- 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
- 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)
- …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)
- …& 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
- Merck & Co. (Rahway, NJ)
- …and program for a defined functional area(s) (single point of contact) within Clinical Supply, including support for System Development Life Cycle deliverables ... our company's Research Laboratories Quality Assurance community, provide for and lead Quality Assurance oversight for computer system validation matters within the… 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
- Merck & Co. (Rahway, NJ)
- …potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned ... Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work… 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
- Merck & Co. (Rahway, NJ)
- …and provides biostatistical support for related drug/vaccine projects in Late Development Statistics. Lead the interaction with Clinical , Regulatory, ... to a development project as neededLead biostatistics in early or late clinical development planning to ensure that study designs are consistent with program… 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
- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the competitive landscape, market research, historical products, and payer landscape. Lead market development and unbranded activities for the therapy area ... Product Evolution: Oversee product strategy and regulatory activities related to new clinical data or label changes. Lead modification to marketing strategies… more
- Merck & Co. (Rahway, NJ)
- …robust and scalable upstream processes for biologics in different stages of clinical development , 2) process characterization and regulatory filings for ... achieve this, we work closely with colleagues in Discovery, Pre- clinical , Early Development , Analytical, Formulation, and Commercial Manufacturing… 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
- Merck & Co. (Rahway, NJ)
- …closely with US RDMAs and others in GMSA TAs, US Health Systems, Global Clinical Development (GCD), Global Clinical Trial Operations (GCTO), Global Medical ... Metabolism (ED CVM) within US Medical Affairs (USMA) will lead the USMA field medical (FM) teams supporting CVM...for all US FM strategic planning and FM capabilities development in support of our CVM pipeline.- The ED… more
