- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study Team Leader for the assigned ... and immune disorders.SummaryThe incumbent will be responsible for ensuring execution of clinical studies across geographic regions, in adherence to Good … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies , conduct hands on population PK and PKPD analyses and ... an equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL) Study Planning and Execution: Provides ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle...safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic... trial performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director… more
- Merck & Co. (Rahway, NJ)
- …to join the Quantitative Pharmacology and Pharmacometrics - Immune/Oncology team in the role of Associate Director . The team is part of the Global Clinical ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the Group will work closely with teams of… more
- Merck & Co. (Rahway, NJ)
- …innovation and improve lives. -Position Description: Under the guidance of the Oncology Clinical Development Finance Associate Director , the Finance Senior ... and analytical support to our Research & Development Division Oncology Clinical DevelopmentForecast grant spend as well as provide financial support related… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction ... of the Senior Director , GMA Oncology (Global Medical Affairs team lead for...as medical lead for select company-sponsored GMA evidence generating studies /projects. Manages all medical aspects such as study… more
- Merck & Co. (Rahway, NJ)
- …simultaneously. Review and provide final approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Confidential Investigator Brochures before ... to GRACS.Primary activities include, but are not limited to:Reports to Executive Director or Associate Vice President, Therapeutic Area Lead.Develops worldwide… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …- Responsible, with limited supervision, for study activities assigned, eg for a clinical study : provide input on the development of study protocol ... The position will act as main statistical contact for the assigned studies , in particular in cross-functional Study team(s).Responsibilities- Study … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …relevant regulatory requirements. This position has experience working on Phase I-IV study studies within the medical device and/or pharmaceutical industry ... according to applicable Daiichi Sankyo and regulatory requirements.Functional Expertise:Reviews/approves clinical study related documents that are owned by… more
- Merck & Co. (Rahway, NJ)
- …and procedures and-with quality standards internally and externally.Under the oversight of the CRD( Clinical Research Director ) / Director , Clinical ... role will work across the different country operations roles (eg CRM( Clinical Research Manager), CRA( Clinical Research Associate )-Manager,-Partners, TA-Head,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the ... end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... disabilities.SummaryThis position supports early phase oncology development and leads complex studies in study design, statistical analysis and interpretation of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, ... or independently leads the design, preparation and analysis of epidemiologic studies , including real-word evidence (RWE), supporting senior management in various… more
- Merck & Co. (Rahway, NJ)
- …responsibility.The Associate Specialist -Operations Support position will report to the Associate Director , Engineering and will be a member of the EF ... Job Description Position Description: Associate Specialist - Operations Support The Enabling Facilities...scientists who are manufacturing drug substance to enable early clinical studies , scaling up new chemistries, and… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director Immuno-Oncology as part of the Research and Development team ... cell-based therapies. We are seeking an experienced and dynamic Associate Director to lead our in vivo...to drive the successful translation of preclinical findings into clinical applications. Your expertise will be critical in advancing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …vendor selection criteria.- Problem solves and negotiates in most service types, studies , and programs- Responsible for the development and management of other ad ... preferred Experience- 7 or More Years Outsourcing, health sciences or related field ( clinical trials) required- 7 or More Years Deep experience in pharma procurement… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …guiding other internal programmer or by self, perform programmatic review of Study Date Tabulation Model (SDTM) and analysis (including Analysis Data Model (ADaM)) ... ensure analysis dataset in compliance with CDISC and submission requirement, review study submission data package and ensure its quality and integrity.- Provide… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Value Access & Pricing will both develop ... for the assigned oncology asset(s). This person will report to the Sr Director , Global Oncology Value Pricing & Access, and will be responsible for providing… more
