- Lupin Pharmaceuticals (Coral Springs, FL)
- OverviewThe Respiratory Clinical Development Medical Lead will oversee the clinical and medical aspects of new respiratory medicines, including new drug ... medical/ clinical queries from health authorities. Leadership and Collaboration: Lead cross-functional teams in clinical development , medical… more
- Formation Bio (New York, NY)
- …Business Development product assessment strategy and execution, lead the development of the Clinical Development Strategy and Plans, including ... medical processes to achieve continued innovation and improvement Utilize your clinical development and trial execution experience to develop creative ways… more
- Merck & Co. (North Wales, PA)
- … Director at this level will be expected to lead a Product Development Team (PDT) through late-phase clinical development and into post-licensure ... and efficacy, as well as analysis, interpretation, and reporting of final clinical trial results.In addition to responsibilities associated with clinical… more
- Eisai, Inc (Nutley, NJ)
- … Pharmacology will be relied upon to act independently, within a highly-matrixed clinical development organization and must have the experience and conviction to ... to established design principals and integrates them into the Clinical Development Plan (CDP) and Drug ...Clinical Protocols to meet CDP objectives.Serves as Study Director/ Clinical Pharmacology Lead and drives the execution… more
- Sanofi (Cambridge, MA)
- …Pharmacology, Operations and Evidence Generation & Decision Science), Early Development Clinical Operations (EDCO, including Clinical Trial Managers and ... Job Title: Clinical Lead , Early Clinical ...Evidence Generation & Decision Science), Early Development Clinical Operations (EDCO, including Clinical Trial… more
- Eisai, Inc (Nutley, NJ)
- …3 years MSL experience in Oncology/Hematology.Strong broad-based scientific and pharmaceutical knowledge. Clinical trial development and drug launch ... and oncology, with a strong emphasis on research and development . Our history includes the development of...and its hhc mission; b) provide key scientific and clinical information about Eisai's products; provide a conduit for… more
- Merck & Co. (Rahway, NJ)
- …in designing and analyzing clinical trials and coordinating the statistical activities for clinical trial projects; and may lead a group of statistical ... general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/ III...needed.-This includes the following activities:1. Is involved in late clinical development planning (LDP) to ensure that… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …acquisition, validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements ... acceptance and reconciliation reports, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements.Oversees… more
- Merck & Co. (Rahway, NJ)
- …identifying and implementing novel quantitative approaches (for eg, comparator modeling, clinical trial simulations,- quantitative system pharmacology (QSP) and ... and productive interactions among diverse personalities/areas of expertise#QP2#EligibleforERPRequired Skills: Clinical Trial Designs, Clinical Trial… more
- Genmab (NJ)
- …The Senior Manager, Biostatistics acts as a biostatistician supporting the clinical development of compounds as compound lead , primarily up until proof of ... synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reportsCoordinate data transfers from/to business partners… more
- Eisai, Inc (San Diego, CA)
- …across its development portfolio. This role offers the opportunity to lead high-impact imaging strategies-from trial design and execution to data ... and radiomics) to ensure imaging strategies are optimized for clinical trial design and aligned with scientific...site imaging manuals, and transmittal forms-and contribute to the development and approval of clinical data transfer… more
- Sanofi (Morristown, NJ)
- …strategies. This position extends beyond the classical patient insights generation and clinical trial operations activities by having direct accountability for ... patient relevant business insights, to inform the PDS, the Clinical Development Plan, the Integrated Patient Journey... Plan, the Integrated Patient Journey (IPJ) and the clinical trial designs is core to ensuring… more
- Merck & Co. (North Wales, PA)
- …programming activities for multiple and/or large/complex late-stage drug/vaccine clinical development projects.Develop and execute statistical analysis ... and maintain statistical databases that support multiple stakeholder groups which include clinical development , outcomes research and safety evaluation.Act as a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …quality, proactively identifying and resolving issues throughout the clinical trial process. Customer Focus / Stakeholder:Engagement Lead the implementation ... (QRBs).Collaborate with business process owners to monitor the effectiveness of clinical development processes through KQIs, demonstrating process control and… more
- Insmed Incorporated (NJ)
- …internal standards.Serve as the Quality lead for GMP activities supporting clinical trial materials, including DS/DP used in early and late-phase ... and manufacturing organizations (CDMOs), and other GxP vendors used for clinical trial materials and services. Establish QA-QA relationships and checkpoints… more
- Sanofi (Morristown, NJ)
- …affairs, biostatistics, drug discovery, drug safety, marketing Advance the clinical development plan through internal management review Lead a clinical ... Therapeutic Area is responsible for the creation of the clinical development plan in alignment with the... strategy and plans for one or more assets Lead and coordinate cross-functional teams to design, implement, and… more
- Sanofi (Cambridge, MA)
- …and written communication skills Relevant disease area knowledge working directly on clinical trial protocols and data reporting in industry setting ... Job Title: Biostatistics Lead , Next Generation Immunology Location: Cambridge, MA Morristown,...conducting statistical analyses from human Phase 3 or 4 clinical trial data, either pre-planned and post-hoc… more
- Insmed Incorporated (San Diego, CA)
- …data systems. The candidate will collaborate closely with the Biometrics teams, Clinical Operations teams, Clinical Development teams, Regulatory Affairs, ... data integrity, system reliability, and regulatory compliance across all phases of clinical development .Team Leadership & Collaboration: Mentor and guide junior… more
- Merck & Co. (Rahway, NJ)
- …(AQIP), Academic Quality Improvement Program (AQIP), Adaptability, Budget Development , Clinical Supply Chain Management, Clinical Trial Management, ... with clear roles & responsibilities, governance forums, KPIs, and service delivery expectations. Lead development and adoption of data policies, standards, and… more
- Insmed Incorporated (NJ)
- …stakeholders across the company including market access, marketing, medical affairs, and clinical development to understand and support Insmed's business needs. ... This is a global role.What You'll Do: Lead development of HEOR strategy for gene...burden of illness studies, patient reported outcomes studies and clinical trial endpoint selection, disease natural history,… more
