- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and associated documents (writing of ICF, DM charter, response assessment charter, etc), clinical data review excellence with a focus on patient safety and ... Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical...of high-quality clinical trial protocols, review of clinical data and Clinical Study… more
- Merck & Co. (Rahway, NJ)
- …clinical data /medical protocol deviations in collaboration with the Clinical Director .Builds talent and capabilities of direcUindirect team members ... and prioritization skillsAdvanced analytical skills with the ability to interpret clinical trial data and synthesize conclusionsInteract with key stakeholders… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …TMCP to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... plan by function and team; Interprets and react accordingly to new preclinical/ clinical data (eg; Go/No Go decisions, reprioritization, etc.); Operational Project… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …TMCP to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... plan by function and team; Interprets and react accordingly to new preclinical/ clinical data (eg; Go/No Go decisions, reprioritization, etc.); Operational Project… more
- Merck & Co. (Rahway, NJ)
- …Point, PA / Rahway, NJ is seeking a curious and collaborative Director to support our rapidly expanding cardiology respiratory, metabolism and ophthalmology ... pipeline.As a Director , you will serve as an expert QP2 representative...teams of experienced scientists to discover and advance the clinical development of novel therapeutic agents for cardiac, respiratory,… more
- Eisai, Inc (Nutley, NJ)
- …and make a difference. If this is your profile, we want to hear from you. Director , Global RWE & Data Science sought by a pharmaceutical company in Nutley, ... NJ. Assess real-world data gaps and lead evidence generation process for the...clinical practice.Requirements:Master's degree (or foreign equivalent) in Statistics, Data Science or Risk Management and Insurance or related… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review PlanAccountable for ... Organization (CRO) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility and medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review- Conducts clinical data review per Integrated Data Review Plan- Accountable ... centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development,...Monitor (MM):- Provides oversight to the CRO MM for clinical data review activities- May support addressing… more
- Merck & Co. (Rahway, NJ)
- …provides a high degree of technical and project management responsibility. The Associate Director - Process/Facility Lead position will report to the Director , ... Responsibilities include the following:The process/facility lead role at the Associate Director level will serve as a technical mentor and operations team… more
- Merck & Co. (Rahway, NJ)
- …approach, driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …stakeholders including members of Global Companion Diagnostics, Translational Sciences, Global Clinical Operations, Biostats and Data Management and Clinical ... and leads clinical trial sample testing activities and data capture to support CDx regulatory submission or associated drug regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: The Associate Director of Regulatory Writing is a key role responsible for producing scientifically ... accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. This...strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of… more
- Merck & Co. (Rahway, NJ)
- …the role of Director . QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to clinical ... of the strategic elements of drug development. As a subject matter expert, the Director within the QP2-IO Group will work closely with teams of highly collaborative,… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of robust compositions,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to… more
- Merck & Co. (Upper Gwynedd, PA)
- …medical affairs lens), and recommending required medical affairs resources.Support integrated data generation plans and co-develop clinical and outcomes research ... Job DescriptionThe Global Director Medical Affairs (GDMA) Oncology Assets & Pipeline...labeling committees. Ensure labels contain fair-balanced claims supported by data and supportive of asset-related medical, clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary Director , Global Medical Affairs Oncology Publications works with Cross Functional Team ... company, including authors, researchers, investigators, GMA medical leads, R&D clinical leads, bio stats and Publications Committee members on publication… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the ... Senior Director , GMA Oncology ADC (Global Medical Affairs team lead...information and internal education, publications, scientific exchange and external data communication, and stakeholder scientific engagement. Responsible for managing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The PositionThe Novo Nordisk Real World Evidence (RWE) / Clinical Data Science & Evidence (CDSE) - Fellow is responsible for supporting ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
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