- Merck & Co. (Rahway, NJ)
- … members. - May interact with internal and external stakeholders (eg, study team , vendors, committees) in support of clinical trial objectives. You will be ... for a single study or across multiple studies (eg, operational deliverables, clinical & ancillary...project assignments under the direction of Lead Clinical Scientist and Lead Study … more
- Merck & Co. (Rahway, NJ)
- …and execution of one or more clinical trials. You will assist the Lead Clinical Scientist and study team with the scientific conduct of clinical ... for specific clinical /scientific activities on a single study or across multiple studies (eg, medical...project assignments under the direction of Lead Clinical Scientist and Lead Study … more
- Merck & Co. (Rahway, NJ)
- …and Clinical Directors responsible for the design and medical monitoring of clinical studies .Ensure optimal design and monitoring of clinical programs ... Job DescriptionAs a key member of the General Medicine Global Clinical Development team , the Vice President/ Therapeutic Area (TA) Head's primary objectives will… more
- Merck & Co. (Rahway, NJ)
- …including those new to the organization therefore requiring someone who has built and lead clinical development plans from the ground up. They will also be ... responsible for guiding Product Development Team Leaders and Clinical Directors within their...projects, including pipeline candidates and licensed productsSupervises development of clinical documents including protocols, clinical study… more
- Merck & Co. (Rahway, NJ)
- …to end Data Management activities with the support and oversight of a Senior Clinical Data Manager (SCDM)/ Lead Clinical Data Manager (LCDM); issuing queries ... study sites, vendors, committees, etc.) in support of clinical study objectives.--You will be part of... objectives.--You will be part of a diverse, cross-functional team of individuals who execute our clinical … more
- Merck & Co. (Rahway, NJ)
- …into a functional drug product optimized for patients and for ensuring the availability of clinical supplies for patients. Within the PSCS team is the Global ... sessions, and receive direction from our Veteran Talent Program Lead throughout the Fellowship. Our primary objective is to...or run by partners, and 300+ company Investigator Initiated Studies (IIS) clinical trials. GCS is accountable… more
- Merck & Co. (Rahway, NJ)
- …submissions.Represent QP2 on discovery, early clinical development and late clinical development teamsWork closely with pharmacometrics team members and ... collaboration, and problem scoping and planningDemonstrated ability to participate in and to lead an interdisciplinary team , and to oversee the work of other… more
- Merck & Co. (Rahway, NJ)
- …training in cardiovascularSignificant research experience as lead clinical investigator, specifically experience with investigator-initiated studies , concept ... Job DescriptionOur Medical Affairs team advances medical science and patient care by...(EDSA) maximizes meaningful bi-directional scientific exchange with the worldwide clinical and academic community to positively impact Research and… more
- Merck & Co. (Rahway, NJ)
- …our potential medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific knowledge, statistical analysis and ... drugs and vaccines for the benefit of patients and global human health.Our Quantitative Sciences team uses big data to analyze the safety and efficacy claims of… more
- Merck & Co. (Rahway, NJ)
- …authoring for regulatory documents such as Investigational New Drug application, Clinical Study Report, Common Technical Document, and agency- interactions.-You ... and Pharmacometrics --Immune/Oncology-(QP2-IO)- team in the role of-Senior Specialist.--QP2-IO team is part of the Global Clinical Development organization… more
- Merck & Co. (Rahway, NJ)
- …Ultimately, this position is expected to work cooperatively with the SSO leadership team and SSO partners to drive overall success and performance of the building, ... SM PR&D pipeline. Responsibilities: Under the scientific direction of a facility lead , the Operations Specialist will participate in equipment setups, raw material… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or project; Attends EOP2 meeting and represents clinical /TMCPStudy Planning and Execution: Clinical Study Lead (CSL) for large Phase 3 registrational ... biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team ...Present results to regulatory agencies during pre-submission meetings; Interpret study results in context of other studies … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …resolve, propose solutions, or bring to the attention of the operations lead of study team lead . Coordinate and liaise with Daiichi Sankyo QA on site ... and quality deliverables. Lead the development of the clinical study plan including critical path activities...CRO and vendor selection process in collaboration with the study team and outsourcing procurement management. Lead… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of the Global Project Team (GPT), the incumbent closely collaborates with the Global Clinical Lead (GCL), the Global Team Leader (GTL), and other members ... Science Strategy and delivery of clinical studies for one or several oncology assets:- Lead...to end in collaboration with Physician Scientists and the study team (data management, clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies , conduct hands on population PK and PKPD analyses and ... all aspects of clinical pharmacology and biopharmaceutics studies ; clinical pharmacology project lead ;...interactions at project level, interacts with regional and global study and project team members, and to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …profile throughout product lifecycle Independently leads activities without supervision for assigned clinical studies Lead activities under the direction of ... clinical studies in partnership with Clinical Safety Scientist Product Lead , Product Safety... studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and review Statistical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Clinical Development in Project Teams, possibly as Global Clinical Lead . ResponsibilitiesStudy Strategy: Clinical study leader (CSL) or major ... updates; Responsible for valid clinical interpretation of study results as Clinical Study ...KOLs or major institution, eg NCI.Scientific, Program related: Integrated Study Team (IST) representative: Creates early development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … operations, responsible for representing the GCO-CQM inspection readiness within the Clinical Team , the inspection preparation team , and transversal ... areas centered around rare diseases and immune disorders. Summary The Manager, Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is responsible… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …developing the Global Clinical Science Strategy and delivery of clinical studies in late stage development. Lead and manage the multiple late development ... (Oncology) Clinical Science resources are deployed to clinical studies from end to end in...end in collaboration with GCLs, Physician Scientists and the study team (data management, clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …cultural sensitivity and health literacy guidelines are followed.Establish tracking mechanisms at the study team and clinical trial site level to proactively ... plans 4) people manage in future. Responsible for the successful delivery of study diversity plans in adherence with Good Clinical Practices (GCPs), appropriate… more
