- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for developing the Global Clinical Science Strategy and delivery of clinical studies in late stage development. Lead and manage the multiple late development ... multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science...of Ph1-Ph3 studies, including assets transitioning from early to late stage . preferred TravelAbility to travel up… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in Lexington, MA and Plainsboro, NJ. We support programs from early research through late - stage clinical development. We are building for the future, creating a ... lives for a living. Are you ready to make a difference?The Position The Director , Medical Writing is an expert in medical writing and performs work independently… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …manager/leader in planning and executing strategies for global drug development: early stage , late stage and life cycle management preferred10 or More ... The Sr Director GPM&L is accountable for delivering an integrated drug development strategy and tactical plan including options analysis of team's proposals in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late - Stage Development Portfolio. The individual will play a key role in ... supporting CDx submissions to the FDA and other health authorities globallyFor late - stage programs, executes the Diagnostic development strategy for a project… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in Lexington, MA and Plainsboro, NJ. We support programs from early research through late - stage clinical development. We are building for the future, creating a ... incumbent will help develop multiple products. In doing so, the Senior Medical Director will work across different functional teams to support the design and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … of the project. The CMC Lead will support the Sr. CMC Lead on complex and/or late - stage project or act as main CMC Lead of an early- stage project. He/she ... and management to drive strategies and activities for early and late phase drug development candidates within the team to support overall CMC development… more
- Eisai, Inc (Exton, PA)
- …also serve as a scientific and technical resource to support several early to late stage manufacturing programs.This position will be responsible for the review ... from pre-IND through phase 3, knowledge of the regulatory requirements at each stage of clinical development is essential.This position will have a direct impact on… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …development of clinical biomarker assays and vendor selection for early and late - stage Daiichi Sankyo projects. Effectively identify, manage, and communicate ... of industry experience post degree. Candidates must be experienced in oncology drug development.Must have at least 5 years' experience in fit-for-purpose clinical… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …functions including discovery sciences, preclinical development groups, toxicology, clinical operations, drug metabolism, regulatory affairs, and late - stage ... Senior Director of Translational Medicine and Clinical Pharmacology Sun...study support staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global… more
- Genmab (Princeton, NJ)
- …promote effective Team performance Drive LCM strategies that support future value of a late stage asset through LoE Key contributor for all health authority ... R&D functions (preclinical, clinical, regulatory, CMC) Clinical development experience required; late - stage clinical experience is preferred Hands on BLA/NDA… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in Lexington, MA and Plainsboro, NJ. We support programs from early research through late - stage clinical development. We are building for the future, creating a ... stakeholders. Relationships This position will report to Senior Global Safety Lead/ Director /Senior Director - Safety Surveillance, US East Coast Development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in Lexington, MA and Plainsboro, NJ. We support programs from early research through late - stage clinical development. We are building for the future, creating a ... of a clinical program. Relationships The Senior Medical Writer reports to a Director of Medical Writing. The Senior Medical Writer is expected to develop and… more
- Boehringer Ingelheim (North Brunswick, NJ)
- **Description** Director , Late - Stage Drug Product Development with Boehringer Ingelheim Animal Health USA, Inc. in North Brunswick, NJ (Telecommuting ... the time) Job Duties: Provide leadership, training, and supervision of the local Late - Stage Drug Product Development (LSDPD) team plus complete and maintain… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …MTPA's commitment to patients and their communities continues with a robust late - stage pipeline of investigational treatments for difficult-to-treat diseases and ... regulations. The incumbent will lead the successful delivery of late - stage clinical milestones for the company, drawing...drug development processes. He/she will lead The Senior Director , MSLS will be responsible for MSLS strategy, clinical… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …MTPA's commitment to patients and their communities continues with a robust late - stage pipeline of investigational treatments for difficult-to-treat diseases and ... translating regulatory requirements into practical, workable plans to facilitate timely drug development and registration. The Senior Director , Regulatory… more
- AbbVie (South San Francisco, CA)
- …Instagram, YouTube and LinkedIn. Job Description The Product Safety Team (PST) lead for late stage oncology products, under the direction of the Group Lead and ... safety surveillance + Responsible for safety surveillance for pharmaceutical / biological / drug -device combined products + Lead and set the strategy for key… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …MTPA's commitment to patients and their communities continues with a robust late - stage pipeline of investigational treatments for difficult-to-treat diseases and ... and in creating and implementing experimental medicine studies. Reporting into the Senior Director of the Medical Science Early- Stage , the Director , MSES… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …evidence of success for obtaining EOP2 and/or MAA/NDA. + Proven history of early- stage drug R&D successes as evidenced in documented regulatory success ... to patients and their communities continues with a robust late - stage pipeline of investigational treatments for difficult-to-treat...As a senior member of Medical Science, the Senior Director , Medical Science - Early Stage will… more
- Takeda Pharmaceuticals (Boston, MA)
- …to patients worldwide. Join Takeda as a Scientist - Analytical Development (AD) - Late Stage Development where you will independently lead efforts in development ... demonstrate an in-depth working knowledge of program strategy. Experienced with working on late - stage assets and with various regulatory agencies + Knowledge of… more
- Bristol Myers Squibb (Cambridge, MA)
- …also serve as part of a PM team supporting workstreams of a large, highly complex late stage GPTs with oversight of a Senior PM. + Accountable for creating and ... a BMS Global Program Team (GPT) in early and/or late development. The Associate Director PM will...of planning and managing complex programs in early and/or late phase drug development with solid understanding… more
