- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilitiesSummaryThe Associate Director , Global Oncology Clinical Development (GOCD) ... Aid in identifying and raising opportunities for improvement initiatives, fit-for-use clinical development activities, and innovations in addition to amending… more
- 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
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director of Clinical Development Strategic Initiatives will work ... Development Officer and the Leadership Team of the Global Clinical Development Organization to provide critical support on continuing to build an… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(short-term, mid-term, long-term)These will include but not limited to Group Heads in Clinical Development , Asset & Portfolio Management, Global Clinical ... and aligned guidance to asset teams to enable seamless tumor-specific clinical development and strategyResponsibilities - Accountable for developing the… 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
- 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)
- …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
- 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 (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewTheDirector, Clinical Development will play an important role in working with ... the team to execute the global clinical development plans of brensocatib for the HSindication. Tasks include preparing clinical documents (eg protocol, study… 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)
- …of this position is to oversee bioanalysis strategy from global development and global regulatory perspectives, set standards (industry best practices), ensures ... head of regulated bioanalysis will also form strategic internal (DMPRL, Clinical Operations, Data Management, Scientific Operations etc) and external partnerships to… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections of key ... Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team Leader… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Associate Director will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from FIH to post registration. ... Responsibilities include the development of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams to execute Clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary Oversees early-stage trials, such as global clinical development program for multiple product candidates with one or ... interactions with senior management of CRO, as needed; Accountable for clinical development plans, protocol profiles and sections of key submission documents;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …aspects of Clinical Pharmacology and Biopharmaceutics studies and model-based drug development plans, serves as QCP subteam leader / clinical pharmacology ... The primary responsibilities of this position are to create the model-based drug development plan, design, conduct, and interpret Phase 1 (specifically Clinical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …that support the clinical development and regulatory requirements of a clinical program. The Director will provide high level strategic input into ... NJ. We support programs from early research through late-stage clinical development . We are building for the...development plans, study designs, and regulatory submissions. The Director will provide direction and mentoring to other members… more
