immune disorders. Summary The AD, Global Clinical Operations (GCO) Clinical Trial Operational Risk (CTOR), will be… more
- Insmed Incorporated (San Diego, CA)
- …for the development of, and the oversight for execution of clinical studies milestones to support company budgets, and quality standards.Ensure the clinical ... lists.OverviewThe primary responsibilities are to manage all aspects of clinical operations including study planning, financial oversight, project deadlines and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an advanced degree required.6-9 years of experience with a bachelor's degree required. Clinical development or post-marketing experience to be able to apprehend ... (SAPs) and statistical outputs (tables, figures, and listings [TFLs]), and other clinical study documentsAuthors or oversees the development of safety sections… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …accountability for operational study-level timeline, cost, and quality deliverables.Lead the development of the clinical study plan including critical path ... trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study Team Leader for… more
