Director of Clinical Quality

Revolution Medicines, Inc. is seeking an experienced and passionate Director of Clinical Quality to spearhead our quality assurance initiatives within our clinical operations. This pivotal role will focus on developing and implementing quality systems that ensure compliance with regulatory requirements and enhance the overall integrity of clinical trials. Th…

Role Overview Karius, Inc. is hiring a Director of Clinical Operations to strengthen clinical processes and uphold high standards across services. This leadership role calls for a strategic approach and deep experience in clinical operations. The Director will focus on refining workflows and supporting improved patient outcomes. Location This position is based in Redwood City, CA with a hybrid schedule, or can be performed remotely within the United States.

Join Revolution Medicines, Inc. as an Associate Director of Clinical Operations, where you will play a pivotal role in advancing the development of innovative therapies. This leadership position will involve overseeing clinical trial management, ensuring compliance with regulatory standards, and collaborating with cross-functional teams to drive project success.

Revolution Medicines is seeking a highly accomplished and visionary Executive Director of Clinical Development to lead our clinical programs. In this pivotal role, you will spearhead the development and execution of clinical strategies that drive the advancement of our innovative therapies. Your expertise will guide our clinical trials, ensuring they align with regulatory requirements and achieve optimal outcomes.

Revolution Medicines is seeking a dynamic and experienced Senior Director of Clinical Development to join our innovative team. In this pivotal role, you will lead and advance our clinical development strategy, overseeing the progression of our groundbreaking therapies from concept through to clinical trials. Your expertise in clinical research and development will be crucial in driving our mission to deliver transformative medicines to patients in need.

For over 25 years, Corcept Therapeutics has been dedicated to understanding cortisol, a critical hormone linked to a variety of diseases when not properly regulated.Our commercial portfolio features innovative treatments for hypercortisolism and oncology. With over 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists developed, Corcept is actively advancing clinical trials for conditions such as hypercortisolism, solid tumors, ALS, and liver disease. We are harnessing cortisol modulation to tackle some of the most challenging health issues faced by patients today.Headquartered in Redwood City, California, Corcept invites you to explore more about our mission and offerings at www.corcept.com.The Corcept Quality Systems Technology (QST) leader will be primarily responsible for evaluating Veeva Quality software projects and prioritizing critical initiatives for the QA department and Corcept. This role demands a strategic thinker who collaborates across functions to achieve mutual objectives, justifies software projects, and sets a clear path forward. The leader should be adept at managing complex system projects, supporting validation efforts as necessary, and overseeing project execution while ensuring strategic alignment.The ideal candidate will demonstrate the ability to convert business growth and increasing complexity into a cohesive software strategy, including a two-year framework that promotes sustained growth and organizational maturity. Projects will encompass new implementations, software enhancements, and ongoing process improvements.

Join Revolution Medicines, a pioneering late-stage clinical oncology company dedicated to developing innovative targeted therapies for patients suffering from RAS-addicted cancers. Our cutting-edge R&D pipeline features RAS(ON) inhibitors aimed at targeting various oncogenic variants of RAS proteins, including daraxonrasib (RMC-6236), elironrasib (RMC-6291), zoldonrasib (RMC-9805), and RMC-5127, all currently in clinical trials. As part of our dedicated team, you will collaborate with top-tier professionals committed to improving the lives of patients impacted by mutations in the RAS signaling pathway.The Opportunity:The Associate Director of Good Laboratory Practice Quality Assurance (GLP QA) will play a vital role in ensuring compliance with GLP standards at Revolution Medicines and its external vendors engaged in regulated activities.Your responsibilities will encompass overseeing GLP compliance for research laboratory vendors supporting regulatory clinical studies.You will develop and implement the annual vendor audit plan.You will conduct and manage vendor audits, including:Creating the audit plan, executing audits, and compiling reportsCoordinating audit closure tasks and reviewing vendor responses in collaboration with operational subject matter experts as necessaryProviding recommendations for vendor approvalsMaintaining vendor approval statuses in Veeva.You'll also participate in internal audits.Your role includes providing QA reviews of CRO study protocols and reports for compliance, employing a risk-based approach, and advising Nonclinical Development and Clinical Pharmacology (NDCP) teams on compliance matters.Monitoring vendor QA units to ensure adherence to applicable regulations, including reviewing vendor-specific QA audit reports.Advising sponsors on compliance requirements for test and control articles used in GLP studies.Collaborating and consulting with GLP vendor QA departments on study-related compliance issues.

Revolution Medicines is at the forefront of clinical oncology, dedicated to developing innovative targeted therapies for patients afflicted with RAS-addicted cancers. Our cutting-edge R&D pipeline features a range of RAS(ON) inhibitors aimed at targeting various oncogenic RAS protein variants, including daraxonrasib (RMC-6236), elironrasib (RMC-6291), zoldonrasib (RMC-9805), and RMC-5127, all currently advancing through clinical development. As a member of our dynamic team, you will join fellow professionals committed to making a meaningful impact on the lives of patients battling cancers linked to the RAS signaling pathway.The Opportunity:We are on the lookout for a seasoned clinical science drug developer to take on the role of Senior Director of Clinical Development, pivotal in supporting our clinical-stage molecules. In this essential position, you will oversee various clinical science deliverables, ensuring the effective execution of the clinical development plan for specific molecules within their respective indications. Your responsibilities will encompass early-stage clinical research through to pivotal studies, including regulatory submissions. You will play a crucial role in shaping the clinical science component of the Clinical Development Plan (CDP) strategy, driving the advancement of transformative therapies for patients.Lead the clinical science elements of the clinical development strategy and documentation.Represent the clinical development plans across relevant teams, ensuring effective training for study site personnel, acting as the main point of contact for inquiries related to the CDP at a program level, and overseeing medical/safety data reviews and study reporting.Potential assignment to complex and high-priority strategic studies for our molecules, with the expectation of exercising independent and self-directed leadership.Align cross-functionally with scientific, regulatory, and commercial objectives while executing the clinical development plan.Lead, mentor, and contribute to a high-performing cross-functional team of clinical development professionals, fostering a culture of collaboration, innovation, and excellence.Oversee all facets of clinical trial design and execution, including site selection, patient recruitment, data management, and regulatory compliance.

Position OverviewRevolution Medicines, Inc. is seeking an experienced and strategic Director of Clinical Data Management to lead our data management efforts in clinical trials. In this pivotal role, you will oversee the planning, development, and execution of data management strategies to ensure high-quality and timely delivery of clinical data. Your expertise will contribute to the advancement of our innovative therapies.Key ResponsibilitiesLead and manage the clinical data management team, ensuring adherence to timelines and regulatory requirements.Develop and implement data management processes, including data collection, cleaning, and validation.Collaborate with cross-functional teams to support clinical trial operations.Provide oversight for external vendors involved in data management activities.Ensure compliance with industry standards and best practices in data management.

We are seeking an experienced and dynamic Associate Director of Clinical Operations to join our team at Revolution Medicines. In this pivotal role, you will lead the planning, execution, and management of clinical trials, ensuring alignment with regulatory guidelines and company objectives. You will work closely with cross-functional teams to deliver innovative therapies to patients.

Revolution Medicines is hiring an Associate Director of Clinical Finance based in Redwood City, California. This position shapes the financial direction of clinical operations by managing budgets, forecasts, and financial analysis for clinical development programs. Key responsibilities Oversee the budgeting process for clinical programs, ensuring accuracy and alignment with organizational goals Lead forecasting activities to support both current and upcoming clinical development initiatives Analyze financial data to support informed decision-making and effective resource allocation Offer financial guidance to cross-functional teams throughout the organization Role impact This position plays a central role in making sure resources for clinical research and development are allocated efficiently, directly supporting Revolution Medicines’ work in the biopharmaceutical sector.

Join Revolution Medicines as the Director of Clinical Supply Chain, focusing on Comparators and External Collaborations. In this pivotal role, you will lead the strategic planning and execution of clinical supply chain operations, ensuring timely delivery of comparator drugs and oversight of external partnerships. You will collaborate with cross-functional teams to optimize our supply chain processes, drive efficiency, and contribute to the advancement of our clinical programs.

Join Revolution Medicines as an Associate Director of Clinical Development, where you will play a pivotal role in advancing our innovative drug development programs. You will collaborate with cross-functional teams to design, implement, and oversee clinical trials, ensuring exceptional execution and compliance with regulatory standards. Your expertise will contribute to our mission of delivering transformative therapies to patients with cancer.

Revolution Medicines, Inc. is seeking an experienced Associate Director of Global Quality Systems and Compliance to lead our quality management efforts. In this pivotal role, you will be responsible for developing and implementing quality systems that ensure compliance with regulatory standards and best practices. Your expertise will guide the organization in maintaining the highest quality standards across our operations, fostering a culture of continuous improvement.As a key member of our leadership team, you will collaborate closely with cross-functional teams to drive compliance initiatives, conduct audits, and ensure that all quality processes align with industry regulations. Your strategic vision and leadership will be instrumental in shaping our quality compliance roadmap.

The Associate Director of Clinical Operations Compliance & Training at Revolution Medicines focuses on upholding compliance and supporting training programs within clinical operations. This role is based in Redwood City, California. Role overview This position centers on maintaining the integrity of clinical operations by ensuring regulatory standards are met. The Associate Director will guide training efforts and help reinforce consistent practices across teams. Key responsibilities Oversee compliance activities related to clinical operations Lead and coordinate training initiatives for staff Promote adherence to regulatory requirements and internal policies Work environment This role operates within a biotechnology setting where attention to detail and commitment to regulatory standards are essential.

Revolution Medicines, Inc. is seeking an accomplished Executive Director of Clinical Supply Chain to lead our innovative supply chain strategy in the clinical trial landscape. This pivotal role involves overseeing the end-to-end clinical supply chain operations, ensuring timely and efficient delivery of supplies to support our groundbreaking therapeutic developments. The ideal candidate will possess extensive experience in clinical supply chain management, regulatory compliance, and cross-functional leadership.

Revolution Medicines is seeking a highly experienced and dynamic Senior Director of Clinical Data Management. In this pivotal role, you will oversee and enhance our clinical data management processes, ensuring the highest standards of data integrity and compliance. You will lead a talented team dedicated to supporting the clinical development of our innovative oncology therapies.Your expertise will be crucial in shaping our data strategy, implementing cutting-edge technologies, and fostering collaborations with cross-functional teams. Join us in our mission to transform cancer treatment!

Join Revolution Medicines as an Associate Director of Clinical TMF Management, where you will lead a team focused on ensuring the highest quality in clinical trial master file (TMF) management. Your expertise in clinical operations will be crucial in enhancing our processes and compliance.

Join Revolution Medicines as a Senior Medical Director of Early-Stage Clinical Development, where you will lead our innovative clinical programs aimed at the treatment of cancer. This is an exciting opportunity for a dynamic leader to make a significant impact in the clinical landscape.In this pivotal role, you will oversee the design, implementation, and management of early-stage clinical trials. Your expertise will guide teams in executing clinical strategies and ensuring compliance with regulatory standards.

Revolution Medicines develops targeted therapies for patients with RAS-addicted cancers. The company’s clinical pipeline includes RAS(ON) inhibitors aimed at specific oncogenic RAS protein variants, such as daraxonrasib (RMC-6236), elironrasib (RMC-6291), zoldonrasib (RMC-9805), and RMC-5127. The team is committed to advancing treatments for cancers driven by RAS pathway mutations. The Director of Stability Management, Analytical Development & Quality Control will lead outsourced stability studies for drug substances and products, spanning early clinical through commercial phases. This Redwood City-based position sets the direction for stability programs, ensures compliance with ICH and cGMP standards, and supports global regulatory submissions. Collaboration with internal teams and external partners is central to achieving clinical and commercial objectives. What you will do Set and execute the strategic direction for stability programs, aligning with ICH guidelines and regulatory standards. Supervise the design, execution, and management of stability studies for development, registration, and commercial phases. Collaborate closely with CMC, quality, regulatory, and clinical teams to achieve stability goals. Analyze stability data, perform trend and statistical analyses, and prepare reports to support retest and shelf-life extensions as well as storage recommendations. Work with quality teams during stability-related quality events or investigations and help implement CAPAs at contract organizations. Act as the primary contact for contract organizations on all stability-related activities. Oversee sample shipments, inventory tracking, and chain of custody for stability studies when required. Contribute to drafting CMC stability documentation for IND, NDA, AR, and IMPD submissions across all clinical and commercial phases. Requirements Extensive experience managing stability studies across commercial, late, and early clinical development stages. In-depth understanding of ICH and cGMP guidelines. Proven ability to collaborate effectively within cross-functional teams and with external partners. Experience contributing to global regulatory filings related to stability. Strong organizational and analytical skills.