- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as other research areas centered around rare diseases and immune disorders.SummaryThe Senior Director of Clinical Operations will manage clinical ... in place for each CRO to best support each program . This position will require line management responsibility of...operational and overall delivery and tactical execution of the clinical studies. The senior director … more
- Insmed Incorporated (Bridgewater, NJ)
- …lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of Pharmacovigilance QA serves as a strategic partner ... other related activities performed by Drug Safety & Pharmacovigilance and Medical/ Clinical Departments. The incumbent will provide support and promote collaboration… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Coordinates clinical activities across the project; Represents IPT to Sr . ManagementAdditional non-study related activities: Provides input on KEE selection for ... diseases and immune disorders.SummaryOversees a number of trials of a multinational program in a specific indication, ie, multiple multinational phase II/III … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head has ... all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for ensuring the...in role such as a Global Project Leader at Sr . Director level or equivalent preferred- Relevant… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …functional group and high-complexity disease work to support critical strategic choices for the clinical program . The DAST Director will collaborate with the ... - Facilitate pull-through of the disease area strategy through collaboration with clinical development team (ADC portfolio plus emerging pipeline assets) and key… 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 ... study team, external service providers (CROs, vendors, etc.) and clinical sites to ensure all trial deliverables are met...financial metrics on an ongoing basis to study and program teams. In collaboration with internal and external partners,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Leaders/National Expert Panels for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead Support investigator ... (KOLs), Healthcare Professionals (HCPs), and other stakeholders. The Medical Director will also assist the Senior Medical... Clinical Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director ,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …functional group and high-complexity disease work to support critical strategic choices for the clinical program . The DAST Director will collaborate with the ... Facilitate pull-through of the disease area strategy through collaboration with clinical development team (ADC portfolio plus emerging pipeline assets) and key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , ... and Phases 1-3 clinical trials at the study and program level. Responsible for clinical program planning and execution (from study design, operational… more
- Merck & Co. (Rahway, NJ)
- …approaches to develop and implement translational PK/PD strategies, characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities and ... biologics, and inform dose selection and go/no-go decisions. Senior Directors lead QP2 efforts to strengthen our pharmacometric capabilities on a continuous basis by… more
- Merck & Co. (North Wales, PA)
- …and execution elements (eg operational reviews, issue escalation/mitigations, presentations at Sr . Management meetings, program level cross functional meetings ... the strategy and leads the operational planning and execution of one or more clinical trials. In this position, you will have the opportunity to demonstrate your… 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 ... for the assigned GMA plan activities, in collaboration with Sr Director .Leads medical readiness activities for market...and other scientific exchange activities in alignment with the Senior Director , such as scientific symposium and… more
- Merck & Co. (Rahway, NJ)
- …new milestones in global healthcare. Our company's Pharmaceutical Sciences & Clinical Supplies organization translates molecules to medicines, working from the ... a range of modalities including small molecules and peptides.- Within OFS, the Director will influence the strategy, lead activities, and develop a team whose roles… 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 ... the Corporate Compliance & Privacy Officer in setting the strategy and program requirements for the Corporate Compliance and Government Accountability Programs. The… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 ... independently in order to accomplish objectives. Relationships Reports to the Director , Patient Support Programs Rare Disease. Key internal relationships include… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a non-project initiative in support of these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director , US Head ... execution of the integrated product development plan.Partners with the Clinical Team Leader to ensure a high performing ...the project environment to address gaps that impact the program /project.Manages the planning and use of program /project… more
- Insmed Incorporated (Bridgewater, NJ)
- …adhering to corporate policies and external regulations and guidance. The Senior Manager, Scientific Communications & Publications, provides support to the Associate ... Director / Director for the development and execution of...include research and development, health economics and outcomes research, clinical development, marketing, biostats, corporate communications, and medical affairs… more
- Merck & Co. (Rahway, NJ)
- …scientific leader for the role of Distinguished Scientist which is an Executive Director level reporting to an Associate Vice President in Development Sciences & ... Clinical Supply . The Distinguished Scientist will provide scientific...with a particular focus on digital upskilling and enablement.Maintaining recognition as an internationally known expert in their field… more
- Insmed Incorporated (Bridgewater, NJ)
- …teams, collaborating with subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC, and program management to drive the ... management regarding the potential impact of toxicology results on Program and Clinical /Regulatory strategy.Author nonclinical sections in regulatory submission… more
