Trabajos clinical trial en San Diego, California - Page 2Crear alertas

Client Partner – Life Sciences Location: San Diego, CA (Hybrid) Type: Full-time Are you an Engagement Manager, Client Executive, or Account Director with a strong background in life sciences consulting - and looking for the next step in your career? iO Associates are supporting a leading consultancy driving data, AI/ML, and cloud-led innovation across pharma and biotech. We’re now hiring a Client Partner in San Diego to expand strategic accounts and shape data-driven transformation across R&D, Clinical, Manufacturing, and Commercial functions. What you’ll be doing • Leading and growing strategic client accounts, • Advising senior executives (CIOs, Heads of R&D, Commercial leaders), • Partnering with solution architects and delivery teams on cloud, AI/ML, and advanced analytics solutions, • Shaping transformation initiatives in clinical trial optimisation, patient analytics, manufacturing, and regulatory What we’re looking for • Consulting or IT services background with a focus on life sciences, • Proven experience in client engagement, account management, or business development, • Technical understanding of cloud platforms (AWS, Azure, GCP) and analytics, • Strong relationship-building skills and commercial acumen 📍 Location: Hybrid role based in San Diego 🚀 Career Progression: An excellent chance for someone operating at the Engagement Manager / Client Executive level to step into a Client Partner leadership role 👉 Apply today to accelerate your career in life sciences consulting.

Must have at least 1.5 years of independent monitoring experience • Works on Immunology/ multi TA Clinical Trials, • Quality of life focus with Regional Travel, • Demonstrated leadership, through involvement in specific initiatives when needed, and/or SME to systems and/or processes • Mentors/coaches junior flex team, • Acts as Lead SM-training other SMs on study, • Develops site start up documents for studies including SIV agenda, • Provides SM “voice” when reviewing study documents (e.g. Monitoring Guidelines), • Represents LTMs or SMs on SMTs/meetings, • Takes over LTM role reports review (SQV, SMV, SCV) for sites assigned to other SMs from the same trial, • Supports country budget development and/or contract negotiation in liaison with CCS colleagues, • Assists with ASV, • Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

We are working with a mid-sized biotech company that works with cell and immunotherapy products which are designed to help strengthen the immune system of patients in need. Some of their specialty areas include Immunotherapy, Oncology, Cell Therapy, and much more as they are proactively expanding their sciences. The client is looking for a Sr GCP Auditor who is well seasoned with auditing in the clinical space (more specifically in CROs and investigator sites). Essential Functions: • Maintain and update the Clinical Trial Quality Management system to be current with industry standards, guidance, and best practices., • Contributes to the development and review of SOPs and other controlled documents (forms, templates, work instructions)., • Ensures compliance with SOPs and ICH GCP E6 (R2) standards., • Schedules, plans, coordinates, and conducts vendor/supplier audits, internal audits, compliance visits, for cause audits and clinical trial site audits, • Prepares required documentation to support audit activities including audit plans, audit reports, audit certificates and corrective action plans, • Participate in solving GCP compliance issues within Quality Assurance, Clinical Operations, Regulatory Affairs, Medical Affairs, and Pharmacovigilance. Skill Requirements: • Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines, • Strong problem solving and analytical skills with demonstrated ability to be detail-oriented, while managing multiple projects simultaneously., • Demonstrated understanding and application of ICH GCP E6 (R2), • Timeline focused and flexible in their work scheduling to meet the demands of a multi-product clinical phase pharmaceutical company. If you have extensive with GCP auditing in the pharma/biotech industry and feel that you'd be a good fit for this role based on the requirements listed, please apply!

Vivo HealthStaff is recruiting for a Clinical Trials Physician for a Vaccine Trial in the USA. We are seeking an experienced and licensed Pain Management Physician to provide locum tenens coverage at multiple clinic locations across the USA. The ideal candidate is board certified, has a current medical license, and is looking for contract work. Position Details: Specialty: Clinical Trials Start Date: Flexible Based on Availability Contract Length: 3-12 months, with extension potential Schedule: 1-2 days per week Call: No call required Practice Setting: Outpatient clinic Locations Available: * Washington DC * San Diego, CA * Denver, CO * San Jose, CA Responsibilities: * Evaluate patients for a vaccine trial * Collaborate with clinic staff and specialists for comprehensive clinical trial * Use EMR for documentation Requirements: * Active and unrestricted Medical License * Active DEA registration * Prior experience in Clinical Trials Compensation & Benefits: Pay Rate: Competitive hourly rate Payment: Weekly direct deposit Insurance: Malpractice insurance provided Support: Dedicated recruiter assistance throughout the assignment Onboarding Process: Expedited credentialing available Assistance with compliance and facility paperwork Orientation provided before the start date About Vivo HealthStaff: Vivo HealthStaff is a locum tenens staffing firm specializing in placing healthcare professionals in temporary and long-term assignments across the United States. We are committed to providing seamless placement experiences for providers and healthcare organizations.

Job Description Invivoscribe is an industry pioneer, dedicated to Improving Lives with Precision Diagnostics®. Invivoscribe has been the global leader in driving international standardization of testing and accelerating patient access to the newest and best cancer treatments for over 25 years. Headquartered in sunny San Diego, California with locations across the world, we offer a comprehensive portfolio of products and services. We work with key collaborators to develop molecular assays, reagents, controls and bioinformatics tools under ISO 13485 design control that are used by over 700 clinical laboratories in over 160 countries. Our global network of laboratories offers internationally standardized next generation molecular and flow cytometry panels to support drug development and accelerate drug approvals worldwide. We work with pharmaceutical partners and international regulatory agencies across the globe to develop companion diagnostics, which are necessary to gain approval of new drugs and treatments for cancer patients. Our harmonized ISO15189 accredited and CLIA/CAP clinical laboratories offer a test menu focused on biomarkers which are clinically actionable to support therapeutic decisions, measurable residual disease (MRD) testing, patient stratification, and trial enrollment, all designed to accelerate approvals of new oncology drugs and treatments. For 25 years, we have been at forefront of precision diagnostics, and we’re just getting started! We are looking to add a Senior Customer Support Specialist. S/he maintains direct contact with customers before and/or after the sale. S/he develops and maintains positive customer relations with clients/customers, which can substantially affect service and/or product revenue(s). Core Responsibilities Include: • Receives and responds to customer calls; provides answers to basic inquiries such as products sold, shipping dates, back orders, pricing and availability. Receives and responds to customer calls for LabPMM providing answers to inquiries such as test results and test look up., • Directs the customer to the employee most appropriate to answer their inquiry, such as technical support for product performance questions., • Escalates satisfaction issues as appropriate., • Accepts and processes orders received via mail, email, phone, or fax in a timely manner. Accurately processes and correctly verifies orders., • Performs data entry and special handling of high-level account orders into the ERP database system, checking product information, availability, and the status of the shipments., • Ensures product delivery in accordance with customer requirements and manufacturing capabilities. Investigates problems related to shipment of products, credits and new orders., • Closely tracks status of orders & shipments, such as monitoring account set up, coordinate with site (sponsor, CRO) any required documentation for shipments, etc., closely monitors the status of outbound shipments., • Prepares shipping documentation for international shipments, which do not use FedEx as the shipping carrier and ensures that these shipments are shipped in accordance with controlled procedures and product requirements. Ensures international shipments meet all the export requirements and procedures, including electronic submission of EEI via AES shipment with commercial invoices., • Assists in generating quotes requested by Customers and Account Managers., • Distributes literature/materials in response to inquiries, as necessary., • Performs tracking of various spreadsheets for quality and performance improvement., • Assists in creating and implementing process documents., • Assists in training newly hired team members., • High School Diploma and, typically, 4+ year(s) of applicable experience in a life science FDA regulated industry. A.S. degree or equivalent college coursework, trade school and/or applicable certification is advantageous. Equivalent combination of education and experience will be considered., • A beautiful modern facility centrally located in San Diego County, with many jobs conducive to flexible scheduling and telework options., • A welcoming breakroom for gathering with hosted hot/cold beverages and healthy convenience foods, and an available micro-market to get you through the day., • A positive workplace culture with an emphasis on support, respect and belonging., • A diverse and inclusive work environment where you will learn, grow, and make new friends., • Competitive pay, discretionary bonus program, incentive stock options, generous benefit options, 401k with a fully vested employer match, and generous time off benefits. Invivoscribe is an Equal Opportunity Employer.

Establish and maintain strong relationships with internal cross-functional teams, vendors and clinical research site personnel for successful execution of clinical trial. Responsibilities: Clinical Data Manager, providing oversight to ensure complete, accurate and high-quality data collection for ou

The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Knowledge of other software: Visio. Bachelor's degree with at least 10 years of related clinical trial supply experience wi

The ideal candidate will serve as the primary recruitment and retention project manager for one or more of the various studies conducted at ATRI under the supervision of the RER operations manager and the oversight of the RER section faculty lead for the study. Clinical Trial Participant Recruitment

BS/BA degree and 6+ years of clinical trial management experience, including CRO/vendor management (domestic and international), monitoring of budget scope, clinical site monitoring or related experience required OR. Serves as primary point of contact for clinical operations aspects of assigned clin

Clinical Research Associate II will participate in clinical research teams to ensure the most effective and efficient conduct of clinical research studies by providing training, protocol interpretation, document collection and review and overall clinical trial support. Bachelor's degree in a clinica

This position will work closely with Clinical Operations & Development, Biometrics, and IT teams to develop and optimize data pipelines, integrate various clinical systems, and deliver analytical solutions that enable data-driven decision-making throughout the clinical trial lifecycle. Support the c

Job Description POSITION SUMMARY: Performs study-related clinical procedures according to the study protocol and provides care under appropriate supervision for subjects enrolled in clinical trials. Performs duties in accordance with ProSciento’s values, policies, and procedures. DUTIES AND RESPONSIBILITIES: • Understands the main objectives of each ongoing study and the study procedures for which he/she will be responsible., • Demonstrates proficiency at performing basic clinical procedures such as vital signs, ECGs, phlebotomy, and sample processing., • Demonstrates proficiency in documenting observations and study procedures correctly and legibly in the source document., • Understands and demonstrates proficiency in appropriately responding to medical emergencies onsite., • Performs study procedures as assigned., • Observes and records data related to patient safety and study procedures., • Ensures that all study data is recorded accurately and completely., • Assists nursing staff and Clinical Project Managers with study procedures and patient management as directed., • Assists in the transcription of study data from source documents to Case Report Forms (CRFs)/ (eCRFs)., • Understands and complies with Good Clinical Practices (GCPs), particularly those regarding the protection of human subjects and integrity of clinical trial data., • Understands and complies with ProSciento Standard Operating Procedures (SOPs) and Work Instructions (WIs)., • Participates as requested in ProSciento Continuous Quality Improvement (CQI) process., • Flexibility to work mornings, evenings, and/or overnight shifts as needed., • Attends and participates in all required training activities., • Participates as requested as a Clinical Operations Study Liaison., • Assists with Screening Receptionist duties and responsibilities as requested., • Assists with Recruitment duties and responsibilities as requested. JOB REQUIREMENTS / QUALIFICATIONS/EDUCATION: Qualifications: To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education and Experience: High school diploma or general education degree (GED) as well as experience as a Medical Assistant, EMT, LVN, Phlebotomist, Foreign Medical Graduate (FMG), or Corpsman in a clinical or laboratory setting and/or equivalent combination of medical education, training, certifications, and/or experience. KNOWLEDGE, SKILLS, AND COMPETENCIES REQUIRED Skills, Knowledge, and Abilities: Able to perform basic clinical procedures correctly including vital signs, ECGs, and sample processing. Demonstrates initiative and problem-solving skills. Able to respect subject confidentiality and blinding procedures. Understands medical terminology and calculations. Demonstrates a strong attention to detail with superior organizational skills. Under general supervision, exercises judgment in accordance with well-defined policies, procedures, and techniques. Able to self-monitor progress and complete assigned tasks independently. Competencies: • Functional/Technical Skills: Has the functional and technical knowledge and skills to do the job at a high level of accomplishment., • Peer Relationships: Can quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers., • Process Management: Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient workflow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can’t; can simplify complex processes; gets more out of fewer resources., • Action Oriented: Enjoys working hard; is action oriented and full of energy for the things he/she sees as challenging; not fearful of acting with a minimum of planning; seizes more opportunities than others., • Basic Life Support (BLS) certification is required and may be provided by the company. GCP training is required and will be provided by the company. Language Skills: • Must be proficient in both verbal and written English. Able to communicate effectively with both employees and management. Ability to read and interpret documents such as safety rules, WIs, SOPs, medical terminology, and procedure manuals. Math Skills: • Able to add, subtract, multiply, and divide in all units of measure using whole numbers, fractions and decimals. Able to compute rate, ratio, and percent and to draw and interpret bar graphs. Reasoning Skills: • Ability to apply common sense understanding to carry out instructions provided in written, oral or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. Computer Skills: This role is a part-time, non-benefited role.

Job Description:\n\n In San Diego, the starting hourly base rate for Team Jeni's Team Leaders is $20.50/hour but our Team Leaders have the opportunity to earn an average of $30.96 per hour!* *This is an estimate of hourly earnings. It is based on the 2025 base pay rate, plus 2024's hourly tip average. 2025 actual customer tips may vary. Jeni’s Splendid Ice Creams is searching for part-time Team Leaders to join our North Park team. At Jeni’s, we’re devoted to making better ice creams and bringing people together. Our scoop shops are at the heart of how we serve this mission. They are where we offer the ice creams we work so hard to build from the ground up—where people come together to share joy and conversation. We love people. We love ice cream. We view ice cream as a form of art. Team Jeni’s Team Leaders are part-time crew members who lead shifts. In addition to leading shifts, they scoop and serve ice cream to our customers, make waffle products, run the register with cash management responsibilities, keep the shop clean, change out buckets of ice cream, and perform a number of other important, related tasks. As a Team Leader, you will: Serve the ice cream Time magazine calls “the best in America” Gain valuable real-world business and entrepreneurship experience Work in an environment oriented around serving each other and making people’s day Lead shifts and act as a role model for other team members Have opportunities for growth within a growing company Receive competitive compensation Qualities of Team Leaders: Exhibit passion for community, an eye for detail, a willingness to clean (a lot), stamina (to serve people in long lines), and the ability to work in a fast-paced environment The ability to positively influence and lead a shift of ambassadors, helping them uphold the highest standards and feel supported Resourceful and calm when challenges come up Have great judgment, common sense, and be skillful interpersonally Familiar with (and be able to articulate to customers) what distinguishes Jeni’s Splendid Ice Creams from other ice creams, and be able to articulate that to the 500th customer with the same care and presence as the 1st customer Available to work weekends, late nights (past 11 p.m.) Provide consistent, world-class service to every single customer Reliable, on time, and ready to hustle for every shift Committed to the well-being of their shop team, their community, and the environment around them About Jeni’s Splendid Ice Creams: Founded by Jeni Britton in 2002, Jeni's Splendid Ice Creams is a certified B Corp headquartered in Columbus, Ohio, with scoop shops in over twenty cities across the country, making it possible for members of Team Jeni’s who are interested in developing their careers, or transitioning to a new city, to have meaningful opportunities to learn, grow, and explore. Our Team Leaders make a difference in their shop, their community, and in how they partner with their team and serve their customers. If this opportunity sounds delicious to you, please apply. Jeni's is an equal opportunity employer. Said our way, we love and honor differences, and we love sharing common values such as talent, hustle, guts, resilience, and empathy. Our differences are a primary source of our team's strength and we crave having a team rich with diversity which is creativity and art in its human form. ___ NOTICE PURSUANT TO THE CALIFORNIA CONSUMER PRIVACY ACT AND CALIFORNIA PRIVACY RIGHTS ACT Effective Date: July 1, 2020 Last Reviewed on: December 7, 2023 Introduction This Privacy Notice (the “Privacy Notice”) is adopted to comply with the California Consumer Privacy Act of 2018 as amended by the California Privacy Rights Act of 2020 (“CCPA”). Any terms defined in the CCPA have the same meaning when used in this Privacy Notice. Jeni’s Splendid Ice Creams, LLC (“Jeni’s”) is committed to protecting the privacy and security of personal information. In the course of our business, we may ask job applicants, prospective employees and employees (“you” or “your”) to provide personal information relating to your employment or prospective employment. This Privacy Notice describes how Jeni’s collects and uses personal information, the categories of personal information we collect and instances when the personal information may be disclosed to third parties. Jeni’s will only collect and process personal information in accordance with this Privacy Notice, unless otherwise required or permitted by applicable law. Information We Collect We collect information that identifies, relates to, describes, references, is reasonably capable of being associated with, or could reasonably be linked, directly or indirectly, with a particular individual ("Personal Information"). Further, under California law certain data elements are classified as Sensitive Personal Information (“SPI”). Collection of such data provides possible additional rights to California employees (see Your California Privacy Rights). Below is a list of data elements that are classified as SPI:  Identifying Information: SSN, Driver’s license number, passport/visa information, immigration information  Demographic data: Race, ethnic origin  Financial Information: Banking details  Health and safety information: Employment-relevant health conditions, workplace illness  IS information: contents of user’s mail, email, or text messages  Biometric Information: Facial recognition scans, fingerprints, iris/retina scans, and keystroke or other physical patterns  Geolocation Data: Precise physical location  Other SPI: religious/philosophical beliefs, union membership, sexual orientation, credit card number/access code, genetic data Personal Information does not include:  Publicly available information from government records.  Deidentified or aggregated consumer information.  Information excluded from the CCPA’s scope, like: o Health or medical information covered by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the California Confidentiality of Medical Information Act (CMIA) or clinical trial data; o Personal Information covered by certain sector-specific privacy laws, including the Fair Credit Reporting Act (FCRA), the Gramm-Leach-Bliley Act (GLBA) or California Financial Information Privacy Act (FIPA), and the Driver's Privacy Protection Act of 1994. Jeni’s has and may continue to collect the following categories of personal information from employees, applicants and contractors for the purposes stated below, as well as the following purposes: efforts to recruit employees, administration of benefits, paying and reimbursing expenses, managing your employment relationship with us, conducting performance related reviews, accounting and human resource services, assisting in case of emergency, monitoring eligibility to work in the U.S., ensuring a safe and efficient working environment, facilitating a better working environment, maintaining security, and compliance with applicable laws and regulatory requirements, conducting internal audits and workplace investigations, investigating and enforcing compliance with and potential breaches of Jeni’s policies and procedures, engage in corporate transactions requiring the review of employee records, maintaining commercial insurance policies and coverages:  Pre-Hire Documents: job application and/or resume, cover letter with salary requirements, prior employment history, education information, background check information, drug test information, job interview notes, candidate evaluation records, written recommendations or notes from reference interviews. This information is collected for the above stated purposes and to comply with local, state and federal law requiring employers to maintain such records, to effectively hire qualified candidates, etc. and to assess qualifications for a particular job or tax, conduct performance reviews and determine performance requirements. Jeni’s will not collect additional categories of personal information or use the personal information collected for materially different, unrelated, or incompatible purposes without first providing you with additional and/or updated notice. We do not share your personal information as defined under Cal. Civ. Cd. 1798.140(ah). Disclosure to Third Parties Jeni’s does not sell or otherwise disclose your personal information to any third parties for any monetary consideration. Jeni’s only shares your personal information with service providers to the extent necessary in order to administer employee benefits, including for payment of wages, tax processing, and health insurance, and in connection with its human resource activities. Jeni’s also discloses your information when required by local, state, or federal law. Retention Schedule We will retain your personal information for no longer than is necessary for the purposes noted above, unless otherwise extending the retention period is required or permitted by law or subject to our retention policies as may be in place from time to time. Your Rights and Choices Under California Law The CCPA provides California employees with specific rights regarding their personal information. This section describes CCPA rights and explains how to exercise those rights. Access to Specific Information and Data Portability Rights You have the right to request that we disclose certain information to you about our collection and use of your personal information over the past 12 months. Once we receive and confirm your verifiable consumer request, we will disclose to you:  The categories of personal information we collected about you.  The categories of sources for the personal information we collected about you.  Our business or commercial purpose for collecting or selling that personal information.  The categories of third parties with whom we share that personal information.  The specific pieces of personal information we collected about you (also called a data portability request).  If we disclosed your personal information for a business purpose, a list of the disclosures made identifying the personal information categories that each category of recipient obtained. Correct/Rectify Personal Information You have the right to rectify (correct, update, or modify) the personal information we collect about you. After making such a request, we will take commercially reasonable efforts to correct inaccurate personal information within 45 days of receiving the request. In the event an extension is needed, we may take an additional 45 days when reasonably necessary. In this case, We will provide you a notice of extension within the first 45-day period. Deletion Request Rights You have the right to request that we delete any of your personal information that we collected from you and retained, subject to certain exceptions. Once we receive and confirm your verifiable consumer request, we will delete (and direct our service providers to delete) your personal information from our records unless an exception applies. We may deny your deletion request if retaining the information is necessary for us or our service providers to:  Fully carry out your relationship with us as an employee or job applicant  Detect security incidents, protect against malicious, deceptive, fraudulent or illegal activity, or prosecute those responsible for such activities.  Debug products to identify and repair errors that impair existing intended functionality.  Exercise free speech, ensure the right of another consumer to exercise their free speech rights or exercise another right provided for by law.  Comply with the California Electronic Communications Privacy Act (Cal. Penal Code § 1546 seq.).  Engage in public or peer-reviewed scientific, historical or statistical research in the public interest that adheres to all other applicable ethics and privacy laws, specifically if you previously provided informed consent and deleting that information may seriously impair or render impossible the research’s achievement.  Enable solely internal uses that are reasonably aligned with consumer expectations based on your relationship with us.  Comply with a legal obligation.  Make other internal and lawful uses of personal information that are compatible with the context in which you provided it. Exercising Access, Rectification, Data Portability, and Deletion Rights To exercise the access, rectification, data portability and deletion rights described above, please submit a verifiable request to us by either:  Calling us at 614.360.2565  Via Email at . You may only make a verifiable consumer request for access or data portability twice within a 12-month period. The verifiable consumer request must:  Provide sufficient information that allows us to reasonably verify you are the person about whom we collected personal information or an authorized representative.  Describe your request with sufficient detail that allows us to properly understand, evaluate and respond to it. We cannot respond to your request or provide you with personal information if we cannot verify your identity or authority to make the request and confirm the personal information relates to you. Making a verifiable consumer request does not require you to create an account with us. We will only use personal information provided in a verifiable consumer request to verify the requestor’s identity or authority to make the request. Response Timing and Format Per CCPA requirements, we will confirm receipt of a consumer’s request within 10 days. We will try our best to respond to a verifiable consumer request within 45 days of its receipt. If we require more time (up to 90 days), we will inform you of the reason and extension period in writing. We will deliver our written response by mail or electronically, at your option. Any disclosures we provide will only cover the 12-month period preceding the receipt of the verifiable consumer request’s receipt. The response we provide will also explain the reasons we cannot comply with a request, if applicable. For data portability requests, we will select a format to provide your personal information that is readily useable and should allow you to transmit the information from one entity to another and should allow you to further transmit information if you desire. We do not charge a fee to process or respond to your verifiable consumer request unless it is excessive, repetitive or unfounded. If we determine that the request warrants a fee, we will tell you why we made that decision and provide you with a cost estimate before completing your request. Non-Discrimination We will not discriminate against you for exercising any of your CCPA rights. Based solely on the exercise of your CCPA rights. Changes to This Privacy Notice Jeni’s reserves the right to update this Privacy Notice at any time and

Job Description Kenai Therapeutics (Kenai) is a biotechnology company pioneering next generation approaches to cure neurological conditions. The Company utilizes induced pluripotent stem cell (iPSC) technology, a Nobel Prize-winning breakthrough that enables scientists to manufacture any human cell, to generate Kenai’s off-the-shelf neuron replacement therapeutics. By focusing on an iPSC technology platform, and forging partnerships with global leaders in surgical delivery and clinical development, Kenai is dedicated to advancing a best-in-class pipeline targeting neurological conditions. Kenai Therapeutics closed an $82 million Series A financing in 2024, co-led by Alaska Permanent Fund Corporation, Cure Ventures and The Column Group, with participation from Euclidean Capital and Saisei Ventures. Reporting to the Chief Medical Officer (CMO), the Vice President of Clinical Operations is a senior leadership position responsible for overseeing and advancing all clinical operations activities across the organization. This role will serve as the strategic and operational leader, ensuring the successful execution of clinical trials, with a focus on meeting project milestones, timelines, and regulatory requirements. The VP of Clinical Operations will collaborate closely with executive leadership, functional heads, and external stakeholders to drive the clinical program's success, from early-phase trials through post-marketing surveillance. Responsibilities Strategic Leadership: • Develop and execute clinical operations strategies to support company objectives and ensure alignment with the broader business goals., • Lead the planning, design, and execution of clinical trials, ensuring adherence to timelines, budgets, regulatory standards (GCP/ICH), and quality expectations., • Develop resourcing strategies to support clinical program needs, ensuring adequate and efficient allocation of resources for both internal and outsourced activities., • Lead and collaborate with other functional areas, including Regulatory Affairs, Medical Affairs, Biometrics, and Research, to ensure integration of project goals and efficient execution of clinical programs., • Serve as a key representative of Clinical Operations in interactions with external stakeholders, including KOLs, patient advocacy groups, regulatory agencies, and vendors., • Oversee the clinical trial budgets, resource allocation, and financial forecasting, ensuring projects are delivered on time and within budget., • Provide regular updates to executive management on the status of ongoing clinical programs and trials., • Regulatory Compliance & Safety:, • Ensure that all clinical trials comply with applicable regulatory guidelines, including FDA, EMA, and ICH standards., • Lead, mentor, and develop a high-performing Clinical Operations team, providing coaching, training, and career development opportunities., • Foster a culture of collaboration, quality, and excellence within Clinical Operations and across the organization. Qualifications • REQUIRED: Experience in cell and gene therapy, deployed for interventional studies in the nervous system, • Minimum 15 years of experience in clinical operations, with at least 10 years in leadership roles within the pharmaceutical or biotechnology industry., • A bachelor’s degree in life sciences (or related field) is required; an advanced degree (e.g., MBA, PhD) is preferred., • Proven experience in managing both early-phase and late-phase clinical trials, including vendor management and outsourcing., • Strong understanding of regulatory requirements (FDA, EMA, ICH), GCP, and clinical trial design., • Demonstrated success in building and leading cross-functional teams, mentoring staff, and driving organizational change., • Excellent strategic thinking and problem-solving skills, with the ability to navigate complex issues and make data-driven decisions., • Exceptional written and verbal communication skills, with the ability to present complex clinical data and trial parameters to both internal and external stakeholders., • Proficient in Microsoft Office Suite; experience with clinical trial management systems (CTMS) and other clinical development tools is a plus. Additional Details This is a remote position open to individuals in the United States, with travel requirements. The role will require travel to clinical study sites and external vendors as needed to manage relationships and to provide technical and project oversight, as well as periodic face-to-face team meetings. The travel time is expected to be roughly 25% of total working hours. The salary range for this position is $270,000 USD to $305,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

Job Description Invivoscribe is an industry pioneer, dedicated to Improving Lives with Precision Diagnostics®. Invivoscribe has been the global leader in driving international standardization of testing and accelerating patient access to the newest and best cancer treatments for over 25 years. Headquartered in sunny San Diego, California with locations across the world, we offer a comprehensive portfolio of products and services. We work with key collaborators to develop molecular assays, reagents, controls and bioinformatics tools under ISO 13485 design control that are used by over 700 clinical laboratories in over 160 countries. Our global network of laboratories offers internationally standardized next generation molecular and flow cytometry panels to support drug development and accelerate drug approvals worldwide. We work with pharmaceutical partners and international regulatory agencies across the globe to develop companion diagnostics, which are necessary to gain approval of new drugs and treatments for cancer patients. Our harmonized ISO15189 accredited and CLIA/CAP clinical laboratories offer a test menu focused on biomarkers which are clinically actionable to support therapeutic decisions, measurable residual disease (MRD) testing, patient stratification, and trial enrollment, all designed to accelerate approvals of new oncology drugs and treatments. For 25 years, we have been at forefront of precision diagnostics, and we’re just getting started! We are looking to add a Senior Accountant, Financial Analysis & Reporting to support the team in maintaining the accuracy and integrity of financial transactions and records with a focus on General Ledger (GL), Accounts Payable (AP), fixed assets, and lease accounting. This position also ensures timely and accurate month-end close, supports financial reporting and compliance, and provides variance and trend analysis to management. As a core user of Oracle Fusion ERP, this role uses the system to extract data, prepare reports, and assist in ensuring the completeness and accuracy of information provided to management and auditors. Core Responsibilities Include: General Accounting & Compliance • Prepare and review journal entries, reconciliations, accruals, and adjustments., • Support monthly, quarterly, and year-end close activities, ensuring accurate and timely reporting., • Maintain fixed asset records and lease schedules, including depreciation and CAM reconciliations., • Ensure compliance with tax and regulatory reporting requirements., • Assist in preparing monthly and quarterly financial reports and management packages., • Perform budget-to-actual variance analysis and explain key drivers., • Assist with annual budget preparation and periodic reforecasting., • Support inventory costing and margin analysis as needed., • Serve as day-to-day owner of Oracle Fusion processes within Accounting., • Monitor accuracy of account structures, posting, and reconciliations., • Ensure GL, AP, Fixed Asset, and Lease modules are maintained in alignment with accounting policies., • Partner with IT and Controller to resolve system issues or implement process changes., • Provide guidance to colleagues on use of Oracle Fusion for accounting tasks and reporting., • Recommend improvements or automation opportunities to enhance efficiency of month-end close and reporting. You Bring: • Bachelor’s degree in Finance, Accounting or related field of study and, typically, 5+ year’s relevant experience. Equivalent combination of academics and experience may be considered., • Strong ERP experience with an understanding of system tables and account mapping dimensions; Oracle cloud highly advantageous., • A beautiful modern facility centrally located in San Diego County, with many jobs conducive to flexible scheduling and telework options., • A welcoming breakroom for gathering with hosted hot/cold beverages and healthy convenience foods, and an available micro-market to get you through the day., • A positive workplace culture with an emphasis on support, respect and belonging., • A diverse and inclusive work environment where you will learn, grow, and make new friends.