- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** Job Description ** Associate Director , Clinical Pharmacology - Oncology** **_*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
- Takeda Pharmaceuticals (Trenton, NJ)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Patient Safety Clinical Operations in Cambridge, ... PV Activities globally, including set up and conduct of clinical studies from a PV perspective. You...the Pharmacovigilance Operations team, you will report to the Director , PV Clinical Operations and will be… 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 (Princeton, 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
- 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
- Bristol Myers Squibb (Princeton, NJ)
- …and success of the BMS R&D pipeline. This role reports to the Director , Clinical Data Management or Associate Director , Clinical Data Management ... is responsible for: **Project Management and Leadership** + Provides clinical data management leadership within the study ...Provides clinical data management leadership within the study team to align on and drive data collection… more
- Penn Medicine (Plainsboro, NJ)
- …budgets, patient visits, transporting specimens, data entry, query resolution, and working with study monitors. The Associate Director will also work closely ... clinical research proposals for their team. The Associate Director will work with Investigators and...and ongoing protocol training/compliance meetings. The Associate Director will assist in the development/maintenance of study… more
- Merck (Rahway, NJ)
- **Job Description** The **Senior Clinical Director (Sr. Principal Scientist)** has primary responsibility for the strategic planning and directing clinical ... Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle...safety and efficacy as well as new drug applications, clinical study reports, or publication; and +… more
- Merck (Trenton, NJ)
- …trials and/or investigator-sponsored research studies . The Regional Medical Scientific Associate Director serves as a role model for other field ... **Job Description** The Regional Medical Scientific Associate Director is a credentialed (ie, PhD, PharmD, DNP, MD) therapeutic and disease expert who engages in… more
- Novo Nordisk (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Research Partnerships (RP) is responsible for developing and executing ... alignment with the Evidence Generation Plan (EGP). Externally, the Associate Director RP will be the lead...and procedures. Relationships This position reports to a Senior Director within the Clinical Data Science &… more
- Merck (Trenton, NJ)
- **Job Description** The Regional Medical Scientific Associate Director is a credentialed (ie, PhD, PharmD, DNP, MD) therapeutic and disease expert who engages in ... questions from investigators and provides information regarding participation in Company-sponsored clinical studies Scientific Congress Support: + Engages in… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …transformation templates for reuse for study level configuration tasks. The Associate Director Data Configuration Engineer (DCE) oversees a team that ... and empower you to shine? Join us as an Associate Director , Data Configuration Engineer in our...bold mission. **OBJECTIVES:** Key to Takeda's success is the Clinical Data Engineering team, provides strategic planning, integrating, execution,… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Outcomes Research & Real World Evidence Princeton, NJ, USA Req #389 Wednesday, September 4, 2024 Looking for a chance to make a meaningful ... Employee Value Proposition: Join our growing Medical Affair team in the role of Associate Director , Outcomes Research & RWE. Your expertise will play a pivotal… 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 ... 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)
- …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
- Takeda Pharmaceuticals (Trenton, NJ)
- …innovation-driven company to inspire you and empower you to shine? Join us as an Associate Director , GCP Compliance based remotely reporting to the Director , ... research organization, including 6 or more years in compliance or clinical study management required. + Global/international experience required, including… more
- Sumitomo Pharma (Trenton, NJ)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs** . The Associate Director ... relationship with colleagues, fostering collaboration, and idea sharing + Reviews nonclinical, clinical and CMC documentation (eg nonclinical study reports, … more
- Bristol Myers Squibb (Princeton, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Purpose** The Associate Director , Biostatistics is a core member of cross-functional ... trial design, analysis planning, study results presentation and interpretation, clinical study report authoring, regulatory submissions and publications. +… more