- 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
- 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)
- …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. (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)
- …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)
- …clear and sustainable platform of evidence generation, design and leadership of clinical development plans, and addressing all regulatory, drug and patient ... diseases and immune disorders. Summary The Global Team Leader, is a senior , cross-functional leader in Daiichi Sankyo's Global R&D organization. At Daiichi Sankyo,… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.SummaryThe Senior Director, Global Oncology Medical Affairs, Evidence Generation role is ... of working in collaboration with a strategic alliance partner.Responsibilities- Co- lead a cross-functional Evidence Generation Team (EGT) for the assigned… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, NJ)
- … Clinical Quality Management or other RD business process owners that applicable clinical development processes and quality standards which are in line with ... ensure adherence to regulatory compliance.Monitor effectiveness of implementation of applicable clinical development processes through KQIs in collaboration with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the Senior Director, GMA Oncology ADC (Global Medical Affairs team lead for ... medical affairs projects within a specific compound or indication.ResponsibilitiesLeads the development of the Global Medical Affairs strategy and execution of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Facilitate pull-through of the disease area strategy through collaboration with clinical development team (ADC portfolio plus emerging pipeline assets) ... plus emerging pipeline assets to advance our research and development . This role will lead workstreams with...to the disease strategy and the strategic choices for clinical development and data generation- Develop and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Facilitate pull-through of the disease area strategy through collaboration with clinical development team (ADC portfolio plus emerging pipeline assets) ... plus emerging pipeline assets to advance our research and development . This role will lead workstreams with...to the disease strategy and the strategic choices for clinical development and data generation- Develop and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the Senior Director, GMA Oncology (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/program medical strategies ... Medical Affairs projects within gynecological oncology indications.Responsibilities:- Leads the development and execution of the Global Medical Affairs strategy for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of epidemiologic studies, including real-word evidence (RWE), supporting senior management in various epidemiological activities.This position independently carries ... preparation of data for statistical analysis to obtain background rates) for development of safety documents (eg, RMP), support SMTs, SERM or other safety-related… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …As a result, this role will need to partner closely with teams and senior leaders from across Regulatory Affairs, as well as cross-functional stakeholders (eg, RA ... CMC, R&D Excellence, Clinical Operations, IT).Responsibilities Operate within and in support of...into technical specifications and data models to guide the development of reporting and analytics solutionsUtilize fit-for-purpose analytics tools… 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
