- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science ... associated documents (writing of ICF, DM charter, response assessment charter, etc), clinical data review excellence with a focus on patient safety and data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated ... UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review- Conducts clinical data review per Integrated Data Review Plan- Accountable for the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated ... in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review PlanAccountable for… 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)
- …research areas centered around rare diseases and immune disorders. Job Summary:The Senior Director , Quantitative Systems Pharmacology (QSP) will work within the ... Quantitative Clinical Pharmacology (QCP) group to develop and apply QSP...required4 or More Years Experience with general programming and data analysis tools/languages such as Python or R would… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the Senior Translational Strategy Lead.Construct translational plan documents, biomarker data analysis plans, and aid in the construction of clinical ... enumerate key translational hypothesis that will drive scientific decision-making both from non- clinical and clinical translational aspects. In doing so, he or… more
- Eisai, Inc (Nutley, NJ)
- …is driven to use cutting edge modeling approaches to advance the clinical and translational research in Neuroscience. This individual will provide scientific ... across all phases of drug development. The complexity and scale of data being generated has grown significantly and requires strong scientific contributions to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to internal and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key ... within the US East Coast Development Hub comprised of Senior Global Safety Leads, Global Safety Leads and ...internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics,… more
- Merck & Co. (North Wales, PA)
- … data /medical protocol deviations in collaborations with the Clinical Director .Other responsibilities include: Collaborating cross-functionally in the ... in collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and integrity of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the Senior Director , GMA Oncology ADC (Global Medical Affairs team lead for ... medical education and other scientific exchange activities in alignment with the Senior Director , such as scientific symposium and medical congresses, within… more
- Merck & Co. (North Wales, PA)
- …and coordinating statistical activities supporting drug/vaccine projects.Interacts with Clinical , Regulatory, Statistical Programming, Data Management, and ... project management experiences are necessary.Solid knowledge of statistical analysis methodologies, clinical trial designs, and statistical and data processing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …group and high-complexity disease work to support critical strategic choices for the clinical program. The DAST Director will collaborate with the DAST Lead ... assessing competitive impact to the disease strategy and the strategic choices for clinical development and data generation- Develop and define DAST best… 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
- 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
- Merck & Co. (Rahway, NJ)
- …disclosure of clinical trials and their results, document disclosure, and data sharing with external researchers. The Executive Director in Medical Writing ... regulations and internal company policies.Responsible for managing all external requests for clinical data .- Periodic review of metrics and identification of… more
- Merck & Co. (South San Francisco, CA)
- Job DescriptionThe Director of Immuno-Metabolism will be responsible for overseeing and facilitating the research in metabolic disorders & inflammation, in the ... CMD strategy, including integration of new technology platforms, human biology, and data science, with a focus on uncovering novel biology in immuno-metabolism to… more
- Merck & Co. (North Wales, PA)
- …Associate Principal Scientist, Outcomes Research Under the guidance of a senior leader, an Associate Principal Scientist has primary responsibility for ... teams to effectively communicate outcomes research and health economic modelling data internally and to external stakeholders.Present outcomes research data … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director of Biologics Potency in Analytical Research & Development is responsible for providing strategic and technical leadership for a portion ... partnering to build a culture of innovation and inclusion.-The Director reports to the Executive Director , Cell...be directly responsible for a team of approximately 10-15 senior and associate level scientists in Rahway, New Jersey.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining ... Managed Markets, Legal, Compliance, and Finance. The position has high exposure to senior management and requires a highly motivated individual who is able to work… more
- Novo Nordisk Inc. (Atlanta, GA)
- …coordination with his/er Field Director . Relationships Position reports to Field Director / Senior Field Director . Serves as organization spokesperson on ... 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
