- 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
- Merck & Co. (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 DescriptionThe 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 supply risks… 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
- Merck & Co. (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 ... 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 cross-functional… more
- Merck & Co. (Rahway, NJ)
- …the Quantitative Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with teams… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and control of Clinical Project Budget in support of Phase I-III clinical studies .Partner with Project Management, Clinical Operations and other ... global business partners to develop budgets and analytics for ongoing and new pipeline studies in support of the annual process of extracting the optimal value out… 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
- 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …manufacturing to manage clinical development projectsAssist the Senior Director , Associate Vice-President/Vice-President and Product Development Team Lead in ... Job DescriptionThe Clinical Director (Principal Scientist) has primary...safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in… 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)
- …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
- 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
- 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
- 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
