- 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
- 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)
- …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
- 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
- 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)
- …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
- Bristol Myers Squibb (Berkeley Heights, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Associate Director , Clinical Data Standards is a leadership role with ... Director , Head Standards Management & Steward within Clinical & Safety Data Insights and Analytics....a broad portfolio and effectively express his/her views to senior management. + Representing the Company in interactions with… more
- AbbVie (Florham Park, NJ)
- …clinical trial. Our operational model is exemplified through execution and innovation. The Director of Clinical Data Strategy & Operations (CDSO) oversees ... Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Abbvie Clinical Data Strategy and Operations (CDSO) is...is commensurate upon experience. There are 2 job openings: Director , Data Management Operations (Solid Tumor), … more
- Bristol Myers Squibb (Summit, NJ)
- …and pharmacometric support for all pipeline assets throughout the clinical development lifecycle. Composed of pharmacologists, pharmacometricians, data ... for the** Clinical Pharmacology Plan + **Lead** design of clinical pharmacology studies and manages data analysis, interpretation, and reporting… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Senior Medical Director , Clinical Sciences, Hematology provides clinical leadership and is responsible for all clinical deliverables within the ... a clinical program with minimal supervision from Program Lead MD. Clinical deliverables may include individual protocols consistent with the Clinical … more
- Bristol Myers Squibb (Summit, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . **Title: Sr . Manager / Associate Director , Global Sterility Assurance CTTO** ... at BMS with our Cell Therapy team. T he ** Sr Manager/Associate Director - Sterility Assurance, Cell...hold studies, disinfectant efficacy + Uses trend and scientific data to drive risk-based decisions. + Drive innovation in… more
- Bristol Myers Squibb (Summit, NJ)
- …Join us and make a difference. **Summary/Scope** Reporting to Senior Scientific Director Translational Medicine, the TM Sr . Principal Scientist will be part ... and validation partnering with Translational Sciences colleagues when applicable + Manages clinical biomarker data delivery and analysis and associated timelines… more
- Danaher Corporation (New York, NY)
- The Senior Director of Portfolio and Programs for Leica Biosystems is a senior thought leader in the Advanced Staining Reagents (ASR) and Pharma Partnerships ... You will also be pivotal in leading and supporting clinical Artificial Intelligence (AI) and clinical technology...technology strategy (ie, computational pathology, spatial, etc.). As the Senior Director , you will be developing and… more
