- Gilead Sciences, Inc. (Foster City, CA)
- …as we strive to cure unmet medical needs? R&D Quality is seeking a Director , R&D Audit Program - GCP to join our Audit, Inspection and CAPA Management ... In this role you will be responsible for leading GCP audit activities for Clinical Investigator sites,...+ Oversee external consultants and audit partner activities for quality deliverables. + Provide metrics for effective reporting of… more
- Actalent (Malvern, PA)
- Job Purpose The Director of Clinical Quality ... clinical trial sites. Duties and responsibilities Provide quality leadership for clinical GCP ... for excellence in GCP activities for sponsored clinical studies across the varied company portfolio. This role...(eg, INDs, BLAs, Annual Reports); ensure compliance with SOPs, Clinical Quality processes, and regulatory standards. Develop… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Quality is seeking a Senior Director , Inflammation TA Lead to join our Clinical Quality Business Partners Leadership Team. In this role you will lead and ... + Must have broad GCP audit and compliance experience. Clinical Quality Assurance/Compliance experience in a Bio-pharma sponsor organization required.… more
- University of Pennsylvania (Philadelphia, PA)
- …health and wellness programs and resources, and much more. Posted Job Title Director , Clinical Research Operations (Department of Dermatology) Job Profile Title ... Director , Clinical Research Operations Job Description Summary... of research. Direct the development and implementation of clinical operations quality systems, including SOPs, document… more
- e CancerCare (Fresno, CA)
- Purpose: The Director , Clinical Trials & Research, for CCARE Physicians, PC, is responsible and accountable for the daily operations and management of staff, of ... Assures compliance with all regulatory requirements and standards of good practice ( GCP ) related to the conduct of clinical research. Responsibilities/Essential… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- … to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the development, evaluation, planning and execution ... studies and ensures scientific integrity and interpretation of study data of a clinical development program. The Associate Director leads in a matrix environment… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Clinical Operations Pleasanton, CA, USA * Princeton, NJ, USA Req #367 Wednesday, May 8, 2024 Looking for a chance to make a meaningful ... and manages multiple complex global studies to support the Clinical Development Plan. The Associate Director (AD)...the investigator follows the approved protocol, training and all GCP procedures and oversees the quality of… more
- CSL Behring (King Of Prussia, PA)
- …used to treat serious and often rare conditions. Could you be our next Director of Clinical Portfolio Execution? This position is located in our King ... multiple direct reports. You will report to the Senior Director of Clinical Portfolio Execution. **Responsibilities:** **You...process development.** **Knowledge of ICH GCP , FDA GCP Regulations and EU clinical trials directives.**… more
- University of Colorado (Aurora, CO)
- … clinical research leaders to establish standardized processes for performing high quality clinical trials within their functional areas as warranted by the ... Associate Director or Director of Clinical...involved stakeholders. + A strong working knowledge of Good Clinical Practices ( GCP ), US Food and Drug… more
- Teva Pharmaceuticals (West Chester, PA)
- Director Clinical Development - Oncology Date: May...group + Ensures clinical trials comply with clinical guidance, ICH, GCP , in agreement with the ... clinical programs worldwide across all phases of clinical research. The Director will oversee study... results and provide a guidance to prepare high quality reports working with Medical Writing + Responsible for… more
- Actalent (Gaithersburg, MD)
- Director of Clinical Operations Support the...for clinical monitoring and data management of clinical trials Ensure the delivery of high- quality ... Manage Contract Research Organizations (CROs) effectively to ensure that clinical studies are conducted to the highest quality...in establishing Risk Management plans and strategies per ICH GCP E6 (R2) Experience in managing CROs, clinical… more
- BeiGene (Emeryville, CA)
- **General** **Description:** The Senior Director of CMO and Distribution Logistics, Clinical Supply Chain is responsible for overseeing the Clinical Supply ... strong relationships with BeiGene functional leadership (including but not limited to clinical Operation, Quality , Regulatory, CMC, and GRDS) to ensure alignment… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …therapeutic candidate * Ensures Clinical Team compliance with FDA, EMEA, ICH and GCP guidelines as well as SOPs regarding safety * Authors clinical sections ... The Associate Medical Director works with their supervisor and other members...others; provide input on potential disease areas/indications; and craft clinical experiments that corroborate or inform the biology for… more
- University of Rochester (Rochester, NY)
- …of approximately 15 team members, with two Directors ( Director Operations and Director Quality Assurance) and the clinical trials it supports in ... to secondary packaging, labeling, blinding, distribution and return services of clinical supplies (drugs and devices). **SPECIFIC RESPONSIBILITIES:** We are looking… more
- Arvinas (New Haven, CT)
- Arvinas is a clinical -stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the ... against validated and "undruggable" targets, the company has three investigational clinical -stage programs: ARV-766 and bavdegalutamide for the treatment of men with… more
- J&J Family of Companies (West Chester, PA)
- Director Clinical Operations DPS - 2406189771W **Description** Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers ... well executed clinical studies, for the supported franchises delivering high quality clinical data to support Regulatory, Market Access, Reimbursement and… more
- Gilead Sciences, Inc. (Seattle, WA)
- …Join Gilead and help create possible, together. **Job Description** The Associate Director , Clinical Records & Information Management will partner with cross ... implementation of the TMF technical capabilities and oversight of standardization, training, quality , and timely clinical trial documentation across the … more
- BeiGene (San Mateo, CA)
- The Associate Director (AD) Clinical Study Management leads both indirect and direct reports, external partners, consultants, vendors and external budget to ... and investigators + Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials required Demonstrates a… more
- J&J Family of Companies (Jacksonville, FL)
- Associate Director Clinical Logistics - 2406191308W **Description** At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation ... Johnson Vision on LinkedIn. **Position Summary** : The Associate Director , Clinical Logistics develops strategies to address...practices of clinical research procedures and Good Clinical Practice ( GCP ). * Broad understanding of… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- We are seeking an **Associate Director - Clinical Trial Management** to join our Oncology team as a part of our new Regeneron Cell Medicines (RCM) group. You will ... of project risks and contingency planning. **As an Associate Director - Clinical Trial Management, a typical day...staff to ensure trial(s) are managed to the highest quality + Forecasting trial resource needs (external costs), being… more