- Novo Nordisk Inc. (Plainsboro, NJ)
- …for operational improvements and seek agreement through consensus management.RelationshipsReports to an Associate Director / Director within the NNI ... in one or more of the following is preferred: Market Research, Data & Analytics, Clinical OperationsPharmaceutical industry experience helpful, but not… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Coast Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Non- ... and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …other safety information for all Novo Nordisk products. Relationships Reports to Associate Director , Patient Safety Training. Internal relationships include all ... 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. (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)
- …other research areas 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...and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.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...and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Associate Director Immuno-Oncology as part of the Research and Development ... cell-based therapies. We are seeking an experienced and dynamic Associate Director to lead our in vivo...to drive the successful translation of preclinical findings into clinical applications. Your expertise will be critical in advancing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global sites. These business functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, ... Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical trials preferred- Demonstrated ability to leverage digital data and analytics preferred- Demonstrated ability driving or participating in digital ... procurement for Global RD - for their specific categories.- Data Analysis Based Decision-Making- Uses rigorous analyses of ...or More Years Outsourcing, health sciences or related field ( clinical trials) required- 7 or More Years Deep experience… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core ... Data Sheets (CCDS) for assigned products. This position drives/leads...all applicable regulations and guidelines and with Company Core Data Sheets and manages deviations. This position interacts across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory ... Liaisons to ensure successful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review of documents supporting… more
- Daiichi Sankyo, Inc. (Bernards, 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 .Drug...with data manager to ensure high quality data .Drug Development Strategy: Provides input to multiple aspects of… more
- Bristol Myers Squibb (Princeton, NJ)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Associate Director , Clinical Data Standards is a leadership ... Director , Head Standards Management & Steward within Clinical & Safety Data Insights and Analytics....Insights and Analytics. **Position Responsibilities** + Providing leadership of clinical data standards activities across multiple … more
- Bristol Myers Squibb (Princeton, NJ)
- …**Position Summary:** We are seeking a highly motivated and detail-oriented Associate Director - Product Manager with broad clinical data experience to ... join our IT team within the Clinical Data Ecosystem team. The successful candidate will play a critical role in supporting the development, implementation, and… more
- Bristol Myers Squibb (Princeton, NJ)
- …design, development and implementation of technical solutions for integrating, analyzing and reporting clinical data . Associate Director drives the ... development and implementation of innovative strategies and technologies for clinical trial programming. Associate Director ...medical terminology used in the analysis and submission of clinical data + Broad expertise in statistical… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …studies and ensures scientific integrity and interpretation of study data of a clinical development program. The Associate Director leads in a matrix ... join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads...and designs mitigation strategies + Promotes consistent first line medical/ clinical data review techniques and conventions across… more
- CenterWell (Trenton, NJ)
- …the ambassador for value-based, senior care model in the primary care network. The Associate Director , Clinical Coding Education (RN) will develop, design, ... a team of role-based trainers and training facilitators. The Associate Director , Clinical Coding Education...assess the effectiveness of clinician coding training; socialize training data with key clinical leaders + Supervise… more
- AbbVie (Branchburg, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director , Clinical Development will have global or ... Program Lead and Clinical Science Lead and Clinical Scientist. The Associate Director ,... content, including, but not limited to protocols, IBs/IDFUs, clinical data reviews, CSRs, regulatory submissions, and… more
- Bristol Myers Squibb (Princeton, NJ)
- …+ Advanced Degree in related field (MS, Ph.D. or PharmD) + For Associate Director level with Ph.D. approximately 5+ years experience with demonstrated ... and pharmacometric support for all pipeline assets throughout the clinical development lifecycle. Composed of pharmacologists, pharmacometricians, data … more
- Bristol Myers Squibb (Princeton, NJ)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Associate Director , Agile Sourcing - Clinical Services will be ... be focused on CROs, Patient & Site Facing Services, Clinical Technologies, Clinical FSP, and a host...comfortable with leading change and taking calculated risk. The Associate Director will lead a team of… more
