- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and updates Study Supply Plans in close communication with CSO project Management Lead .Responsible for the Clinical Label Development process which includes ... 7 or More Years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development . preferredOncology experience… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and ... lead the development and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of the other sections in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …& Leadership:Has primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan ... and quality metrics and share with study team, Operations Program Lead , and Sr. Director for the...Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO, 3rd… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharm patient studies, and Phases 1-3 clinical trials at the study and program level. Responsible for clinical program planning and execution (from study ... and leads the successful execution of all operational components of a large-scale global clinical program using strong clinical project and program … 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)
- …function by collaborating with internal and external stakeholders to oversee the development and delivery of clinical data programming, reporting, data ... validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Sub-team and to drive the development and delivery of the clinical development plan in alignment with the product development strategy.Manages ... with the Global Team leader as the Project Management lead on drug development projects. This position... and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …cross-functional Medical Safety collaborations within and across line functions, eg Clinical Development , Medical Affairs, Regulatory Affairs, Clinical ... external stakeholders on important drug safety issues supporting Global Medical Safety Lead . Responsible for safety governance/oversight of Clinical Safety and… more
- Bristol Myers Squibb (Madison, NJ)
- …Scientist Head as needed + Partners with the Clinical Development Lead accountable for the assigned program ; supports activities required to develop ... in their personal lives. Read more: careers.bms.com/working-with-us . The Clinical Scientist Program Lead reports...clinical development and lifecycle management plans **Position Responsibilities** + Leads… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …close communication with CSO project Management Lead . + Responsible for the Clinical Label Development process which includes creation of master label text, ... + 7 or More Years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development . preferred + Oncology… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …(s) for Clinical Data Management (CDM). + Maintains an overview of clinical program (s) status and issues and proactively communicates progress, risks, issues ... The Program Data Management Lead is responsible for...if can:** + Acts as point of contact for clinical program and study level escalation. + Reviews… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … Development Expertise Strategy:** + In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of the ... approved Safety Management Team (SMT) materials + Supports overall program safety reporting (eg, Periodic Safety Update Reports (PSURs),...and updates of the Investigator's Brochure (IB): author the clinical section and lead the development… more
- Sanofi Group (Bridgewater, NJ)
- **Global Clinical Development Strategy Expert - Vaccine** **Location: Waltham, MA** **Work model: Hybrid** **About the Job** We are an innovative global ... on millions of patients around the world. The Director Clinical Development is the clinical /medical/scientific...meetings, communications, CTD submissions) **About you** + You will lead the clinical study team and as… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Has primary accountability for operational study level time, cost and quality deliverables. + Lead the development of the clinical study plan including ... and quality metrics and share with study team, Operations Program Lead , and Sr. Director for the...Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. **CRO, 3rd… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- … studies and ensures scientific integrity and interpretation of study data of a clinical development program . The Associate Director leads in a matrix ... are seeking an Associate Director to join out Oncology Clinical Development department. The Associate Director ...day may include the following: + May function as lead Clinical Scientist for program ,… more
- Bristol Myers Squibb (Madison, NJ)
- …training Clinical Development Expertise & Strategy + In collaboration with the Clinical Development Lead , designs and develops clinical plans and ... The Senior Clinical Trial Physician sits within Clinical Development , which is a global organization...Competency Requirements** + Ability to communicate information clearly and lead presentations in scientific and clinical settings… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …pharm patient studies, and Phases 1-3 clinical trials at the study and program level. Responsible for clinical program planning and execution (from study ... execution of all operational components of a large-scale global clinical program using strong clinical ...**Responsibilities:** **Operational Strategy:** + Align with the Head of Clinical Development Operations or Senior Director, … more
- Sanofi Group (Bridgewater, NJ)
- …quality and regulatory liaisons. + Execute development programs in collaboration with program leaders that align with the overall clinical plan of specific ... **Job Title:** Lead , Sr. Director - In-Vitro Diagnostics Development...portfolio. The role will closely work with GDPU leadership, program leaders, global quality, regulatory as well as R&D… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …New Jersey_** **POSITION OVERVIEW:** With considerable independence, you will typically lead clinical pharmacology studies of increasing complexity in Virology ... and reporting, and support of regulatory filings. You will typically lead clinical pharmacology cross-functional study sub-teams, which entails coordinating… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …with cross-functional project / program teams in drug research or development . + Experience supporting clinical pharmacology study design and data analysis ... **Job Description** **POSITION OVERVIEW:** With increasing independence, you will typically lead clinical pharmacology studies of moderate complexity in… more
