- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , ... 1-3 clinical trials at the study and program level. Responsible for clinical program...planning and individual protocols to facilitate successful implementation of programs . Clinical OperationsEnsure high quality delivery of all… more
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, NJ facility for an experienced MD to serve as Senior Director or Director , Clinical Development. Title and salary commensurate with ... direction and oversight of the clinical development function and company clinical programs . ESSENTIAL FUNCTIONS Responsible for generation of key study… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, NJ)
- …diseases and immune disorders.SummaryOversees a number of trials of a multinational program in a specific indication, ie, multiple multinational phase II/III ... clinical trials; Reviews regulatory documents from cross functional, holistic...management and performance of CRO. Occasional interactions with CRO senior leadership as needed; Participates in creation of developmental… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) ... to ensure consistency in support between studies in one or several programs .Partner and collaborate with RD leaders in Clinical Operations, Biostatistics… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Director , Global Clinical Trial Operations (GCTO) Project Management Office (REMOTE) The core responsibility of this role is ... independently direct the execution and coordination of major change projects across Global Clinical Trial Operations (GCTO). The role will also contribute to the … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …science innovation with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are ... will help develop multiple products. In doing so, the Senior Medical Director will work across different...with the VP Medical/Scientific Development, Clinical Operations, Non- Clinical Research, Medical Writing, Program Management, CMC… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Senior Medical Director of Gene Therapy will develop, implement, and ... milestones in launch planningMedical leadership input for cross functional partners including clinical , operations, HEOR and commercial to ensure that there is a… more
- Insmed Incorporated (Bridgewater, NJ)
- …teams, collaborating with subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC, and program management to drive the ... senior management regarding the potential impact of toxicology results on Program and Clinical /Regulatory strategy. Author nonclinical sections in regulatory… more
- Insmed Incorporated (Bridgewater, NJ)
- …support in medical affairs activities, collaborating closely with Biometrics senior management and key business stakeholders.Provide leadership, guidance and ... collaboration across Biometrics and cross-functionally, while effectively communicating with senior executives.Act as the statistical representative in key cross-functional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global ... business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements are in place for… 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...and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …deliverables that support the clinical development and regulatory requirements of a clinical program . The Director will provide high level strategic ... facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical ...Writing team. Relationships The Director Medical Writing ( Director ) reports to a Senior Director… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Analytics functions and translating into business impact. Relationships Reports to the Senior Director , Enterprise Functions Insights Lead with direct management ... to maximize your potential with us? The Position The Director , CMR Insights Lead is responsible for leading the...drive organizational action, guide the Business units and the Clinical , Medical, and Regulatory Affairs (CMR) teams on strategy… more
- Tris Pharma (Monmouth Junction, NJ)
- …Pain specific clinical development and provides strategic guidance for Pain clinical programs to ensure clinical activities utilize cutting-edge trial ... expertise in the Pain therapeutic area to serve as Senior or Executive Medical Director . Title and... provides leadership, direction and medical expertise for company’s clinical development programs specifically focused on the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … development/trials Experience leading cross-functional teams in the execution of clinical trial portfolios/ programs preferred Expert in ICH-GCP principles and ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...financial metrics on an ongoing basis to study and program teams. In collaboration with internal and external partners,… more
- Merck & Co. (Rahway, NJ)
- …and/or medical device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- ... and risk management techniques to positively support and influence clinical and commercial combination product development and launches.Principal ResponsibilitiesLead… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Interacts with our Discovery and Research programs for development of early clinical studies. Provides senior level clinical representation at meetings ... rare diseases and immune disorders. Summary Oversees early-stage trials, such as global clinical development program for multiple product candidates with one or… more
- Eisai, Inc (Nutley, NJ)
- …planning and supportive tactics for assigned therapeutic area. Under the direction of the Senior Medical Director , this role will be responsible for working with ... strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs...Medical Affairs Strategic Plans: Under the direction of the Senior Medical Director , work with key stakeholders,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …initiative in support of these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director , US Head GPM&L. ... 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
