- Daiichi Sankyo, Inc. (Bernards, NJ)
- …certain regulatory documents. Responsibilities:Develop and implement a hypothesis driven translational strategy for clinical assets and cross-asset in specific ... defining key scientific questions and plan. Align closely with the Senior Translational Strategy Lead.Construct translational plan documents, biomarker data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …position (GRL Oncology) is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan, ... a multidisciplinary Global Regulatory Team (GRT) to develop global regulatory strategy and plans for assigned global projects.Gain endorsement from the Global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …group and high-complexity disease work to support critical strategic choices for the clinical program. The DAST Director will collaborate with the DAST Lead ... fabric of Daiichi Sankyo.Responsibilities- Facilitate pull-through of the disease area strategy through collaboration with clinical development team (ADC… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science ... and aligned guidance to asset teams to enable seamless tumor-specific clinical development and strategy .Responsibilities- Accountable for developing the Global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated ... to the effective strategy , design, execution, and interpretation of Oncology clinical trials. Serves as a primary source of medical accountability and oversight… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated ... to the effective strategy , design, execution, and interpretation of Oncology clinical trials. Position Summary / Objective Serves as a primary source of medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy : Provides the ... 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. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.SummaryThe Senior Director , Global Oncology Medical Affairs, Evidence Generation role ... country strategies across all relevant functions and aligns with the Disease Area Strategy . Ensure alignment of the gap assessment, gap prioritization and IEP with… more
- Merck & Co. (North Wales, PA)
- …with talented and dedicated colleagues while developing and expanding your career.The Senior Clinical Director (Sr. Principal Scientist) has primary ... team. Our Company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will manage the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with ... in the US and abroad, governmental, academic, community and industry organizations. The Senior Clinical Study Manager role is primarily a tactical study delivery… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position develops strategy , prepares content templates and leads technical teams in preparation ... of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing...cross-functional teams on US/EU RA CMC project issues.Execution of Strategy and Submissions: Develops strategy with supervision.… more
- Daiichi Sankyo, Inc. (Bernards, 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)
- …your potential? The Position Leads value communication and pricing and contracting strategy for a key Novo Nordisk product category. Ensures alignment between the ... value communication and contracting strategy teams in order to set and meet product...MASH. Interacts frequently in collaboration with internal management and senior level managed markets customer representatives. Interacts internally with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …/ franchise area(s). Relationships Reports to the Director / Senior Director of Value Communication and Contracting Strategy . Interacts frequently in ... your potential? The Position Develops and executes the pricing and contracting strategy for a key Novo Nordisk product category. Collaborates with internal and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …addressed and managed appropriately. Ability to exercise influence at the senior leadership and/ or executive level wherever GLP/non-GLP/ research programs impacting ... broad range of colleagues in order to establish a globally aligned GCLP/GLP strategy across DS teams. Establishes and / or develops operational resource strategy… more
- Merck & Co. (Rahway, NJ)
- …the oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy , lead activities, and develop a ... approach, driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …decision-makers across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions ... 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… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to internal and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key ... the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future,...within the US East Coast Development Hub comprised of Senior Global Safety Leads, Global Safety Leads and … more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy , lead activities, and develop ... opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of robust compositions,… more
- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director / Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for ... support for anticipated promotional messages and claims (aligned with marketing strategy ) in clinical trial design and product labeling as it relates to the… more
