- 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 ... operations to assess operational performance. Relationships Reports to the Director , Pharmacy Ops. Key internal relationships include brand marketing, market… 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. Summary: The Associate Director , Laboratory Data Management is accountable for the ... Lab Technology (MLACS-accredited), or NAACLS-accredited preferred Experience Qualifications - Clinical data management laboratory experience and strong knowledge… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …implementation of a CDx study/IVDR performance evaluation study integration of an assay into clinical testing (before testing) and once data is ready for CDx ... between CTA/CDx assays, prospective vs retrospective analyses and collection, missing data , demographic/representativeness of samples from clinical trial and… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/ Associate Director , has primary responsibility for ... Care Pharmacy (AMCP) dossiers for US payers, and Global Value DossiersDevelops supplementary clinical data package in close partnership with markets and HTA… more
- Daiichi Sankyo, Inc. (Bernards, 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …cross-functionally to ensure successful implementation of the CDx and associated data collection. Oversees clinical trial sample testing activities and ... the Dx partner for CDx project contracts. Supports CDx analytical and clinical validation studies in collaboration with Dx-partner Provides scientific and technical… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is accountable ... QA RDPVQA, and oversees multiple levels of direct reports (Directors, Associate Directors, Managers, contractors as applicable) across the Global Quality teams… more
- Bristol Myers Squibb (Princeton, NJ)
- …. This position will be based in San Diego, CA or Lawrenceville, NJ. **Summary:** The Associate Director , Clinical Data Management, will play a crucial ... our data management efforts, ensuring the accuracy, consistency, and integrity of clinical data . This position involves leading and overseeing all aspects of… 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
- Sumitomo Pharma (Trenton, NJ)
- …are currently seeking a versatile and experienced Senior Manager - Associate Director level scientist with strengths in clinical pharmacology, and a working ... of drug metabolism and bioanalytic chemistry. This position will report to Senior Director of Clinical Pharmacology and Drug Metabolism. S/he will work across… 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
- Merck (West Point, PA)
- …Business, Business Risks, Change Management, Clinical Development, Clinical Research, Cross-Functional Team Leadership, Data Analysis, Detail-Oriented, ... **Job Description** The Global Clinical Supply (GCS) organization is accountable for managing...business risks, & influence portfolio decisions with facts and data Demonstrates ability to balance strategy with ability for tactical… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. **Summary:** The Associate Director , Laboratory Data Management is accountable for ... Lab Technology (MLACS-accredited), or NAACLS-accredited preferred **Experience Qualifications** - Clinical data management laboratory experience and strong… more
- Merck (West Point, PA)
- **Job Description** We are seeking a highly skilled and motivated Associate Principal Scientist/ Associate Director with expertise in conducting outcome ... analysis models to extract meaningful insights and outcome research evidence. **Unstructured Clinical Data :** + Utilize transfer learning, fine tuning, GAN,… more
- Bristol Myers Squibb (Princeton, NJ)
- …. **Position Summary** + This role is responsible for managing data flows across multiple external vendors and enabling reports from that ... data to ensure that biospecimens are tracked along the...and referral laboratory vendors) **Reporting Relationship** + Manager - Director , Specimen Library, Systems & Logistics **Qualifications** + Minimum… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …academic translational clinical research experience (as a general guideline, 1-3 years for Associate Director level; 3-6 years for Director and 6-9 years ... While not essential, prior personnel management experience, will support position at entry ( Associate Director / Director ). + An advanced understanding of drug… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …translational clinical research experience (as a general guideline, 1-3 years for Associate Director level; 3-6 years for Director is typically required ... While not essential, prior personnel management experience, will support position at entry ( Associate Director / Director ). + An advanced understanding of drug… more
- IQVIA (New York, NY)
- **MSL Associate Director ** We are excited to announce that currently we are looking for **Medical Science Liaison Associate Director and Player-Coach** ... inform decision making on various aligned teams. The **MSL Associate Director & Player Coach** will have...about the current competitive landscape. + Upon request, presents clinical data to healthcare professionals (scientific peer… more
