- Novo Nordisk Inc. (Plainsboro, NJ)
- …actual product Responsible for all areas related to patient safety in clinical trials Act as member of the trial safety group for dose escalation decisions ... external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key...) Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execution: As CSL for Phase 2 studies: Provides input on major milestones of trial , clinical trial plan and contingency planning, Analyzes, updates ... trials of medium to high complexity in design and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execution: As CSL for Phase 2 studies: Provides input on major milestones of trial , clinical trial plan and contingency planning, Analyzes, updates ... trials of medium to high complexity in design and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... leader (CSL)Study Planning and Execution: Provides input on major milestones of trial , clinical trial plan and contingency planning; Analyzes and updates… more
- 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 R&D ... across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions Serve as a member… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in a timely fashion. In addition, the SD serves as a key member of the Clinical Trial Strategy Team, provides additional analytic support to the field team, and ... ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to...training initiatives for the medical affairs team Serve on Clinical Trial Strategy Team to identify investigators/sites… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ensuring that market access considerations and needs are incorporated into future clinical trials , pre-launch, and commercialization initiatives for inline and ... and inputs to shape Global Market Access / Global HEOR strategies and trial design Ensures alignment on access strategy and key account plans and initiatives… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …including evaluation and interpretations of safety and efficacy data generated in the clinical trials and translation of these findings into a benefit-risk ... biotechnology industry experience (including roles in research and development (R&D), clinical trials , regulatory affairs, or medical affairs Leadership… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …investigators is expected. The CS Group Lead will also ensure the writing of high-quality clinical trial protocols, review of clinical data and Clinical ... Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical... Director level for each respective program. This Clinical Science (CS) Group Lead will be responsible for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …may include Medical Affairs, Regulatory Affairs, Marketing, Learning & Development, Clinical Trial Management, and Clinical Development. Essential ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...Nordisk, Inc. RelationshipsThe fellow will report to the Fellowship Director throughout the two-year program and will also have… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …dedicated to the effective strategy, design, execution, and interpretation of Oncology clinical trials . Serves as a primary source of medical accountability ... and oversight for one or more clinical trials Matrix management responsibilities across the...input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …dedicated to the effective strategy, design, execution, and interpretation of Oncology clinical trials . Position Summary / Objective Serves as a primary ... source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provides US market access input to Global and US stakeholders to inform clinical trial programs, guide evidence generation development, payer value stories, and ... ensure fact-based decisions are generated. Relationships Reports to the Senior Director , Rare Value Communications & Pricing. Interacts internally with team… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …scenarios and strategy for all pipeline products starting in Phase II clinical trials . Generates insights to support G3 decision-making Assesses investments ... for aligned therapeutic / franchise area(s). Relationships Reports to the Director /Senior Director of Value Communication and Contracting Strategy. Interacts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sciences, Global Clinical Operations, Biostats and Data Management and Clinical Development.Responsibilities:Designs and leads clinical trial sample ... regulatory submission or associated drug regulatory submissionsResponsible for implementation of clinical trial assays at Diagnostics Partners, reference labs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …non- clinical and clinical factors, diagnosis, effective management during clinical trials and beyond in post approval setting.Responsible for the ... CSPV and other internal groups) and outside of Daiichi Sankyo (eg clinical trial sites, CROs, collaboration partners); Supports effective direct communication… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in clinical trials required.Demonstrated ability to define clear clinical trial translational strategies anchored in disease biology and drug mechanism ... enumerate key translational hypothesis that will drive scientific decision-making both from non- clinical and clinical translational aspects. In doing so, he or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Research (CESR) projects. Candidates should have a comprehensive understanding of clinical trial management, with firsthand experience managing collaborative ... action items. Coordinate with stakeholders to ensure timely follow-up and resolution of issues. Clinical Trial Management: Oversee clinical trial … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in...a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to achieve goals preferredExperience with publication planning requiredExperience with clinical trials and international work experience preferred TravelAbility ... research areas centered around rare diseases and immune disorders. Summary Director , Global Medical Affairs Oncology Publications works with Cross Functional Team… more
