- 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
- Merck & Co. (Rahway, NJ)
- …Solid Dosage (OSD) and Sterile operations, the RY119 Development Center, and Global Clinical Supply (GCS) Packaging within the scope of Our Company's Research Labs ... facility (inclusive of RY119) supports the formulation and filling of clinical , stability, and developmental Sterile, OSD and Inhalation supplies. These facilities… 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
- 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …understanding of engineering fundamentals. The Process Supervisor position will report to the Associate Director , MACS Operations and will be a member of the ... (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. The… more
- Bristol Myers Squibb (Berkeley Heights, 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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …studies and ensures scientific integrity and interpretation of study data of a clinical development program. The Associate Director leads in a matrix ... to join our Clinical Development team. The Associate Director Clinical Sciences leads... clinical safety + Promotes consistent first line medical/ clinical data review techniques and conventions across… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …therapeutic area preferred, along with relevant industry experience. A minium of 2-3yr ( Associate Director ), 4-8yr ( Director ) prior industry experience or ... The Associate Medical Director works with their...author protocols and facilitate execution of study activities and data summarization. Takes lead on collaborations with discovery scientists… more
- Bristol Myers Squibb (Summit, 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
- Touro University (New York, NY)
- …effective July 1, 2023 (pending budget approval). The Program Director and Associate Professor the master's program in Clinical Mental Health Counseling is ... Overview MS in Clinical Mental Health Counseling program at Touro University...Sciences invites applications for a full-time position as Program Director and Associate (or higher) Professor. Position… more
- System One (Basking Ridge, NJ)
- Associate Director , Clinical Safety...Health Authority inquiries on safety issues and prepares safety data for safety review boards. + Present safety ... plus + international MD is okay + 1-3 years of Pharmacovigilance (PV)/ clinical safety experience in pharmaceutical drugs either from relevant work experience within… 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 ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...+ Study Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC,… more
- Mount Sinai Health System (New York, NY)
- …team, a research clinical data warehouse team and a research data services team. The Associate Director , High Performance Computational and ... along with a focus on world-class customer service. The Associate Director is a productive partner for...file system,40+ petabyte archival storage system, and a research clinical data warehouse with a high availability… more
