- AbbVie (Branchburg, NJ)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , Clinical Development will have global or ... studies and ensures scientific integrity and interpretation of study data of a clinical development program....based in Branchburg, NJ or Irvine, CA. Responsibilities: The Associate Director will be responsible and accountable… 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
- Bristol Myers Squibb (Summit, NJ)
- …and at governance meetings based on proficiency + **Provide input** to Phase 2/3 clinical study design and registrational strategy + **Accountable for the** ... Clinical Pharmacology Plan + **Lead** design of clinical pharmacology studies and manages data analysis,...in related field (MS, Ph.D. or PharmD) + For Associate Director level with Ph.D. approximately 5+… more
- Merck (Rahway, NJ)
- **Job Description** **Job Overview:** We are seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in ... supporting the pharm and vaccine veterinary clinical trials. The ideal candidate will be responsible for overseeing the development and maintenance of clinical … 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
- Merck (Rahway, NJ)
- …operational plans for all clinical supply activities associated with the clinical studies in their assigned compound(s)/ program(s). The incumbent must have ... **Job Description** The Global Clinical Supply organization is accountable for managing the...ensures proper allocation of drug product as needed across studies within assigned program(s). + Responsible for identifying significant… more
- Merck (Rahway, NJ)
- …the way we approach serious diseases. The Director will report to an Associate Vice President in the Oncology Clinical Research Group. Under the guidance of ... Director will manage the entire cycle of clinical development, including study design, placement, monitoring,...of Clinical Scientists in the execution of clinical studies . + Work closely with a… 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
- 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 results… 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 ... studies including study design, protocol development, CRF review, SAP development, analysis...review. Acts as main statistical contact for the assigned studies and projects. Provides guidance to study … 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
- 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
- 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
- AbbVie (Florham Park, NJ)
- …level will be determined by the qualifications listed below. Purpose The Associate Scientific Director provides medical and scientific strategic and operational ... practice standards, including regulatory guidelines to meet customer needs. Qualifications Associate Scientific Director Qualifications + Bachelor's Degree in… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and unique opportunity for a medical writer to join our dynamic team at the Associate Director level. You will author a wide range of regulatory documents ... a wide variety of documents of all types and complexities, such as clinical study reports (CSRs) (all phases), investigator's brochures, CTD summaries/overviews,… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Associate Director Statistical Programming manages the statistical programming group within the therapeutic area(s). The incumbent oversees all activities, ... service providers, related to statistical and non-statistical analysis on clinical program(s). The incumbent identifies and communicate therapeutic specific… more
- Bristol Myers Squibb (Summit, NJ)
- …no better place than here at BMS with our Cell Therapy team. The Associate Director , Drug Product External Manufacturing QA provides Quality oversight to ... Deviations, CAPAs, Change Controls, Batch Record Review, Lot disposition to support the clinical and commercial release of Drug Product. This role will also develop… more