- Merck & Co. (Rahway, NJ)
- …timely completion of carefully designed clinical trials is critical to drug development .The Associate Director , Clinical Trials Communications role ... enterprise-wide clinical trials communications strategy which includes the following:Amplify clinical trial key messages by managing the development of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing ... & Simulation plans from FIH to post registration. Responsibilities include the development of Clinical Pharmacology and Modeling and Simulation plans, design… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director Immuno-Oncology as part of the Research and Development ... of developing innovative cell-based therapies. We are seeking an experienced and dynamic Associate Director to lead our in vivo CAR-T cell therapy program.… more
- Merck & Co. (Rahway, NJ)
- …financial support to Global Clinical Supply (GCS) and Global Clinical Development (GCD) for Drug Supply (both externally-purchased comparators and ... but not limited to the Global Clinical Supply team and the Global Clinical Development Finance team to ensure coordinated planning and execution of client… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(CDx) in support of projects within Daiichi Sankyo's Early and Late Stage Development Portfolio. The individual will play a key role in making Precision Medicine ... Teams (GPT) for the therapeutic, covering all areas from CDx assay development through CDx approval and launchLeads CDx Partner evaluation and selection activities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …industry, vendor base, and regulatory issues for respective categories. Leads the development of sourcing strategy for respective categories. Builds and maintains a ... vendor base. Manages vendor relationships. Implement sourcing and value development roadmap and initiatives; contribute to strong supplier relationship management,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction ... of the Senior Director , GMA Oncology (Global Medical Affairs team lead for...a specific compound or indication. Responsibilities Support GMA the development of the Global Medical Affairs strategy and execution… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director , Quantitative Systems Pharmacology (QSP) will work within the ... therapeutic compounds. This includes working with scientists in Research, Translational Science, Clinical Development , in addition to colleagues in QCP. QSP… more
- Merck & Co. (Rahway, NJ)
- …control and risk management techniques to positively support and influence clinical and commercial combination product development and launches.Principal ... cross-functional Device Working Group to ensure full integration of the device development activities with the clinical , regulatory, formulation, commercial and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the ... diverse external providers for clinical trials, companion diagnostics trials, clinical development , and regulatory submissions. This position may propose… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Project Planning and Forecasting - Manages and is accountable for the development and control of Clinical Project Budget in support of ... I-III clinical studies. Partner with Project Management, Clinical Operations and other functional groups to ensure budgets...Budget Planning - Manages and is accountable for the development and control of functional budget in support of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … sub-team and to drive the development and delivery of the clinical development plan in alignment with the product development strategy.Manages ... Summary This position is responsible for providing project management, drug development expertise to Global Project Teams including strategic development … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, ... preparation of data for statistical analysis to obtain background rates) for development of safety documents (eg, RMP), support SMTs, SERM or other safety-related… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The CRA Oversight Associate Director plays an integral role in the strategic development ... initiatives, novel technology or techniques in the context of clinical development . requiredProven change management experience required.Proven strategic… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Value Access & Pricing will both develop ... with global functions including but not limited to Commercial, Marketing, Medical, Clinical Development , Public & Government Affairs.Responsibilities- Lead the … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …all phases of drug development , including early and late phase clinical development and submission preferred- Solid background in applied statistics ... to support submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Site-Launch activities and associated teams for internal and external sites and development projects. Serve as the main interface to internal and external ... gaps at the manufacturing sites.- Conduct scouting activities and recommend CDMOs for clinical and launch site selection from Tech Mgmt. (mAb, Drug Substance, Drug… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …veterans and people with disabilities.SummaryThis position supports early phase oncology development and leads complex studies in study design, statistical analysis ... with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …high quality deliverables on time and within budget to support drug development processes and global submissions. This position provides leadership within Data ... and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position… more
