- Actalent (South San Francisco, CA)
- Small Sponsor Company Job Title: Regional Clinical Study Lead Must be able to support West coast hours Travel Can be up to 40% + Oncology trial experience ... + 6+ years of industry experience- Prior monitoring experience Job Title: Clinical Study Lead Job Description This role involves the regional operational… more
- BeOne Medicines (San Mateo, 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
- IQVIA (Oakland, CA)
- …equipment provided._ **What You'll Do** + Lead data management for complex, global clinical trials from study setup to database lock. + Serve as the main ... data management experience, with 5+ years in a Lead Clinical Data Management role. + Your...Project Manager_ . + Proven success managing large global studies (1000+ patients). + Expertise with Medidata Rave, Oracle… more
- Roche (South San Francisco, CA)
- …Join our Clinical Sourcing & Partnerships (CSP) function as the Enterprise Clinical Service Provider Lead to drive the strategic management and performance ... management in clinical development, or extensive direct experience working with clinical suppliers in performance management at a study and portfolio level.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …inflammation programs, ensuring scientific rigor and regulatory compliance. + Serve as the clinical lead on cross-functional study teams, providing medical ... lifecycle. + Analyze and interpret clinical trial data; contribute to clinical study reports, regulatory submissions, and publications. + Collaborate with… more
- Genentech (South San Francisco, CA)
- …learning. Other responsibilities may include planning, writing, and reviewing relevant clinical documents such as study protocols, analysis plans, reports, ... leading the design, conduct, and reporting of Clin Pharm studies , as well as other M&S strategy/support such as...plus + Experience working on cross-functional teams as a Clinical Pharmacology Lead and/or Modeling & Simulation… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with experience in medical monitoring and addressing medical concerns that arise during clinical studies , experience leading study concept and protocol ... You will provide scientific and clinical leadership on activities including clinical development plan generation; clinical study planning, conduct, and… 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
- Edwards Lifesciences (San Francisco, CA)
- …to strategy and planning of clinical science and medical writing deliverables. + Lead clinical study design and clinical protocol development. + ... providing scientific expertise throughout the development and implementation of clinical studies and clinical evaluations...Independently author complex documents including clinical study protocols (pre-market and post-market), … more
- Gilead Sciences, Inc. (Foster City, CA)
- … trial sponsor oversight, deviation management and internal audit support. + Lead Clinical Operations on internal deviations activities, including project ... FDA, EMA, and ICH GCP and other applicable regulations governing the conduct of clinical studies . + Ability to build strong relationships to foster a… more
- Pfizer (South San Francisco, CA)
- …management support of one or more R&D Internal Medicine clinicians on one or more clinical studies or across a clinical program. **Job Responsibilities** + ... studies and works in close partnership with other clinical and medical colleagues, clinical operations, and... clinical documents + Inputs and reviews the Clinical Study Report including the review of… more
- Pfizer (South San Francisco, CA)
- …provide matrix management support of one or more IM clinicians on one or more clinical studies or across a clinical program **Job Responsibilities** + ... studies and works in close partnership with other clinical and medical colleagues, clinical operations, and... clinical documents + Inputs and reviews the Clinical Study Report including the review of… 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
- Genentech (South San Francisco, CA)
- …us Roche!** As a Global Clinical Supply Chain Leader (CSCL), you will lead the clinical study supply chain of Investigational Medicinal Products (IMP), ... will work closely with stakeholders to align supply chain strategies with clinical trial milestones, ensuring continuous and patient-centric delivery of IMP. In this… more
- BeOne Medicines (San Mateo, CA)
- …(SCS/ISS, RMPs, initial Package Inserts) collaborating with PSLs and other Clinical Study Team (CST) members. + Lead the authoring of Storyboards and ... in conjunction with Product Safety Leads (PSLs) and leverages clinical and scientific expertise to lead the...Plans, CSRs (incl. China ADR Summary) and other relevant project/ study documents and answer ad-hoc safety queries from ethics… more
- Astellas Pharma (South San Francisco, CA)
- …candidate should demonstrate deep understanding of cancer biology and immune-oncology, and lead pre- clinical in vivo research focused on understanding the ... in vivo pharmacology scientists to increase the probability of clinical success for oncology therapies. This position will be...+ Design, plan, and supervise anti-tumor efficacy and PK/PD studies in mice + Lead the efforts… more
- BeOne Medicines (San Mateo, 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
- Abbott (Santa Clara, CA)
- …Director, Clinical Study Management overseeing a global portfolio of 100+ clinical studies across six business units in our Medical Devices division. Why ... across multiple business units. **What You'll Work On** + Lead the project management of global clinical ...clinical trials with budgets exceeding $100MM. + Influence study design allowing for seamless study execution.… more
- BeOne Medicines (San Mateo, CA)
- …_Line management responsibilities:_ + Provides leadership, management, and/or mentorship to clinical study managers at various levels for assigned portfolio ... to ensure the needs of the business are met. + Contributes to overall Clinical Operations strategy for the region and is accountable for performance against key… more