- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… 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
- 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
- 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
- Bristol Myers Squibb (Princeton, NJ)
- …to accelerate modeling efforts in high-priority disease areas * Integrate preclinical and clinical data to inform model development and refinement * Coordinate ... $160,000-$190,000, plus incentive cash and stock opportunities (based on eligibility). + For Associate Director level, the starting compensation for this job is… 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
- 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
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …Management Lead will provide leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for ... assigned program(s). The PDML is a member of the Clinical Data Management extended leadership team, and...recruitment, development, coaching, mentoring, and performance management. **As an Associate Director , CDM Lead, a typical day… more
- J&J Family of Companies (Titusville, NJ)
- …of the way. Learn more at https://www.jnj.com/innovative-medicine Johnson & Johnson is seeking an Associate Director , Data Science & Digital Health to lead ... the development of data -driven digital products that accelerate and streamline clinical trial operations. This role will focus on designing and scaling tools… 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. (Princeton, 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
- 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
- Humana (Trenton, NJ)
- …caring community and help us put health first** The Utilization Management (UM) Director , Clinical Strategy and Practice for Medicaid builds strategies for ... engagement, best clinical practices and processes for clinical community within the enterprise. The Director ,...strategy support. This position will report directly to the Associate Vice President of Clinical Strategy and… more
- Merck (Trenton, NJ)
- …component of decision-making at our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas. This ... Associate Director will work with scientists within...models, exposure response (ER) models, model-based meta analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into… more
