- 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
- 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
- Merck & Co. (Rahway, NJ)
- …Business, Business Risks, Change Management, Clinical Development, Clinical Research, Cross-Functional Team Leadership, Data Analysis, Detail-Oriented, ... Job DescriptionThe 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… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a highly skilled and motivated Associate Principal Scientist/ Associate Director with expertise in conducting outcome ... models to extract meaningful insights and outcome research evidence. Unstructured Clinical Data : Utilize transfer learning, fine tuning, GAN, transformer,… more
- Merck & Co. (Rahway, NJ)
- …of decision-making at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate ... on a continuous basis in decision making and driving pipeline impact. The Associate Director will perform job duties independently with minimal supervision… more
- Merck & Co. (Rahway, NJ)
- …the Quantitative Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with teams… more
- Merck & Co. (Rahway, NJ)
- 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
- Merck & Co. (Rahway, NJ)
- …Systems, Business, Capital Project Management, Change Management, Chemical Manufacturing, Clinical Manufacturing, Compliance Reviews, Data Analysis, Decision ... Job DescriptionAbout the Role:-As a Technical Lead, you will report into Director , Chemical Technical Operations, External Manufacturing API Technology, and play a… more
- Merck & Co. (Rahway, NJ)
- …West Point, PA / Rahway, NJ is seeking a curious and collaborative Associate Director to support our rapidly expanding cardiometabolic and ophthalmology ... pipelines. - As an Associate Director , you will represent QP2 on cr o ss- f uncti o nal te a ms of experienced sci e ntis ts to discover and advance the … more
- Eisai, Inc (New York, NY)
- …May provide training on GCP and current regulations for those undertaking clinical studies.Job SummaryThe Associate Director , GCP Quality Assurance ... Travel (approximately 25%)Eisai Salary Transparency Language:The base salary range for the Associate Director , Clinical Quality Assurance is from… more
- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you.The Associate Director supports the Eisai Global Oncology Business Unit for the Americas, ... and Senior Leaders to drive program plans and decision making Job Summary The Associate Director supports the Eisai Global Oncology Business Unit for the… more
- Merck & Co. (Rahway, NJ)
- …Administration, Business Administration, Business Support Services, Clinical Medicine, Collaboration Tools, Collaborative Communications, Communication, ... become reality.-This position is based in Rahway, NJ-Reporting to the Executive Director of General and Specialty Medicine in GPAM, the core responsibilities of… 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 ... operations to assess operational performance. Relationships Reports to the Director , Pharmacy Ops. Key internal relationships include brand marketing, market… 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 (Madison, 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
