- Novo Nordisk Inc. (Plainsboro, NJ)
- …and execution of National Advisory Board meetings, at the discretion of Executive Director ) Deliver clinical data and other presentations at National ... for select clinical trials, in collaboration with Clinical Director and Clinical Operations...gain feedback from advisors Support other advisory boards with clinical data and other medical presentations Partner… 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
- Sun Pharmaceutical Industries, Inc. (Blawenburg, NJ)
- Job Title: Head of Clinical Data Management Job Grade: G6/G7 Department: Biostatistics and Data Management FLSA Classification: Manager's Job Title: Head of ... Main responsibilities will include effective leadership, planning and oversight within the Clinical Data Management (CDM) function as well as facilitating… 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 (IDRP)- ... (CRO) Medical Monitor (MM):- Provides oversight to the CRO MM for clinical data review activities- May support addressing eligibility and medical questions from… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for assigned compound under the supervision and leadership of the Executive Director of Medical Research and Strategy, US Oncology Medical Affairs (USOMA). Develops ... function as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, US and Global Brand Team, and US Product… more
- Tris Pharma (Monmouth Junction, NJ)
- …deliver information on our products to Healthcare Professionals.The Senior Director / Director , National Sales ( Sr NSD) provides leadership, direction ... product launch. We have a position available for a Senior Director / Director , National Sales (NSD)...team working together to generate sales, communicate and promote clinical and economic benefits of the product(s), build and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary Sr . Director Data Management contributes to the vision, direction ... management, coaching and development of team members.Acts as a Data Management point of contact for Senior ...and biostatisticsKnowledge of industry standards and best practices in clinical data management and relevant Good … more
- 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. SummaryThe 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)
- …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
- 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 ... for the assigned GMA plan activities, in collaboration with Sr Director .Leads medical readiness activities for market...and other scientific exchange activities in alignment with the Senior Director , such as scientific symposium and… more
- Merck & Co. (Rahway, NJ)
- …position available at our company's research facility. The Principal Scientist is a senior scientific role tasked with working closely with the group Director ... understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications.Ability to design, execute… 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
- 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
- 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...& budget management. RelationshipsThe fellow will report to the Senior Director RWE during the program and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … development and regulatory requirements of a clinical program. Relationships The Senior Medical Writer reports to a Director of Medical Writing. The ... personnel from Medical & Science, Clinical Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs, Global Safety, Data Management, and… 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. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... and report on the effectiveness of implemented strategies, making data -driven recommendations for continuous improvement Continued Improvement: Cultivate a strong… more
