Senior Director, Clinical Operations (Biotech, Oncology) Exelixis Inc.Senior Director, Clinical Operations (Biotech, Oncology)Alameda, CA$246,000–$349,500 / yearAs a Senior Director, oversees large clinical programs and represents Clinical Operations on internal and external strategy teams, including Product Development Teams (PDTs) which entails accountability for the operational strategy and successful execution of all Clinical Development Plans related to your assigned programs, including financial accountability. Oversight of quality delivery by leading the Clinical Operations team to ensure excellence in operational planning and implementation; and being the escalation point for the program in Clinical Operations; ensuring inspection readiness at all times and having regular interactions with Study Delivery Leads involved in the program such that they are aware of issues / risks / successes with study delivery as they occur.
Associate Director, Clinical Operations (SF Bay Area) Structure Therapeutics IncAssociate Director, Clinical Operations (SF Bay Area)South San Francisco, CA$186,000–$220,000 / yearCross-Functional Collaboration: Work closely with Preclinical, Biostatistics, Data Management, Clinical Supplies, Safety/PV, and Medical Affairs teams to ensure seamless study execution and IMP accountability, including sample management and study plan reviews. The company's platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs.
Associate Director, Clinical Operations Structure Therapeutics IncAssociate Director, Clinical OperationsSouth San Francisco, CA$186,000–$220,000 / yearCross-Functional Collaboration: Work closely with Preclinical, Biostatistics, Data Management, Clinical Supplies, Safety/PV, and Medical Affairs teams to ensure seamless study execution and IMP accountability, including sample management and study plan reviews. The company's platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs.
Vice President, Clinical Operations Nuvation Bio IncVice President, Clinical OperationsSan Francisco, CAWorks with Clinical Operations team on CRO/vendor qualification and selection processes for outsourced activities, including scope of services agreements, budgets with unit cost negotiation, clinical and translational operational plans, and detailed timelines, and ensure that high-performance expectations are met. Shapes the Clinical Operations strategy and translates the strategy into an operational risk management plan by identifying and appropriately escalating trial and program risks to the Clinical R&D leadership team and the Executive Committee.
Senior Manager/Associate Director Clinical Operations Lycia TherapeuticsSenior Manager/Associate Director Clinical OperationsSouth San Francisco, CARemote$169,000–$198,000 / yearAbility to manage in a consensus environment through teamwork, trust and shared expectations, influencing strategic direction of complex global clinical operations issues, solicit information, listen well, persuade others, make important decisions and shape outcomes. Build, develop and train internal staff and external vendors, structure department for enhancing efficiency, and create a highly engaged work environment for attracting and retaining highly qualified clinical operations professionals.
Clinical Operations Specialist UCSF Medical CenterClinical Operations SpecialistSan Francisco, CAZion Medical Center (outpatient, including 23-hour stays and the Pain Management Center), Benioff Children''s Hospital Oakland, the UCSF Orthopedic Institute and the Benioff Children''s, Betty Irene Moore Women''s and Bakar Cancer (NIH-designated Cancer Center) Hospitals in the Mission Bay neighborhood. In addition to the Moffitt-Long Hospital, very active units of the department exist at the Zuckerberg San Francisco General Hospital and Trauma Center (inpatient and outpatient, including a very active trauma service), San Francisco Veterans Affairs Medical Center (inpatient and outpatient), Mt.
Associate Clinical Operations Compliance Director (Biotechnology Oncology) Exelixis Inc.Associate Clinical Operations Compliance Director (Biotechnology Oncology)Alameda, CA$168,500–$238,500 / yearThe Associate Clinical Operations Compliance Director is a key partner with our Quality Assurance team and other functional groups (including Clinical Development, Data Management, etc.) and will assist in supporting inspection readiness activities, driving cross-study consistency in study execution and compliance with governing functional procedures and processes, and escalation of identified operational issues within development and of identified quality issues to QA. Bachelor's degree in related discipline and a minimum of 11 years of related experience; or, Master's degree in related discipline and a minimum of 9 years of related experience; or, Doctoral degree in related discipline and a minimum of 5 years of related experience; or, Equivalent combination of education and experience.
Senior Director, Clinical Operations Compliance Management (GCP/Biotechnology/Oncology) Exelixis IncSenior Director, Clinical Operations Compliance Management (GCP/Biotechnology/Oncology)Alameda, CA$246,000–$349,500 / yearThe Senior Director of COCM is a key partner with our Quality Assurance team and other functional groups (including Clinical Development, Data Management, etc.) and is responsible for supporting inspection readiness activities, driving cross-study consistency in study execution and compliance with governing functional procedures and processes, and escalation of identified operational issues within development and of identified quality issues to QA. EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education: Bachelor's degree in related discipline and a minimum of 15 years of related experience; or, Master's degree in related discipline and a minimum of 13 years of related experience; or, Doctoral degree in related discipline and a minimum of 12 years of related experience; or, Equivalent combination of education and experience.
NewDirector, Clinical Operations Rigel Pharmaceuticals, Inc.Director, Clinical OperationsSouth San Francisco, CA$203,000–$245,000 / yearExperience leading global clinical trials across Phase I through Phase III, including responsibility for study planning, start-up, enrollment, monitoring, execution, database readiness, closeout, and Trial Master File oversight. Employees designated as onsite or hybrid who reside within the local commuting area are expected to work onsite at Rigel’s South San Francisco headquarters during normal business hours each Wednesday and Thursday.
Clinical Operations Manager Verily Life Sciences LLCClinical Operations ManagerSan Bruno, CAThe Clinical Operations Manager owns critical study documentation, risk management strategy, site selection and qualification, monitoring oversight, and safety/deviation workflows from study start-up through to study close-out, collaborating within cross-functional teams to drive successful end-to-end study execution. Serve as the primary contact for clinical sites, managing site operations, protocol deviations, adverse event evaluations, and IRB reporting; and, oversees electronic Trial Master Files (eTMFs) to ensure full GCP compliance, regulatory adherence, and continuous audit readiness.
Regional Clinical Operations Manager JumpstartMDRegional Clinical Operations ManagerBurlingame, CaliforniaWe are seeking an individual with a proven track record in multi-site operations leadership, a deep commitment to exceptional member experience, and the leadership instincts to develop and inspire Clinician Managers across our Bay Area region. Are you an experienced operations leader with a passion for healthcare and wellness — someone who thrives in a fast-paced, multi-site environment and knows how to develop great managers, drive results through data, and create a culture of accountability and excellence?
Senior Manager/Director Clinical Operations Lycia Therapeutics IncSenior Manager/Director Clinical OperationsSouth San Francisco, CARemote$180,000–$198,000 / yearAbility to manage in a consensus environment through teamwork, trust and shared expectations, influencing strategic direction of complex global clinical operations issues, solicit information, listen well, persuade others, make important decisions and shape outcomes. Build, develop and train internal staff and external vendors, structure department for enhancing efficiency, and create a highly engaged work environment for attracting and retaining highly qualified clinical operations professionals.
Oversight Director, Clinical Operations Maze Therapeutics IncOversight Director, Clinical OperationsSouth San Francisco, CA$232,000–$283,000 / yearYou will support and develop Study Leads and Clinical Operations team members, establish and oversee CRO and vendor strategies, and maintain accountability for study execution, operational risk management, resource planning, financial oversight, and inspection readiness across your assigned asset. Collaborate closely with Clinical Science, Regulatory Affairs, Data Science, Pharmacovigilance, Biometrics, Medical Monitoring, Clinical Supply, CMC, Tech Ops, Finance, and other cross-functional partners to influence asset strategy and drive successful program execution.
Clinical Research Operations Manager NudgeClinical Research Operations ManagerSan Francisco, CaliforniaWe're starting with an approach that we believe can help the most people the fastest, and also allow us to learn as much about the brain as possible: developing a non-invasive, ultrasound-based device that can stimulate and image the brain at high resolution and depth. We are looking for at least 5 years of directly relevant experience but regardless of your career level, you should have: Experience leading research operations, study operations, program management, or similarly complex interdisciplinary projects.
Director, Clinical Operations Maze Therapeutics IncDirector, Clinical OperationsSouth San Francisco, CA$232,000–$283,000 / yearServe as the operational Study Lead for a global pivotal Phase 3 study (North America, South America, Africa, and Europe), maintaining responsibility for successful execution from protocol development and start-up through enrollment, database lock, study closeout, submission support, and inspection readiness. Maintain a continuous state of inspection readiness across the study, including safety reporting, TMF completeness and quality, essential documentation, evidence of vendor oversight, issue and CAPA management, and audit preparedness, in close partnership with Quality Assurance (QA).
Director, Clinical Operations Iovance Biotherapeutics IncDirector, Clinical OperationsSan Carlos, CARemote$225,000–$240,000 / yearThis will generally involve close supervision of external contract organizations who will have responsibility for site interaction, site monitoring, data management, biostatistics, IRB interaction, central laboratory function, clinical research budget negotiation, medical writing, pharmacovigilance, and other critical activities. In depth knowledge of PC operating systems; Microsoft Office, including MS Word, MS Excel, MS PowerPoint, MS Project, MS Publisher, MS Outlook, and MS Windows NT, Exposure to CTM systems, EDC systems (eClinical, Medidata RAVE, InForm) and Safety/ Pharmacovigilance databases (ARGUS).
Senior Clinical Quality Operations Manager Eikon Therapeutics IncSenior Clinical Quality Operations ManagerMillbrae, CA$157,000–$189,000 / yearThis includes ensuring consistent execution of quality-by-design (QBD) principles across assigned clinical development programs and facilitating identification of Critical to Quality (CtQs) factors and associated risk assessments, establishing, and actively maintaining study-specific quality plans throughout the study lifecycle using a risk-based approach. In partnership with the Director of Process Management for Clinical R&D, the Head of Clinical Data Analytics and Reporting and the Head of Clinical Study Management, builds proficiency in leveraging technology and data to recognize and respond to new and emerging risks across the clinical portfolio, including how GCP applies to digital data management and novel trial technology.
Clinical Operations Lead Convergent ResearchClinical Operations LeadSan Francisco, CAFull timeNice to have: background in neuroscience, neuroimaging, neuromodulation; work with hospitals, academic medical centers, or external clinical research partners; early-stage medical device or biotech experience; familiarity with ICH-GCP, ISO 14155, and FDA medical device requirements; experience with QMS, CTMS, or eTMF systems; AE/SAE reporting, monitoring, CAPAs, and audit readiness. Build the clinical program: Partner with scientific leadership on clinical strategy: which sites and partnerships and where our incentives align.
Oversight Director, Clinical Operations Maze TherapeuticsOversight Director, Clinical OperationsSouth San Francisco, CA$232,000–$283,000 / yearYou will support and develop Study Leads and Clinical Operations team members, establish and oversee CRO and vendor strategies, and maintain accountability for study execution, operational risk management, resource planning, financial oversight, and inspection readiness across your assigned asset. Collaborate closely with Clinical Science, Regulatory Affairs, Data Science, Pharmacovigilance, Biometrics, Medical Monitoring, Clinical Supply, CMC, Tech Ops, Finance, and other cross-functional partners to influence asset strategy and drive successful program execution.
Director, Clinical Operations Maze TherapeuticsDirector, Clinical OperationsSouth San Francisco, CA$232,000–$283,000 / yearServe as the operational Study Lead for a global pivotal Phase 3 study (North America, South America, Africa, and Europe), maintaining responsibility for successful execution from protocol development and start-up through enrollment, database lock, study closeout, submission support, and inspection readiness. Maintain a continuous state of inspection readiness across the study, including safety reporting, TMF completeness and quality, essential documentation, evidence of vendor oversight, issue and CAPA management, and audit preparedness, in close partnership with Quality Assurance (QA).