- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. The Sr. Manager is to lead collaboration efforts with R&D IT to implement and maintain Eisai's global (Veeva) e TMF ... overseeing the daily global eTMF system related activities relating to clinical study Trial Master Files (TMF), ensuring regulatory inspection-readiness and… more
- Eisai, Inc (Nutley, NJ)
- …and medical affairs to align strategies, and partners with HEOR field team in customer research activities and development of external communication materials. The ... of healthcare resources, and an advocate for patient access to appropriate therapeutic alternatives. Lead and direct all aspects of HEOR and RWE projects to meet the… more
- Eisai, Inc (Nutley, NJ)
- …office-based (hybrid) in Nutley, NJ. Essential FunctionsSummary of Job Responsibilities: Lead and executekey omnichannel projects within the HCP Neuro omnichannel ... effective roll out of marketing campaigns to the field team through plan of action (POA) meetings and build...changes Ability to take on board new and complex clinical information and adapt it strategy Experience in neurodegenerative… more
- Merck & Co. (Rahway, NJ)
- … protocol(s).Serves as the lead clinical scientist on the clinical trial team .Collaborates with the Medical Writer on clinical /scientific and ... Program Lead , you will collaborate with global, cross functional team members including clinical directors and study managers to lead /support clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …standards. The Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO, 3rd Party Vendor Management and ... accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study...solutions, or bring to the attention of the operations lead of study team lead .… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …employer including veterans and people with disabilities. SummaryThis position will be the Clinical Science Group Lead in late phase development in the Global ... the Senior Director level for each respective program. This Clinical Science (CS) Group Lead will be...multiple program-level CS Asset Leads who are managing a team of clinical scientists for the writing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead . ResponsibilitiesStudy Strategy: Clinical study leader (CSL) ... Develops program biomarker strategy; Achieves endorsement for plan by function and team ; Interprets and react accordingly to new preclinical/ clinical data(eg;… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead . Responsibilities:Study Strategy: Clinical study leader (CSL) ... Develops program biomarker strategy; Achieves endorsement for plan by function and team ; Interprets and react accordingly to new preclinical/ clinical data(eg;… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies, conduct hands on ... function. The incumbent will champion model-based drug development as an active team member of clinical and development teams.ResponsibilitiesResponsible for all… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with ... 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. (Bernards, NJ)
- …rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all ... and Medical Access/Expanded Access (MAP)/(EAP)activities in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and… more
- Merck & Co. (Rahway, NJ)
- …At our company, we're shaping the future of health. We're seeking a Clinical Database Developer who will be instrumental in creating and developing clinical ... role provides a unique opportunity to contribute to a team that is delivering innovative solutions for the prevention...Your primary role will be to create and develop clinical databases and data transfer files, ensuring they align… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including, Publications Planning, Clinical and Safety sub-teams, US and Global Brand Team , and US Product Team to inform clinical development, ... USOMA plan including Launch Readiness and Life Cycle Management. Leads the team for this compound.Responsibilities- Responsible for the development of the USOMA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …that includes veterans and people with disabilities.Summary Reporting to the Disease Area Strategy Team (DAST) Lead for GYN Cancer, this position is integral to ... R&D and partners with the DAST Lead to build and execute a disease area strategy...pull-through of the disease area strategy through collaboration with clinical development team (ADC portfolio plus emerging… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Team . In addition, he or she will interact with the Companion Diagnostics Lead , Non- Clinical Research, Medical Affairs and other stakeholders to support the ... translational deliverables (eg data, reports, and communications) to the Global Project Team to drive scientific decision-making both from non- clinical and … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution ... lead the development and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of the other sections in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …needed- Clinical Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of ... management of adverse events based upon approved Safety Management Team (SMT) materials- Supports overall program safety reporting (eg,...and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical Affairs' externally ... sponsored clinical research...from initiation through completion.Operational Strategy: Develop and implement ESR team operational strategies for externally sponsored studies. Serve as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …biosample tracking for the assigned studies in close collaboration with the QCP, Clinical Biomarker Team , Companion Diagnostics, the Clinical Study Teams, ... of the end-to-end lifecycle of biosamples (PK/ADA , CDx and biomarker) in clinical trials from study start-up to close-out including but not limited to near… more
- Merck & Co. (Rahway, NJ)
- …Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team that will build ... teams, building talent, and shown to be able to motivate, influence scientific team ; lead by example through past scientific / technical expertise).Highly… more
