- Organon & Co. (Plymouth Meeting, PA)
- …The Clinical Pharmacology Lead will ensure the scientific and clinical pharmacology components of study protocols are sound, based on the most ... collaboration with the TMED operations lead and study biostatistician), analysis and interpretation of TMED studies... studies , in collaboration with the TMED operations lead , bioanalytical or modeling leads, procurement and clinical… more
- Organon & Co. (Jersey City, NJ)
- …test articles, study records, etc.), and on-site monitoring of non- clinical studies at specific milestones. Additionally, this position will interface ... **Job Description** **The Position** The Non- Clinical Operations Lead within the Non-...Team (NCD), is responsible for operational oversight conduct outsourced non- clinical studies at contract research organizations (CROs),… more
- BeOne Medicines (Emeryville, CA)
- …ensure feasibility, study start-up, site management, drug supply and other clinical studies ' activities operating according to GCP and Health Authorities' ... mission. Leveraging deep therapeutic and functional area expertise, the Clinical Operations Lead in Biotech Unit is...efficient study planning and execution of associated clinical programs/ studies + Conduct regular review meetings… more
- 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 or ... medical/ clinical queries from health authorities. Leadership and Collaboration: Lead cross-functional teams in clinical development, medical affairs, and… more
- Parexel (Columbus, OH)
- …of contact for resolution. - Maintain and review metrics related to clinical study samples, data, kits, and logistics. - Lead cross-functional study ... is required. The candidate will develop, drive, and handle clinical study related tasks for the team...and issues with an awareness of the impacts to clinical studies /program. - Strong problem-solving, project management,… more
- Eisai, Inc (Nutley, NJ)
- …(DDP)Leads the development of Clinical Protocols to meet CDP objectives.Serves as Study Director/ Clinical Pharmacology Lead and drives the execution of ... study data.Implements strategies to identify, monitor and resolve clinical program/trial issues.Interprets study data and develops integrated summaries… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ensure compliance with Daiichi Sankyo's quality measures. Analyze CRO performance trends within a clinical study or across several studies and resolve or ... and implement appropriate innovative and best-in-class procedures and SOP's related to clinical study oversight and execution.Ensure their direct reports are… more
- Insmed Incorporated (San Diego, CA)
- …You'll Do: Participate in cross functional teams to develop and implement clinical studies within clinical program(s). Responsibilities include but ... research organizations (CROs), and external vendors to prepare, review and finalize clinical study documents and plansContribute to scientific and operational… more
- Insmed Incorporated (NJ)
- …competencies.Works collaboratively with Clinical Scientist, Clinical Indication/Development Lead , and clinical study team to ensure ongoing ... quality, cost, and timeline parameters.Effectively manages and/or assists with cross-functional clinical study team and team members to achieve deliverables… more
- CSL Behring (King Of Prussia, PA)
- …of the program** **providing clinical oversight and expertise during development of clinical studies ** **serves as medical monitor for assigned clinical ... worldwide. Could you be our next Senior Director, Global Clinical Program Lead , Cardiovascular? The job is...(CDP), the Project Strategy Document (PSD), Investigator Brochures (IB), Clinical Study Protocols (CSP), Informed Consent Forms… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …accurate and complete study team list is maintained.-In partnership with the lead physician, Clinical Scientist and all study team members, accountable ... (SDL) leads the cross functional core and extended clinical study team in end-to end delivery...insourcing. This includes global operational execution and delivery of clinical studies across multiple geographic regions, in… more
- Terumo Neuro (Aliso Viejo, CA)
- …training initiatives that elevate the performance of the company's sales and clinical teams. Lead programs that integrate selling skills, business acumen, ... training programs for new hires and tenured associates across clinical , technical, and commercial competencies. + Lead ...education, Business, Life Sciences, or a related field of study . 2. Minimum eight (8) years of experience in… more
- GRAIL (Menlo Park, CA)
- … Clinical Operations. **Responsibilities:** + Serves as the Clinical Operations Study Lead for assigned studies , providing strategic and operational ... are using the power of next-generation sequencing (NGS), population-scale clinical studies , and state-of-the-art computer science and...trials, with at least 2 years experience in a Clinical Operations study lead role,… more
- Arvinas (New Haven, CT)
- …this role include, but are not limited to: ** Clinical Document Development** + Lead the development of clinical study protocol synopses and full ... evaluating, and presenting scientific and medical data, writing or providing content to clinical documents ( clinical study protocols and protocol synopses,… more
- Formation Bio (New York, NY)
- …quality, cost control, and on-time deliverables. Serve as the Operations Lead for clinical assets and associated studies . Step in as the Clinical Project ... Oversight Provide strategic and tactical guidance for ongoing and newly launched clinical studies , ensuring alignment with corporate and asset development goals,… more
- CSL Behring (King Of Prussia, PA)
- …of Clinical Development Medical Writing Deliverables, including Investigators Brochure (IB), the Clinical Study Outline, The Clinical Study Protocol ... Lead helps to drive quality scientific and operational clinical development execution, by forming, building and developing a...to the development and maintenance of the IB, the Clinical Study Outline, Regulatory Briefing Books, Module… more
- BeOne Medicines (San Carlos, CA)
- …Clinical Biomarker Scientist to lead biomarker strategy and execution in clinical studies . The role involves designing and analyzing biomarker studies ... + Serve as the primary biomarker scientist for the clinical study team, ensuring biomarker strategies are...with and manage external vendors and collaborators involved in clinical studies or translational research, including vendor… more
- Parexel (Olympia, WA)
- Works with Precision Medicine Strategy Lead as well as clinical study teams, data management (DM) team, Samples, Kits, Data, Logistics (SKDL) and Clinical ... Management** Study Team Support + Supports individual clinical study teams as required for all...Acquisition and Management + Works closely with data management lead to determine how sample and testing data will… more
- BeOne Medicines (Emeryville, CA)
- …Franchise Head will lead and manage the Global Clinical Program Lead (GCPL)/ Global Clinical Study Manager (gCSM) group in designated Franchise(s)- ... efficient study planning and execution of associated clinical programs/ studies + Conduct regular program review...lead efforts to deepen scientific knowledge within the Clinical Operations' function + Champions a global mindset and… more
- BeOne Medicines (San Mateo, CA)
- …regular updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional study team ... at internal meetings and at the cross-functional Clinical Study Team (CST) meetings + Leads...biotech, pharma or CRO industry + Proven experience in clinical research including relevant experience as team lead… more
