- Daiichi Sankyo, Inc. (Bernards, NJ)
- …level time, cost and quality deliverables. Lead the development of the clinical study plan including critical path activities and interdependencies for ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic...assigned clinical study (-ies) utilizing Microsoft Project or equivalent. Lead … more
- Merck & Co. (Rahway, NJ)
- …Director, PDT Lead will manage the entire cycle of clinical development, including development strategy, study design, initiation, execution, monitoring, ... safety and efficacy as well as new drug applications, clinical study reports, or publicationsParticipation in internal...entire Clinical Teams in the execution of clinical studies .--Will report to and work collaboratively… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … group regarding new indications for Life Cycle Management.Additional non- study related activities: Clinical Development involvement in due diligence ... a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of...documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …resolve or escalate to appropriate Governance Committee. Analyze CRO performance trends within a clinical study or across several studies and resolve or ... clin pharm patient studies , and Phases 1-3 clinical trials at the study and program...as well as programs or franchises.When sitting on a study team, lead the study … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Study Supply Plans in close communication with CSO project Management Lead .Responsible for the Clinical Label Development process which includes creation of ... Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of...position is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This role is… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution ... with Clinical Scientists (CS)Interpretation and presentation of clinical study (ies) data to internal and external...and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL) Study Planning and Execution: Provides ... Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of...size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …management, and provide safety leadership including but not limited to clinical studies , post-marketing surveillance, signal detection and management, important ... areas centered around rare diseases and immune disorders.SummaryThe Director, Clinical Safety, will be a product safety lead...the Global Product Team or specific sub-teams such as clinical study team and submission team, providing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …concerning risk control and reporting under RBQM Central Statistical Monitoring during study conduct to detect oddities, trends in clinical variables, or ... drivers of enhanced quality.Aligns with the RBQM Risk Management Lead on critical-to-quality factors and study -level critical...of RBQM Standards, Tools and TrainingEnsure Daiichi Sankyo RBQM study level practices for RD studies comply… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …reporting requirements that adhere to programming standards and specifications across clinical studies . This position involves managing direct reports and/or ... and external data acquisition and validation deliverables for all studies consistent with IDRP, study data listings,...ensure complete, high-quality data is available for use by clinical study teams in a timely manner.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of...rare diseases and immune disorders. Summary Position leads complex studies in study design, statistical analysis and… more
- Merck & Co. (Rahway, NJ)
- …offers an opportunity for the Pharmacometrics leader to drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to ... enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced leadership team, deep modeling… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve ... to a strong portfolio of medicines for cardiovascular diseases, under the Group 's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage… more
- Merck & Co. (Rahway, NJ)
- …outlined in applicable regulationsAnalysis of peer-reviewed literatureReview of clinical study dataParticipation in risk communication planningParticipation ... Acceptance Tests (UATs) for functionality changes)Perform literature searchesFunction as Content Lead for one or more GPV sub-teams (eg, training, risk management,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …time, cost and quality deliverables. + Lead the development of the clinical study plan including critical path activities and interdependencies for assigned ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic...+ Lead the creation of the cross-functional Clinical Study Oversight Plan (CSOP) under the… more
- Sanofi Group (Morristown, NJ)
- …results + Comply with company standards & local regulations Design and Oversee Clinical Studies + Be the strategic lead in the development of clinical ... oversight and approval of the protocol, Key Results Memo, Clinical Study Report and for other ...medical input & support for all activities related to clinical studies such as medical training, feasibility,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …resolve or escalate to appropriate Governance Committee. Analyze CRO performance trends within a clinical study or across several studies and resolve or ... clin pharm patient studies , and Phases 1-3 clinical trials at the study and program...as programs or franchises. + When sitting on a study team, lead the study … more
- Bristol Myers Squibb (Madison, NJ)
- …members of the study team for the day-to-day oversight and conduction of the clinical studies included in the BOW for an asset in the Cell Therapy portfolio. ... manages the evidence generation for the CT portfolio (including Medical Affairs Sponsored studies [MAST]) and provides clinical support for other studies … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead , Product Safety Lead (PSL), Clinical ... lifecycle * Independently leads activities without supervision for assigned clinical studies * Lead activities... studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and review Statistical… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead , Product Safety Lead (PSL), Clinical ... lifecycle. + Independently leads activities without supervision for assigned clinical studies . + Lead activities... studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and review Statistical… more
