- Insmed Incorporated (NJ)
- …over an 1-2 indications within one compound, in collaboration with the Senior Director , Clinical Operations . Ensures consistent and successful execution of ... budget and with high quality. This role may manage clinical operations team members, as delegated by...operations , project management, the drug development process, and clinical trial conduct, including systems and procedures,… more
- Formation Bio (New York, NY)
- …of the scientific landscape contribute to therapeutic areas strategy Based on the clinical trial design landscape contribute to study design and planning ... strategy Operational Excellence: Drive/contribute to trial operations and medical processes to achieve...Training: Clinical training for internal stakeholders and clinical trial sites (eg overviews of specific… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …acquisition, validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements ... are crucial for this role. Advanced knowledge of Data Management, Biostatistics, Clinical Operations , Pharmacovigilance, handling and processing of raw data and… more
- Insmed Incorporated (NJ)
- … clinical projects. Collaborates with cross-functional team members within Biometrics, Clinical Operations , Regulatory, and Clinical Development, as well ... statistical software packages Significant knowledge of the drug development process, clinical trial methodology, and relevant regulatory requirements for drug… more
- Merck & Co. (Rahway, NJ)
- …limited to Investigational New Drugs, Investigational Medicinal Product Dossier s, and Clinical Trial Application s.Ability to work closely with cross-functional ... with other teams within BPD and staff in Process Cell Science, US Operations , Clinical Manufacturing, and Commercial Manufacturing groups. The candidate should… more
- Formation Bio (New York, NY)
- …milestone treatment Partners with Director of Accounting, R&D, FP&A, and clinical operations to ensure accurate financial treatment of scientific and ... Expertise Oversees application of GAAP to biotech R&D activities, including clinical trial accruals, collaboration cost-sharing, milestone recognition, and… 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 ... and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of...of a risk-based quality management process fully embedded through trial design, execution and submission including all vendor managed… more
- Insmed Incorporated (Minneapolis, MN)
- …insights to Insmed.Support research and development programs as requested by R&D, Clinical Operations , and Medical Affairs Departments. This may include ... strong related experience.Other Pharmaceutical experience - Medical Information, Medical Strategy, Clinical management/ trial experience and 2 years clinical … more
- Insmed Incorporated (NJ)
- …GMPs and internal standards.Serve as the Quality lead for GMP activities supporting clinical trial materials, including DS/DP used in early and late-phase ... change controls, and protocols/reports.Collaborate cross-functionally with CMC team, Regulatory, Clinical Operations , and Program Management to drive proactive… more
- Insmed Incorporated (NJ)
- …milestones in launch planning.Medical leadership input for cross functional partners including clinical , operations , HEOR, and commercial to ensure that there is ... for the future of science, we're in. Are you?About the Role:The Medical Director for Interstitial Lung Diseases will develop, implement, and lead the therapy… more
- Insmed Incorporated (St. Louis, MO)
- …insights to Insmed.Support research and development programs as requested by R&D, Clinical Operations , and Medical Affairs Departments. This may include ... and infectious diseaseOther Pharmaceutical experience - Medical Information, Medical Strategy, Clinical management/ trial experience and 2 years clinical … more
- CytomX Therapeutics, Inc. (South San Francisco, CA)
- Description TEMP Clinical Trial Assistant, Senior Clinical Operations Headquarters Location: South San Francisco, CA Candidate Location: Hybrid Travel ... Required: 5% Reports To: Sr. Director , Clinical Operations Department: ...CTA will have experience with and an understanding of clinical trial conduct including study start-up and… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** The Director of Digital Clinical Operations Solutions is a member of the Digital GCO Leadership Team, responsible for leading a team ... Operations ' productivity, reduce rising costs of clinical trials, and reduce clinical trial... Operations ' productivity, reduce rising costs of clinical trials, and reduce clinical trial… more
- JENAVALVE TECHNOLOGY INC (Irvine, CA)
- …Oversee the training/coordinating of subject presentation materials for CRB meetings with clinical trial sites. Collaborate with cross functional team leaders to ... Manage and maintain relevant electronic data management platform activities related to clinical trial enrollment. Mentor and provide leadership to junior … more
- BeOne Medicines (Emeryville, CA)
- …colleagues in clinical development, program leadership, biometrics, clinical operations , safety/pharmacovigilance, regulatory, molecular diagnostics, and ... + Clinical Development Plans + Partner with clinical operations and other functional areas for...Provide scientific and medical support throughout conduct of a clinical trial ; respond to clinical … more
- BeOne Medicines (San Mateo, CA)
- …of 12 years of combined experience in Feasibility, Clinical Trial Management, Personnel Management and Operations Management. All qualified applicants ... **General Description:** As the Regional Strategic Feasibility Lead within Global Clinical Operations (GCO), you will play a vital role in collaboration with the… more
- BeOne Medicines (Emeryville, CA)
- …staffing levels that will enable the delivery of the BeOne clinical trial portfolio. Reporting to the Director of Global Resource Management, this individual ... context of Resource Management + Partner with sub-functions across Global Clinical Operations (GCO) as needed to support resourcing needs. + Portfolio Resource… more
- BeOne Medicines (San Mateo, CA)
- …data products that address critical R&D use cases (eg, portfolio insights, clinical trial optimization, regulatory intelligence). + Establish best practices for ... As Director of R&D Data Enablement / Data Products,...+ Expertise in R&D data domains and lifecycle (Research, Clinical Development, Clinical Operations , Global… more
- BeOne Medicines (San Mateo, CA)
- …of 8 years of combined experience in Feasibility, Clinical Data Analytics, Clinical Trial Management, and Operations Management. *Exceptions may be made ... analytics and systems, the Global Strategic Feasibility Analytics Lead collaborates with clinical development and clinical operations stakeholders to foster… more
- IQVIA (Washington, DC)
- …reporting directly to the Director of Clinical Affairs, to support clinical trial operations for the firm's clientele.** **Position Overview** **The ... Clinical Trial Associate (CTA) supports the In-House Clinical Research Associate and clinical Trial Manager to ensure optimal management of essential… more
