- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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 (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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …of Phase I studies ; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, ... insight into the earliest stages of target identification and validation, and executing clinical studies to evaluate the relevance of potential targets to human… more
- Merck & Co. (South San Francisco, CA)
- …support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in internal and joint ... may:Supervise the activities of Clinical Scientists in the execution of clinical studies .Work closely with a cross-functional group of experts in… more
- Merck & Co. (North Wales, PA)
- …specific experience in clinical research and prior publication recordRequired Skills: Clinical Development, Clinical Studies , Clinical Trials, ... Director is responsible for protocol development and medical/ scientific oversight of clinical research studies involving new or marketed drugs in the Vaccines… more
- Merck & Co. (North Wales, PA)
- …biostatistical support for related drug/vaccine projects in Late Development Statistics. Lead the interaction with Clinical , Regulatory, Statistical Programming, ... assigned to a development project as neededLead biostatistics in early or late clinical development planning to ensure that study designs are consistent with… more
- Formation Bio (New York, NY)
- …the Clinical Development Strategy and Plans, including protocol development, for clinical studies . As part of this responsibility you will provide strategic ... input to and monitor the execution of clinical studies as a project physician.Your ability...landscape contribute to therapeutic areas strategy Based on the clinical trial design landscape contribute to study … more
- Merck & Co. (Rahway, NJ)
- …designing and analyzing clinical trials and coordinating the statistical activities for clinical trial projects; and may lead a group of statistical or ... the project as needed.-This includes the following activities:1. Is involved in late clinical development planning (LDP) to ensure that study designs are… more
- Insmed Incorporated (NJ)
- …Clinical /Manufacturing systems.Project lead experience preferred.Strong experience in Clinical Study Systems is required.Experience in evaluating and ... and FDA/EU regulations:21 CFR Part 11, Annex 11, GAMP 5, Good Clinical Practices, Data Integrity.Knowledge of the FDA Computer Software Assurance (CSA) fundamental… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …scientific engagement and communication- Serves as Global Medical Affairs Team (GMAT) Lead , to gain strategic and planning alignment across the matrix team ... as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, and Global Product Team to inform clinical… 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
