- Sun Pharmaceutical Industries, Inc. (Blawenburg, NJ)
- Director , Clinical Operations /CPM Sun Pharma Advanced Research Company, Limited Summary The Director , Clinical Operations /CPM is responsible for ... the development of a Clinical Operations Team in the United States. Work with Function...contract review. Act as primary point of contact from clinical operations for assigned trials. Oversee study… more
- Sun Pharmaceutical Industries, Inc. (Blawenburg, NJ)
- Associate Director , Clinical Operations Sun Pharma Advanced Research Company Limited Princeton, New Jersey Summary The Associate Director , Clinical ... process, and contract review. Act as primary point of contact from clinical operations for assigned trials. Oversee study start up activities of CROs (eg… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …limited to Group Heads in Clinical Development, Asset & Portfolio Management, Global Clinical Operations , BDM and DLT members. He/she will also serve as the ... in one or several programs. Partner and collaborate with RD leaders in Clinical Operations , Biostatistics and Data Management, Regulatory Affairs, and other RD… 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)
- …safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant ... medical topics, and supports PV Operations ' medical review function. This position supports a senior...board eligibility preferred Experience Qualifications1 or More Years of clinical experience preferred Daiichi Sankyo, Inc. is an equal… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …stakeholders including members of Global Companion Diagnostics, Translational Sciences, Global Clinical Operations , Biostats and Data Management and Clinical ... IVD Development Process, with direct experience with Companion Diagnostics implementation in clinical trials and companion diagnostics operations is a plusSolid… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and cross-functionally. Additionally, this position possesses advanced knowledge of clinical operations and relevant regulatory requirements. This position ... as DM SME in internal audits and/or regulatory on-site inspectionsKnowledge of clinical trial operations , clinical trial data flow, pharmacovigilance,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders.Provides support ... other research areas centered around rare diseases and immune disorders. Summary The Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execution plans across and effective alignment within (eg with translational research, clinical operations , clinical development, medical affairs CSPV and ... A cross-Oncology Development Medical Doctor position reporting to the Head Clinical Development Functional Excellence. This position complements CSPV and GMA efforts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Director , Global Oncology Medical Affairs, Evidence Generation role is responsible for ... using trackers and tools generated by Global Oncology Medical Affairs Study Operations partners and propose mitigation plans for delayed activities. Ensure that… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.SummaryThe Senior Director , Global Oncology Medical Affairs, Evidence Generation role is responsible ... using trackers and tools generated by Global Oncology Medical Affairs Study Operations partners and propose mitigation plans for delayed activities. Ensure that… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in support of Phase I-III clinical studies. Partner with Project Management, Clinical Operations and other functional groups to ensure budgets are always ... for the development and control of functional budget in support of global operations of RD unit. Partner with global function leaders to ensure budgets are… 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, ... Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs,… 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, ... Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads ... mentors and may manage assigned staff, partnering with the Global Labeling Operations & Compliance group and across the cross-functional and cross- regional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations , Clinical Leads ... and Regulatory Liaisons to ensure successful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review of documents supporting CDx submissions to the FDA and other health authorities globallyFor late-stage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with other functional areas such as biostatistics, data management, clinical operations , pharmacovigilance, regulatory affairs, etc. Qualifications: Successful ... of analysis data sets and tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data ... and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes… more
- Merck & Co. (Rahway, NJ)
- …responsibilities include supporting the engineering and maintenance aspects of clinical operations , including support/initiation and gatekeeping of work ... Areas supported include Oral Solid Dosage (OSD) and Sterile operations , the RY119 Development Center, and Global Clinical... operations , the RY119 Development Center, and Global Clinical Supply (GCS) Packaging within the scope of Our… more
