- Novo Nordisk Inc. (Plainsboro, NJ)
- …MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development . We are building for the future, creating a distinct ... About the Department Our East Coast Global Development Hub brings together the best minds in...functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions Serve… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Seattle reflect the full R&D continuum, from early research through late-stage clinical development . Here, we are building for the future, creating a ... internal and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key internal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for operational improvements and seek agreement through consensus management.RelationshipsReports to an Associate Director / Director within the NNI ... hard work and dedication with opportunities for continuous learning and personal development . Are you ready to maximize your potential with us? The PositionThis… more
- Tris Pharma (Monmouth Junction, NJ)
- …have an immediate opening in our Monmouth Junction, NJ facility for an Associate Director , Alliance Management.Tris Pharma has a long track record of ... spanning many departments across all stages of the product lifecycle. The Associate Director , Alliance Management will be accountable for managing alliances… more
- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary: The Associate Director of Regulatory Writing is a key role responsible for ... and provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of ... Global Medical Affairs' externally sponsored clinical research (ESR) initiatives, ensuring strict adherence to Good Clinical Practices (GCPs), relevant Standard… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the US, EU, Japan, and other global sites. These business functions include: Clinical Operations, Clinical Development , Biostatistics and Data Management, ... areas centered around rare diseases and immune disorders.Job Summary Deliver the development and implementation of informatics systems and programs to support the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …leads statistical support for medium complexity studies including contributing to development of optimal study design, independently develop and execute statistical ... 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. (Bernards, NJ)
- …with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to ... under some supervision to solve complex study problems. Responsibilities Protocol Development , Case Report Form (CRF; review), Statistical Analysis Plan (SAP),… more
- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, NJ)
- …technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements ... laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …increased complexity including post marketing projects and those involving 3rd party development . This position partners with GRLs and Clinical Safety ... may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU....may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.Ensure… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …robust publication plans for the Therapeutic Area and respective products. Mentor Associate Director Publication leads on publication planning and execution ... workManage Publication tracking and announcement, in coordination with Medical Director and Medical Information /Education functionContribute to development … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Manager role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This ... operational study level time, cost and quality deliverables.Lead the development of the clinical study plan including...share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis and ensure… more
- AbbVie (Branchburg, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director , Clinical Development will have global ... Lead and Clinical Science Lead and Clinical Scientist. The Associate Director , Clinical Development should expect to be asked to participate… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- … Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the development , evaluation, ... scientific integrity and interpretation of study data of a clinical development program. The Associate Director leads in a matrix environment as part of… more
- CenterWell (Trenton, NJ)
- …the ambassador for value-based, senior care model in the primary care network. The Associate Director , Clinical Coding Education (RN) will develop, design, ... in addition to managing a team of role-based trainers and training facilitators. The Associate Director , Clinical Coding Education (RN) role will report to… more
