- 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 . 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)
- …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)
- …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
- Merck & Co. (Rahway, NJ)
- …provide resources and services that are critical to the success of Global Clinical Trial Operations (GCTO) and Global Clinical Development (GCD) objectives and ... are developed to meet those identified needs.Evaluates and advises clinical teams on strategy of adding a new supplier...or other initiatives to meet business needsMay plan and lead the transition activities related to managing an existing… 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)
- …Center in Rahway is looking for an Associate Director - Process Engineer to lead clinical supply manufacturing, scientific rigor of processes, and ultimately to ... and clinical manufacturing facility in Rahway, New Jersey.- This team works with non-sterile formulations, typically oral solid dosage (blending, roller… more
- Merck & Co. (Rahway, NJ)
- …development projects; and assist the Associate Vice-President/Vice-President and product development team lead in ensuring that appropriate corporate personnel ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility...as the ability to work collaboratively in a cross-functional team environmentNOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy… 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
- Merck & Co. (Rahway, NJ)
- …Late Stage Analytical Program LeadAbout the roleYou will join our Large Molecule Analytical Validation team to serve as an Analytical Program- Lead . The lead ... development to commercialization as part of the Development and Commercialization Team . The incumbent should apply stage appropriate scientific rigor, ensure… 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)
- …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
- 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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. SummaryAs a member of the Executive Leadership team for DS US Oncology Business Division, the Vice President, Medical Affairs ... direction and long-term vision for the Company. The position will also lead the Medical Affairs organization which is responsible for providing impactful medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of new and updated Core Data Sheets, EU and US Documentation: As the project lead , Independently or through direction of a team of GLLs, manage, develop prepare ... oversight of a team of GLLs, prepare labeling documents for review. Lead review processes to ensure appropriate review and governance by Daiichi Sankyo, and… more
