- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving ... where appropriate and escalate any complex problems to the Director , Clinical Study Startup.This position... protocols to ensure consistency in safety requirements across studies related to a similar compound. Develops and oversees… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL) Study Planning and Execution: Provides ... 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)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... centered around rare diseases and immune disorders. Summary Position leads complex studies in study design, statistical analysis and interpretation of results… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …also contribute to strategic planning and provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing ... centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a... regulatory documents include, but are not limited to, clinical study reports, investigator brochures, regulatory briefing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and timelines for assigned studies and escalates issues to the Associate Director of Medical Coding to gain resolution. Functional Expertise: Study ... coding services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure...DS Medical Coding synonym list update requests to the Associate Director of Medical Coding to ensure… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- … and ensures scientific integrity and interpretation of study data of a clinical development program. The Associate Director leads in a matrix ... clinical studies and programs. As an Associate Director a typical day may include...in collaborative activities with other departments; Member of the Clinical Study Team and Global Clinical… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** ** Associate Director , Clinical Pharmacology - Virology** **_*This is ... and study sites to implement and monitor clinical pharmacology studies . Addresses clinical ...regulations, ICH guidelines, and GCP governing the conduct of clinical studies . Has significant knowledge of pharmaceutical… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** This position works with the Director , Clinical Study Startup to establish the strategy driving ... where appropriate and escalate any complex problems to the Director , Clinical Study Startup. This... protocols to ensure consistency in safety requirements across studies related to a similar compound. Develops and oversees… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …key metrics and Key Performance Indicators (KPIs) across studies and within clinical program(s) to track study progress. + Manages all aspects of Quality ... quality, timelines and resources related to the conduct of clinical research studies in accordance with applicable...with senior level management, external vendors, collaboration partners and clinical study personnel for clinical … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Develops biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL) + Study Planning and Execution: ... Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. **Responsibilities** + Study Strategy:… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …City, CA. This is NOT a remote position **RESPONSIBILITIES:** + In partnership with Clinical Program Manager or Associate Director , provides guidance and ... Plan, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans, Clinical Study Report + Coordinates data review to support… more
- Bristol Myers Squibb (Summit, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . Position Summary The Associate Director , RBQM - HOCT, ICN will mainly be responsible ... and issue management. Provide quality and compliance consultation to clinical trials teams throughout study lifecycle and...compliance consultation to clinical trials teams throughout study lifecycle and establish a feedback loop to ensure… more
- Bayer (Whippany, NJ)
- …biopharmaceutical industry, clinical and/or academic work experience; + Understanding of clinical study design, analysis and interpretation as well as the ... to make a real difference, there's only one choice.** ** Associate Medical Director , US Medical Affairs Oncology,...principles of observational studies and health economics/ outcomes research; + Proven record… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... centered around rare diseases and immune disorders. **Summary** Position leads complex studies in study design, statistical analysis and interpretation of… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …also contribute to strategic planning and provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing ... centered around rare diseases and immune disorders. **Summary** The Associate Director of Regulatory Writing is a... regulatory documents include, but are not limited to, clinical study reports, investigator brochures, regulatory briefing… more
- Bristol Myers Squibb (Summit, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Associate Director , Therapeutic Area Audit Strategy Lead will be ... protocols using data and information from discovery phase, non- clinical and clinical studies +...that GxP follow-up CAPA activities are completed + Oversee study centers, countries, investigators and connect with PV, Medical… more
- AbbVie (Florham Park, NJ)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose: The Associate Director in CMC Statistics is responsible for providing statistical ... is determined by years of experience, education, and relevant experience. Qualifications for Associate Director , Statistics (CMC): + MS (with 10+ years of… more
- Actalent (Bridgewater, NJ)
- …Statistical Analysis Plans (SAPs), Statistical Reports, and statistical methodologies sections of Clinical Study Reports (CSRs). Perform peer review of SAPs and ... Job Description Work with a Director , Senior Director , and/or Executive ... of Biostatistics, Statistical Operations, or Biometrics to manage clinical trial programs/projects from one or multiple clients. Provide… more
- Bristol Myers Squibb (Berkeley Heights, NJ)
- …every treatment we pioneer. Join us and make a difference. **Purpose** The Associate Director , Biostatistics is a core member of cross-functional development ... trial design, analysis planning, study results presentation and interpretation, clinical study report authoring, regulatory submissions and publications. +… more
- Sanofi Group (Bridgewater, NJ)
- …Join our **Biostatistics Immunology & Inflammation as Statistical Project Leader ( Associate Director )** and you'll provide statistical leadership and guidance ... Responsibilities:** + Expert level of statistical and scientific contribution to clinical development plans, studies and submissions activities (when… more
