- 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... 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; andParticipation in… more
- Merck & Co. (Rahway, NJ)
- …of entire Clinical Teams in the execution of clinical studies .--Will report and work collaboratively with the- Associate Vice President to promote ... Job DescriptionOur Clinical Development teams manage studies to...safety and efficacy as well as new drug applications, clinical study reports, or publications.Participation in internal… more
- Merck & Co. (Rahway, NJ)
- …build and lead a team of TA dedicated global and regional directors and associate directors. The Executive Director , Value & Implementation (referred to as EDMA) ... Job DescriptionThe Executive Director , Value & Implementation (V&I), Global Medical and...real-world evidence data generation and coordinates local data generation studies with V&I Outcomes ResearchSupports the Investigator-Initiated Study… 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)
- …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. (Bernards, NJ)
- …a comprehensive understanding of the functional roles within Pharmacovigilance and Clinical TrialsAbility to extract configurable data fields from a study ... protocolProficient in FDA regulations supporting the submission of adverse events for post-marketing and investigative drugs. Understanding of global regulations preferredGood knowledge of Good Documentation PracticesEffectively manages shifting priorities;… 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
- 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
- Pfizer (New York, NY)
- The Associate Director , Clinical Diagnostics will support development of Diagnostics and Global Diagnostic Strategies across therapeutic areas. We are ... flow cytometry + An understanding of translational approaches as applied to clinical trial design and regulatory processes, proof-of-concept studies , and the… 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
- 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
- Mount Sinai Health System (New York, NY)
- …at Mount Sinai hospital. In collaboration with the MM Medical Director , the Associate Director , and the clinical trials investigators; this candidate is ... The Clinical Program Manager will report into Associate Director . **Qualifications** Education: + Bachelor's Degree...the protocol; and monitors test results, as appropriate Documents clinical study and therapy in patient's chart… 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- …hard copy and/or electronic solutions for data acquisition in MTPA clinical development studies . The Associate Director functions in a department with a ... oversight of data management for clinical development studies within all MTPA therapeutic areas. The Associate... studies within all MTPA therapeutic areas. The Associate Director works with departmental and cross-functional… more
- Mount Sinai Health System (New York, NY)
- …all safety aspects of clinical research trial(s). Under guidance of the Associate Director of Research and Quality Outcomes, the CRA is responsible for ... Events (SAE) for safety reporting, CEC and DSMB of clinical studies to ensure compliance with regulations...is responsible for reconciliation of drug safety databases and clinical study databases for adverse event reporting… more
- Mount Sinai Health System (New York, NY)
- …Determines final testing parameters/procedures in conjunction with the ordering physician or clinical director and laboratory protocols. 3. Reviews the patient's ... science. Advancing medicine. Healing made personal. **Title: Sleep Technologist-Pediatrics Sleep Study Lab - MSH - 6PM-7:30AM** **_The Sleep Technologist works under… more
- Pfizer (New York, NY)
- **ROLE SUMMARY** + Design, analyze, and interpret clinical trials and/or observational studies in compliance with relevant regulatory requirements, Pfizer ... and leadership to cross-functional activities, in collaboration with other statisticians, study managers, and programming colleagues, for assigned studies or… more
