- 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 ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine...Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO, 3rd… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team Leader ... of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections of key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …sub-teams, Global Brand Team, and Global Product Team to inform clinical development , commercialization, market access, and other cross-functional strategic ... research areas centered around rare diseases and immune disorders.Summary The Senior Director, Global Oncology Medical Affairs is responsible for developing the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …tactics and market shaping initiatives including but not limited to KOL development , advisory boards, clinical communications and medical education programs ... member of Mature Business Unit Leadership Team responsible for directing the development and execution of the commercial marketing strategy, inclusive of payer… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a key member of the General Medicine Global Clinical Development team, the Vice President/ Therapeutic Area (TA) Head's primary objectives will ... Therapeutic Area strategy that will bring forth programs to successful approval and registration. Lead late-stage development for our company's assets in this TA… more
- Merck & Co. (Rahway, NJ)
- … Development Associate Principal Scientist - Device Engineering and Early Development Lead (Associate Director Equivalent)Our company's Device Development ... the drug delivery and combination produce space to:Drive pipeline development . Lead the core engineering technical device...development team(s) supporting individual drug assets currently in clinical development with line of sight to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development , an organization dedicated to the effective strategy, design, ... Clinical Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of… more
- Merck & Co. (Rahway, NJ)
- …Molecular Biomarkers (TMB) is responsible for translating preclinical molecular biomarkers to clinical development across all therapeutic areas and all phases of ... clinical development at our Company's Research laboratories....of pathology assays that are deployed in support of clinical trials. The candidate for this Senior … more
- Eisai, Inc (Nutley, NJ)
- …well as the study statistician for clinical studies. As the statistical lead for biomarker development , this individual primarily will be accountable for the ... analysis of human biomarker datasets to inform biomarker identification and validation, clinical development and business strategies. As the study statistician,… more
- Merck & Co. (Rahway, NJ)
- …with applicable regulatory, quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device ... control and risk management techniques to positively support and influence clinical and commercial combination product development and launches.Principal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team Leader ... of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections of key… more
- Eisai, Inc (NJ)
- …a good understanding of other IT systems for contract management and clinical development .#LI-TS1Eisai Salary Transparency Language:The base salary range for the ... to hear from you. Job Summary The Associate Director, Clinical Outsourcing, will oversee and lead and...Lead the process of Request for Proposal (RFP) development through supplier selection and final contract execution on… more
- Merck & Co. (North Wales, PA)
- …an understanding of team and project leadership responsibilities.Applies knowledge of clinical development , relevant regulations, disease areas, and company ... clinical regulatory writing portfolio. With minimal oversight, the Senior Medical Writer:Demonstrates independence in preparing clinical regulatory documents… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director, ... research areas centered around rare diseases and immune disorders.SummarySenior clinical operational leader accountable for operational planning and execution of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …& Simulation plans from FIH to post registration. Responsibilities include the development of Clinical Pharmacology and Modeling and Simulation plans, design ... and lead study teams to execute Clinical Pharmacology... Pharmacology function. The incumbent will champion model-based drug development as an active team member of clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …expert knowledge on safety biomarkers that might be used in preclinical and clinical development by closely collaborating w Research and Precision Medicine. ... This led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to...candidates by the start of the FIH trial (DP1).- Clinical Development and Post Marketing: Consult with… more
- Eisai, Inc (Nutley, NJ)
- …in helping to shape and drive oncology pipeline advancement by coordinating with Clinical Development and Clinical Operations. Essential Functions Work with ... strategies for that therapeutic area.She/He will strategize and execute Phase IV clinical development programs for assigned products.Design and review IIS… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- Merck & Co. (Rahway, NJ)
- …opportunitiesThe Vocabulary Specialist may lead or participate in:Internal clinical data standards forumsStandards development teams and data governance ... Job DescriptionOur Clinical Research and Pharmacovigilance team push the boundaries...across GCDS by actively communicating and proactively sharing informationSupport senior /leadership roles, in areas of observed competence, to enhance… more
- Merck & Co. (Rahway, NJ)
- …in cross-functional teams for the strategic planning and execution for product development and worldwide regulatory submissions. Lead a team of statisticians and ... Involved in research activities for innovative statistical methods and applications in clinical trial development . Education and Minimum Requirement: PhD or… more
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