- 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
- 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
- Eisai, Inc (Philadelphia, PA)
- …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
- 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …the ability to influence at all organizational levels.Experience integrating HF into clinical trial design and execution.Demonstrated ability to manage multiple ... our company. This role leads a center of excellence team within Device Development & Technology (DD&T) engaged across the entire product lifecycle-from early … more
- Insmed Incorporated (NJ)
- …Associate Director of Biostatistics is responsible for the statistical aspects for complex clinical trial (s) or indication product line. This role leads the ... section development , study setup, execution, analysis, and reporting of clinical trials, and interacts with cross-functional teams.What You'll Do: Lead … more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The** **Position** The Clinical Trial Manager (CTM), Translational Medicine and Early Development (TMED) is responsible for assisting ... TMED Operations. The CTM will support the TMED Operations Lead to plan and execute studies including, but not...Competencies + Phase 1 study operations + ICH/GCP + Clinical research + Clinical development … more
- Merck & Co. (Rahway, NJ)
- …development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process ... Driving License:NoHazardous Material(s):n/aRequired Skills:Analytical Method Development , Assay Development , Bioanalytical Analysis, Business, Chromatographic Techniques, Clinical … more
- Sanofi (Swiftwater, PA)
- …Leader (IBOL)-Global Budget Manager- Vaccines Location: Swiftwater, PA About the Job Global Clinical Development has the largest budget and spend in R&D, due ... They have strong participation in associated processes, taking the lead on one or more key aspects. They incorporate...Query, and either Power BI or Tableau is mandatory. Clinical Trial operational experience, experience in the… more
- Insmed Incorporated (NJ)
- …Role:The Medical Director for Interstitial Lung Diseases will develop, implement, and lead the therapy portfolio strategy and planning for Medical Affairs across all ... geographic regions ensuring a cohesive approach. This role will develop and lead all medical affairs activities ensuring partnership within the team (medical… more
- GRAIL (Menlo Park, CA)
- …technology, and healthcare companies. For more information, please visit grail.com . The Sr. Clinical Trial Manager serves as a clinical operations leader, ... ability to be flexible and creative yet ensuring the clinical trial is executed within compliance of... Clinical Operations. **Responsibilities:** + Serves as the Clinical Operations Study Lead for assigned studies,… more
