- Eisai, Inc (Nutley, NJ)
- …research is required.#LI-MI1#IND123#LI-RemoteEisai Salary Transparency Language:The base salary range for the Associate Director , Clinical Data Science - ... difference. If this is your profile, we want to hear from you. The Clinical Data Science team at Eisai, Inc., is expanding its capabilities by acquiring in-house… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and management of the resources within NACD. Relationships Reports to Snr Director of Clinical Strategy and Business Operations within Operational Excellence ... 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
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, NJ)
- …an equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for ... industry standard data collection practices preferred- 7+ years Clinical data management experience in a medical device, pharmaceutical company, or similar… more
- Merck & Co. (Rahway, NJ)
- …of decision-making at ouor company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This ... Associate Director will work with scientists within QP2 by applying...models, exposure response (ER) models, model-based meta analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into… more
- Merck & Co. (North Wales, PA)
- … Director , Pulmonary Arterial Hypertension (PAH) Payer Marketing & Access Strategy As Associate Director , PAH & Rare Disease Payer Marketing, you will be an ... gaps and evidence needs.Consider the impact of potential new clinical data and competitor developments on US access environment and strategy.Analyze relevant… 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...information and internal education, publications, scientific exchange and external data communication, and stakeholder scientific engagement. Responsible for managing… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOverview:The Associate Director Publication (Pub) Manager is the central source of information regarding publication activities and is responsible ... development and implementation of global publication strategies and tactical plans. The Associate Director Pub Manager oversees compliance with our company's… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director , Quantitative Systems Pharmacology (QSP) will work within the ... Quantitative Clinical Pharmacology (QCP) group to develop and apply QSP...virtual population workflow is desirableExperience with general programming and data analysis tools/languages such as Python or R would… 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 Assoc Director OED - Supplies, is responsible for US and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary Position manages the end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other ... development processes and global submissions. This position provides leadership within Data Management by partnering with internal and external stakeholders to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
- Merck & Co. (Rahway, NJ)
- …of, contractors performing various GMP activities supporting the production of clinical supplies with focus on drug product. Additionally, experience in medical ... metrics, conduct of contractor "deep dive" quality assessments such in data integrity and leading cross-functional contractor performance reviews as the quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …independently in order to accomplish objectives. Relationships Reports to the Director , Patient Support Programs Rare Disease. Key internal relationships include ... patient HUB patient support programs Develop performance dashboards and interpret hub data for purposes of assessing market access trends, hub program utilization,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …technology transfer, site-to-site technology transfers and PPQ as needed. Conduct data review and analysis, data -driven decision-making process, and support ... data transfer to the appropriate data repository - liaison between the Tech Strategy (...manufacturing sites.- Conduct scouting activities and recommend CDMOs for clinical and launch site selection from Tech Mgmt. (mAb,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, ... study findings through presentations and/or publications in peer-reviewed scientific journalsAssess clinical trial and/or other data sources to contextualize… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …training and ensure effective implementation of SDTM, ADaM and TLFs standard in clinical trial data analysis- Develop and maintain necessary programming macros ... review of Study Date Tabulation Model (SDTM) and analysis (including Analysis Data Model (ADaM)) datasets as well as TLFs generated by statistical vendor,… more
- Merck & Co. (Rahway, NJ)
- …pipeline products to produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director , is a ... for growth opportunitiesThe Vocabulary Specialist may lead or participate in:Internal clinical data standards forumsStandards development teams and data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data .-...with data manager to ensure high quality data .- Drug Development Strategy: Provides input to multiple aspects… more
- Merck & Co. (Rahway, NJ)
- …The FLEx Co-Lead role is based in New Jersey and reports to the Associate Vice President of Pharmaceutical Operations and Clinical Supply in our Research ... new digital capabilities that allow for better access to high-fidelity data , more efficient clinical product release, improved product/process characterization,… more
