Senior Manager/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology) Nurix Therapeutics, Inc.Senior Manager/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology)Brisbane, CA$187,800–$208,638 / yearWorks strategically with all regulatory functions to develop detailed, actionable submission plans, tracks major submission deliverables, and ensures consistent management submission documents, health authority communications, and all other regulatory information supporting Nurix's investigational and marketing applications. Job Summary: In this role, you will be a core member of the Regulatory team and will be responsible for helping build and execute on global regulatory strategy, objectives, policies and programs pertaining to development and future marketing of products.
Associate Director, Clinical Trial Operations Nkarta, Inc.Associate Director, Clinical Trial OperationsSouth San Francisco, CA$190,000–$230,000 / yearDevelop, review, and approve clinical study plans, manuals, presentations, and other study documents (country/site specific ICF's, site facing documents and tracking tools), assist with user acceptance testing, sample and product tracking, and other activities as needed. While getting better work-life balance and improving communications between groups in an early stage start up environment are two areas on which we are working, here are real, anonymous comments about or regarding why people think Nkarta is a great place to work.
Clinical Director Pacific ClinicsClinical DirectorSan Jose, California$116,889–$143,759 / yearMaster's Degree in Social Work, Marriage and Family Counseling, Psychology, or related field and five (5) or more years direct clinical experience, or equivalent combination of education and experience (two years of relevant experience equals one year of education) to include: Three years in the area of adult's and children's mental health and three (3) years of clinical supervisory experience, California licensure as LCSW, LMFT, Ph. SBIT services are delivered within a Multi-Tiered Systems of Support (MTSS), with a focus on Positive Behavioral Intervention Supports (PBIS), Wellness Center implementation, Social Emotional Learning, Restorative Practices, various evidence-based practices to support Community School efforts.
Clinical Program Supervisor Community SolutionsClinical Program SupervisorSan Jose, CaliforniaThe Clinical Program Supervisor will work collaboratively in a multi-disciplinary team, that includes clinical staff, psychiatrists, management, direct care staff, and senior leadership, to review clients’ treatment progress and facilitate excellent treatment planning, as well as working closely with the Program Manager to lead initiatives that lead to improving client care to meet agency and program goals. POSITION TITLE: Clinical Program Supervisor JOB TYPE: Regular, Full-Time, Exempt, Non-Union, Benefitted PROGRAM: Adult/Older Adult Outpatient Continuum REPORTING RELATIONSHIP: Program Manager SUMMARY: Under the general supervision of the Program Manager, the Clinical Program Supervisor is responsible for the collaboration and oversight of day-to-day operation of assigned program and direct supervision of assigned staff.
Field Clinical Specialist- Shockwave Medical (Colorado / Wyoming) Johnson & JohnsonField Clinical Specialist- Shockwave Medical (Colorado / Wyoming)Santa Clara, CARequired Skills: Preferred Skills: Business Behavior, Communication, Consulting, Cross-Selling, Customer Centricity, Customer Effort Score, Customer Retentions, Execution Focus, Goal Attainment, Hospital Operations, Innovation, Market Research, Medicines and Device Development and Regulation, Sales, Solutions Selling, Sustainable Procurement, Vendor Selection. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Associate Director, Clinical Data Management Thorough GroupAssociate Director, Clinical Data ManagementRedwood City, CaliforniaThis individual will play a key leadership role in ensuring the quality, integrity, and accessibility of clinical trial data while partnering closely with Clinical Operations, Biometrics, Pharmacovigilance, Regulatory Affairs, and external vendors. As the organization continues to grow, they are seeking an experienced Associate Director, Clinical Data Management to lead data management strategy and execution across multiple clinical development programs.
Associate Director, Clinical Supply Chain Ideaya Biosciences IncAssociate Director, Clinical Supply ChainSouth San Francisco, CA$167,000–$206,000 / yearThe essential responsibilities of Associate Director include (but not limited to) clinical trial supply management, vendor management, oversight of external partners including depots and Contract packaging Organizations to ensure robust and compliant supply chain for all IDEAYA's programs and in accordance with applicable laws and regulations. What you'll do: Clinical Supply Management (General): Assist with identification and management of external global partners (e.g., depots, couriers, CMOs, IRT vendors) to ensure availability of drug supply at depots/clinical trial sites.
Associate Director, Clinical Trial Operations Nkarta IncAssociate Director, Clinical Trial OperationsSouth San Francisco, CA$190,000–$230,000 / yearDevelop, review, and approve clinical study plans, manuals, presentations, and other study documents (country/site specific ICF's, site facing documents and tracking tools), assist with user acceptance testing, sample and product tracking, and other activities as needed. While getting better work-life balance and improving communications between groups in an early stage start up environment are two areas on which we are working, here are real, anonymous comments about or regarding why people think Nkarta is a great place to work.
Executive Director, Translational Science & Clinical Biomarkers Adicet Bio, Inc.Executive Director, Translational Science & Clinical BiomarkersRedwood City, CAThe Executive Director will guide the design and implementation of clinical biomarker approaches to inform mechanism of action, pharmacokinetics, pharmacodynamics, patient selection, and clinical decision-making, supporting product candidates through first-in-human and subsequent clinical trials in close collaboration with cross-functional teams. This individual will define and lead integrated translational and clinical biomarker strategies across the portfolio, enabling the successful translation of novel cell therapy programs from preclinical research into clinical studies.
Virtual Clinical Outreach Sales OCD Anxiety CentersVirtual Clinical Outreach SalesPleasanton, CAInside sales, inside sales outreach, provider relationship building, prospecting, referral source development, clinical service education, admissions growth, Salesforce documentation, Microsoft Word and Excel, ZoomInfo drip campaigns, virtual meetings, phone and email follow-up, objection handling, account management, territory planning, and cross-functional collaboration. Meet with providers via Teams to educate them on OCD Anxiety Centers, outcomes, success stories, the referral process, recognizing OCD themes, ERP, admission criteria, insurance acceptance, clinical outcomes, and Virtual IOP services.
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).
Clinical Specialist - California - IHFM Edwards LifesciencesClinical Specialist - California - IHFMSan Jose, CA$106,000–$125,000 / yearModerate knowledge and understanding of the following areas including valve crimping, case management, pre-case planning, post case management, Therapy Awareness Program management, and clinical education programs. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention.
Clinical Scientist Intuitive Surgical IncClinical ScientistSunnyvale, CAThe purpose of this job is to work collaboratively to develop strategies for the creation of CEPs followed by the development of CERs per EU MDR, to meet essential requirements in support of submission for CE Mark application to obtain Declaration of Conformity and EU market clearance, re-certification, and proposed indication/labeling changes. Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process).
Clinical Data Engineer II/III ClearNote Health IncClinical Data Engineer II/IIISan Mateo, CA$150,000–$190,000 / yearPosition Summary: The Clinical Data Engineer II/III owns clinical Data Operations: the data pipelines, data warehouse, and reporting infrastructure that transform clinical data, laboratory data, and sequencing results into validated, audit-ready clinical and business data. Leveraging its novel liquid biopsy technology, ClearNote Health is initially focused on high-mortality cancers with the greatest need for early detection, starting with pancreatic and ovarian cancers.
Senior Clinical Trial Manager Sr CTM Corcept Therapeutics IncSenior Clinical Trial Manager Sr CTMRedwood City, CA$170,500–$200,700 / yearThis leader will work with cross-functional teams as well as vendors, clinical sites, and CROs to execute protocol requirements to ensure study deliverables, milestones, and objectives are met within timelines and budget. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today.
Senior Clinical Trial Manager (Sr CTM) Corcept TherapeuticsSenior Clinical Trial Manager (Sr CTM)Redwood City, California$170,500–$200,700 / yearThis leader will work with cross-functional teams as well as vendors, clinical sites, and CROs to execute protocol requirements to ensure study deliverables, milestones, and objectives are met within timelines and budget. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today.
Clinical Social Worker Mass General BrighamClinical Social WorkerBelmont, CaliforniaClass D Passenger Vehicle Driver's License [State License] - Generic - HR Only preferred Licensed Clinical Social Worker [LCSW - State License] - Generic - HR Only preferred Licensed Independent Clinical Social Worker [LICSW - State License] - Generic - HR Only preferred. In addition to these core responsibilities, the LICSW will assist with research-related activities, including patient education about clinical studies procedures, integration of psychosocial insights into study workflows, coordination of research-related study visits, and accurate documentation of behavioral health data.
Clinical Staff Pharmacist, Inpatient - McLean Hospital Mass General BrighamClinical Staff Pharmacist, Inpatient - McLean HospitalBelmont, CaliforniaThe team member ensures optimal clinical care in the acute and residential/partial psychiatric setting, which includes aspects of general medicine, through assessment of patient-specific factors and collaboration with other healthcare professionals. Clinical staff pharmacists also partake in clinical initiatives/services, inventory management, educational activities, hospital/department committees, and continuous quality improvement as assigned.
Vice President (VP) / Senior VP, Clinical Development Lycia Therapeutics IncVice President (VP) / Senior VP, Clinical DevelopmentSouth San Francisco, CA$360,000–$420,000 / yearCollaboration with the Lycia Executive Committee members, early development / translational medicine leader, internal cross functional team members, as well as partner with contract research organizations (CROs), investigators and study site staff, and external consultants to advance multiple drug candidates, including into mid- and late-stage development. Provide medical support related to the development of medical and/or relevant scientific sections of clinical study and/or regulatory documents (e.g., study protocol, investigators brochure, informed consent forms, clinical study reports, statistical analysis plans, safety updates / annual safety reports, responses to Health Authorities and/or Ethics Committees / Institutional Review Committees).
Director, Clinical Data Management Revolution Medicines, Inc.Director, Clinical Data ManagementRedwood City, CA$211,000–$264,000 / yearProvides CDM oversight of outsourced and partner-resourced clinical trials including scoping trials, project management, relationship management, approval of deliverables, and coordination of internal reviewers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS.