- 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
- 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
- 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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Interaction & Collaboration level: Requires interaction with vendors and key senior stakeholders at Sr manager and director level in ... etc )Responsibilities Interaction & Collaboration level: Requires interaction with key senior stakeholders at director level and above cross functionally… more
- Merck & Co. (Rahway, NJ)
- …Scientist is a senior scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in ... technical personnel, leading projects, and defining group or departmental strategy will aid in distinguishing candidates.--An established reputation for scientific… more
- The Cigna Group (Morris Plains, NJ)
- **Job Description** The Senior Director , Clinical Consulting serves as a clinical strategy leader and trusted advisor for Prime Therapeutics within ... the clinical account management function of the Strategic Markets Sales...clinical business strategies (formulary, utilization and/or health management strategy , support for client P&T and Business Committee meetings)… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …evidence, and creating hope for all facing illness. As a senior member of Clinical Operations, the Senior Director , Clinical Operations will lead the ... objectives leading to submission for world-wide marketing applications. The Senior Director , Clinical Operations will...with the Execute Director and the VP, Clinical Operations to make recommendations for MTPA's strategy… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director Clinical Development - Respiratory Date: Aug 31, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals ... be based in Parsippany, NJ or West Chester, PA Senior Director , Clinical Development is...development plan and will provide leadership for assigned asset strategy , working closely with other functional areas such as… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …documents. **Responsibilities:** + Develop and implement a hypothesis driven translational strategy for clinical assets and cross-asset in specific tumor ... indication/s, defining key scientific questions and plan. Align closely with the Senior Translational Strategy Lead. + Construct translational plan documents,… more
