- 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
- 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
- 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. (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. (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. (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
- 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. (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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ensure high data quality, proactively identifying and resolving issues throughout the clinical trial process. Customer Focus / Stakeholder:Engagement Lead the ... direction for respective interventional/non-interventional programs such as post marketing studies or post approval commitments, medical access programs.Partner with… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …pivotal role in guiding toxicology strategy from early research through IND-enabling studies and into clinical development, ensuring regulatory compliance and ... strategic input to project teams across discovery, preclinical, regulatory, and clinical functions.Manage non-GLP and GLP-compliant studies conducted at CROs;… more
- Eisai, Inc (Pittsburgh, PA)
- …Maintain and demonstrate thorough and up-to-date knowledge of disease state, study methodology, clinical information, and product data.Demonstrate full knowledge ... and scientific expertise to Investigators involved in company sponsored post-marketing studies . Professional Organization Support Lead field medical efforts in… more
- Merck & Co. (Rahway, NJ)
- …therapeutic area and encourages appropriate application of new methods to HEOR studies .Maintains responsibility to ensure study conduct is aligned with company ... agencies, and health systems globally. The ability to successfully participate in and lead cross-functional teams is a critical part of this role. The Executive… more
- BioAgilytix (San Diego, CA)
- …Manager II will lead scientific and operational activities in support of preclinical, clinical , and product release studies for our San Diego lab. This role ... team(s) developing and validating bioanalytical assays for support of preclinical, clinical and product release studies .Motivating team by inspiring employees… more
- Eisai, Inc (San Diego, CA)
- …imaging aspects required, from protocol development to final analysis and clinical study reporting.Familiarity with oncology image-based tumor response criteria ... design-including modality selection, timing, and anatomical coverage-to ensure alignment with study endpoints and biomarker objectives across Eisai's clinical … more
