- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders.Summary The Senior Director sits within Global Oncology Clinical Development , an organization dedicated to the effective strategy, design, ... medical guidance for coding of AEs, medical history, and medications when needed- Clinical Development Expertise Strategy- In collaboration with the Global … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and global stakeholders, the Director of S&PE will establish the North America Clinical Development (NACD) strategy for the development and execution of ... Operational Excellence & Delivery function (OED) is seeking a Director of Site & Patient Engagement (S&PE). In collaboration...experience P referred 5 years of team leadership in clinical development /trials Expertise in ICH-GCP principles and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …hard work and dedication with the opportunity for continuous learning and personal development . Are you ready to realize your potential? The Position Responsible for ... Compliance, Finance, HEOR, and Market Research. The position has high exposure to senior management and requires a highly motivated individual who is able to work… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Clinical Operations and Marketing Effectiveness. Strong collaborations with senior leaders from Legal, Finance, Operations and Market Access as well ... disclosures, PDMA requirements and any NNI specific government agreements. Manages the development of the annual plan to meet NNIs government obligations including… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …products for aligned therapeutic / franchise area(s). Relationships Reports to the Senior Director of Value Communication and Contracting Strategy Interacts ... frequently in collaboration with internal management and senior level global stakeholders Interacts internally with Strategic Pricing & Contracting, Finance, Brands,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , Clinical ... 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)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science ... long-term). These will include but not limited to Group Heads in Clinical Development , Asset & Portfolio Management, Global Clinical Operations, BDM and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections of key ... matters; Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Senior Director , Global Oncology Medical Affairs is responsible for ... sub-teams, Global Brand Team, and Global Product Team to inform clinical development , commercialization, market access, and other cross-functional strategic… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …aspects of Clinical Pharmacology and Biopharmaceutics studies and model-based drug development plans, serves as QCP subteam leader / clinical pharmacology ... The primary responsibilities of this position are to create the model-based drug development plan, design, conduct, and interpret Phase 1 (specifically Clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Associate Director will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from FIH to post registration. ... Responsibilities include the development of Clinical Pharmacology and Modeling and...project team members, and to a limited extent with senior management, and outside vendors; works independently for all… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction ... US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily...study level time, cost and quality deliverables. Lead the development of the clinical study plan including… 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)
- …as early as possible. This led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to Daiichi Sankyo's global ... a first, preliminary benefit/risk assessment and make available to senior leadership at DP0. Surface expert knowledge on safety...safety biomarkers that might be used in preclinical and clinical development by closely collaborating w Research… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections of key ... matters; Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.SummaryThe Senior Director , Global Oncology Medical Affairs, Evidence Generation role ... of the progress includes the stakeholders at the Alliance Partner.- Drive the development of Areas of Interest (AOI) for Externally Sponsored Research (ESR). Align… 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 education and other scientific exchange activities in alignment with the Senior Director , such as scientific symposium and medical congresses, within… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within ... and resource strategies for a VP Function of the Clinical Development , Medical & Regulatory Affairs (CMR)...of best practices. Relationships The Manager, reports to the Director , CMR Business Planning & Strategy. The incumbent works… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …, Global Medical Affairs (GMA), Gyn Oncology, under the direction of the Senior Director , GMA Oncology (Global Medical Affairs team lead for compound), ... Medical Affairs projects within gynecological oncology indications.Responsibilities:- Leads the development and execution of the Global Medical Affairs strategy for… more
