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We're searching for all-around amazing Optometric Technicians to work hand in hand with our Optometrists to give each eye exam patient a stellar experience in our stores. You'll help manage a high volume of patients, complete pre-testing, support with new contact lens insertion and removal training, deliver video assisted eye exams (where applicable), collect critical data, and generally keep our eye exam operations running extra smoothly. Sounds like the job for you? Keep reading. What you'll do: ● Act as the primary liaison between doctor and patient, establishing a great rapport with all eye exam patients ● Perform preliminary clinical data collection (including but not limited to: autorefraction, visual acuity, eye pressure, pupil testing, ocular motility testing, retinal imaging, and lensometry) ● Support with in person and video assisted eye exam appointments as available ● Support new contact lens wearers through delivering insertion and removal training. Additionally, train additional team members (as directed by the Store Leader) on how to deliver insertion and removal training ● Support the patient and store team through each step of the booking process with appointment confirmation, annual exam outreach, and contact lens follow up to ensure the patient has a seamless appointment experience ● Efficiently manage the flow of our patients through the eye exam process ● Provide support to the doctor in maintaining meticulous and accurate records of data collected ● Help with the preparation of reports to other medical professionals as needed ● Ensure adherence to governmental regulations and privacy policies (e.g. HIPAA/PIPEDA), and company procedures ● Prepare and maintain an organized exam room by replenishing supplies, keeping contact lens trials up-to-date, ensuring the highest standards of cleanliness for our equipment, and performing ongoing maintenance and calibration as needed ● Support the retail sales team as directed by the Store Leader Who you are: ● Professional, articulate, and have a compassionate approach to patient care ● A team player who's effective and efficient when collaborating and communicating with doctors, the store team, and patients ● Excellent with multitasking, organization, and time management in prioritizing appointments to maintain efficient patient flow ● Able to think outside of the box when needed ● Precise and comfortable with technology, and able to quickly learn and effectively use new medical applications ● Excited to work side by side (or virtually!) with a doctor in a high-volume retail setting Extra Credit: ● 1+ years of experience in a medical environment supporting doctors ● Exceptionally knowledgeable about eyewear and able to accurately describe the features and benefits of different offerings. (Patients have questions, and we always like to have answers.) ● Working knowledge of G Suite ● Previous work experience with optometry, electronic health records, or medical care ● Familiar with healthcare technology systems and equipment (EMR systems, retinal cameras, exam room equipment) ● Completion of an Optometric Technician training program or CPOT certification (Certified Paraoptometric Technician) In compliance with local and state requirements, Warby Parker is committed to pay transparency. We offer a comprehensive compensation package that includes not only a competitive base salary/hourly rate but also variable compensation for eligible employees. For applicable postings, the range listed is a good faith estimate of the compensation for this position at the time of posting. Final compensation is thoughtfully determined by a variety of factors, including the candidate's qualifications, experience, internal equity, and relevant market data. For applicable postings, non-exempt employees are eligible for overtime pay if you are required to work more than 40 hours in a workweek. Some benefits of working at Warby Parker for full-time employees: • Health, vision, and dental insurance, • Life and AD&D Insurance, • Paid sick leave1, • Paid Holidays1, • Vacation days per year1, • Retirement savings plan (401(k)), • Parental leave (non-birthing parents included), • Short-term disability, • Employee Stock Purchase Plan, • Employee Assistance Program (EAP), • Bereavement Support, • Optical Education Reimbursement, • Free eyewear, • Employee Assistance Program (EAP), • Employee Stock Purchase Plan, • Free eyewear, • Paid sick leave2, • And more (just ask!) Warby Parker will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, and the California Fair Chance Act. If you are a California resident, please review the additional privacy disclosures available in Section 8 of our Privacy Policy, which provides a summary of how we collect, use, disclose, and share personal information about you and explain your rights under the California Privacy Rights Act (“CPRA”). It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. CO only: The application window for this position is anticipated to close on the apply before date listed. We encourage interested candidates to apply through our Career website. 1 WA only: Full-Time employees’ paid sick leave is accrued at a rate of 1 hour per every 26 hours worked. Full-time employees receive 5 paid holidays and 5-10 vacation days per year (after waiting period, depending on tenure and hours worked). 2 WA PT only: Paid sick leave (accrued at a rate of 1 hour per every 30 hours worked). • Job Identification1947, • Job CategoryOptometric Technician, • Posting Date03/23/2026, 03:22 PM, • Job SchedulePart time, • Locations 92108(On-site), • Minimum Rate/Salary19.90, • Maximum Rate/Salary19.90

Our FSP team is currently seeking a Sr. CRA 2 with 4+ years of monitoring as well as strong Oncology monitoring experience residing on the West Coast. WHAT YOU WILL DO You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards. Responsibilities: * Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned - * Responsible for all aspects of site management as prescribed in the project plans * General On-Site Monitoring * Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study * Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements * Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document Monitor data for missing or implausible data * Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested * Complete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of SAEs * Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management * Assist with training of new employees, eg. co-monitoring * Coordinate designated clinical projects as a Local Project Coordinator (with supervision, ifapplicable) and may act as a local client contact as assigned * Perform other duties as assigned by management Requirements * University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure) * 4+ years of Clinical Monitoring experience * Oncology experience is required * 60-70% overnight travel The important thing for us is you are comfortable working in an environment that is: * Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue. * Changing priorities constantly asking you to prioritize and adapt on the spot. * Teamwork and people skills are essential for the study to run smoothly. * Technology based. We collect our data directly into an electronic environment. Work Environment: * Work is performed in an office environment with exposure to electrical office equipment. * Frequent travel to clients/ site locations with occasional travel both domestic and international. Physical Requirements: * Ability to sit for extended periods and operate a vehicle safely. * Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. * Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. * Ability to access and use a variety of computer software developed both in-house and off-the-shelf. * Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. * Regular and consistent attendance. * Varied hours may be required. * Target Pay Range: $115 - $140K #LI - Remote Applications will be accepted on an ongoing basis. Learn more about our ___.

Executive Director, Clinical Development (MD) On-site in San Diego Must have an MD Overview The organization is seeking a senior physician leader with extensive experience in obesity and cardiometabolic drug development to establish and lead clinical strategy across its therapeutic pipeline. This role will provide medical and strategic direction for programs spanning early clinical research through late-stage development, with particular focus on obesity and related metabolic disorders. The Executive Director will guide the advancement of novel therapeutics by integrating clinical science, regulatory strategy, and operational execution. The successful candidate will have a proven record of leading complex clinical programs, influencing cross-functional teams, and delivering high-quality clinical data in a biotechnology or pharmaceutical environment. Key Responsibilities Clinical Strategy & Portfolio Leadership • Define and oversee clinical development strategy for obesity and metabolic disease programs across all phases of development., • Provide senior medical leadership for study design, conduct, and interpretation, including endpoints, patient populations, safety oversight, and benefit–risk evaluation., • Serve as the company’s internal medical authority for metabolic disease programs and advise executive leadership, project teams, and external partners., • Provide accountability for execution and quality of assigned clinical programs., • Oversee development of clinical protocols, amendments, and integrated development plans., • Ensure study deliverables are completed within timelines, budget, and quality expectations., • Serve as the senior medical representative in interactions with regulatory agencies for assigned programs., • Partner with Regulatory Affairs, Clinical Operations, Biostatistics, CMC, and Program Management to align development and submission strategies., • Lead medical contributions to key regulatory documents including INDs, investigator brochures, clinical study reports, and regulatory briefing materials., • Participate in regulatory meetings and health authority interactions (e.g., FDA, EMA)., • Lead collaboration across clinical operations, pharmacovigilance, translational sciences, biostatistics, and commercial teams., • Build relationships with key opinion leaders, investigators, and advisors in obesity and metabolic disease., • Medical degree (MD) required, • 10+ years of clinical development experience within the pharmaceutical or biotechnology industry, • Demonstrated experience leading clinical studies in obesity or metabolic disease, • Significant leadership experience, including oversight of teams or programs, • Track record of directing clinical programs across multiple development stages, • Strong understanding of drug development strategy, clinical operations, and planning, • Expertise in clinical data analysis and interpretation, • Familiarity with SOPs, GCP, ICH guidelines, and regulatory compliance, • Experience supporting regulatory submissions and agency interactions (IND, NDA/BLA), • Board certification in Endocrinology, Diabetes, Metabolism, or related specialty, • Experience within a clinical research or biotech operational environment, • Strategic thinking and program prioritization, • Strong cross-functional collaboration and leadership, • Effective decision-making and problem solving, • Organizational and communication skills, • Full-time position, • Competitive compensation based on experience, • Equity participation and performance bonus eligibility, • Retirement plan with employer match, • Medical, dental, and vision coverage, • Flexible spending programs, • Life insurance and employee assistance programs, • Paid time off and holidays

We are seeking a Clinical Research Coordinator I to support the Naval Health Research Center (NHRC), Operational Infectious Diseases (OID) Directorate by coordinating and managing clinical research studies. The OID Directorate conducts ongoing, laboratory-based surveillance of US military populations in unique environments to quantify and study the etiology of infectious illnesses. Test specimens are collected from ongoing surveillance programs and from special investigations of febrile illnesses and pneumonia among military personnel or civilians (recruits, forces afloat, deployed forces, outbreaks of concern, and border populations). In addition to the utilization of portable, rapid assay technologies to identify pathogens in the field, test specimens and limited epidemiologic data, when approved by the Institutional Review Board (IRB), are provided to the NHRC laboratory where diagnostics and, in some instances, in-depth pathogen characterization is conducted. Results are provided to sponsors, the Armed Forces Health Surveillance Center, local investigators and collaborators, and, when applicable, county health units to guide proper responses that ultimately affect both the readiness of US forces and the safety of public health. CAMRIS International, LLC, is a dynamic medical research and development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today's most effective, evidence-based best practices. Our core practice areas include vaccine research, development, and production; microbiology and infectious disease research; biodefense; clinical research; global health security; and HIV/AIDS programs. Our employees enjoy a diverse, collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad. Responsibilities Primary Responsibilities • Patient Recruitment and Consent: Identifies, recruits, and obtains informed consent from potential study participants in compliance with study protocols and ethical guidelines., • Help lead recruitment efforts, developing and refining strategies to meet enrollment targets., • Make independent decisions about how to target and select participants, and whether a potential participant meets eligibility criteria., • Manage and coordinate complex clinical trials: Handle complex logistics of trials, solve problems related to compliance or participant concerns, and make adjustments to protocols based on emerging situations during the study., • Study Protocol Design and Oversight: Interprets study protocols, assessing feasibility, and modifies procedures to align with the objectives of clinical trials., • Study Visits: Coordinates and conducts study visits, including patient interviews, sample collection, and other protocol-driven procedures., • Data Collection and Entry: Accurately collects, records, and manages study data. Ensures timely data entry into the Clinical Trial Management System (CTMS)., • Data Analysis and Reporting: Interprets data to make recommendations on the direction of the research and adjusts study parameters based on preliminary findings., • Query Resolution: Works with the study team to resolve data queries and discrepancies in accordance with Good Clinical Practice (GCP) guidelines., • Assists with Institutional Review Board (IRB) submissions and protocol amendments., • Collaborate with principal investigators and sponsors and provide insights based on field experience., • Recommend changes to improve study feasibility and evaluate the implications of protocol adjustments on ongoing activities., • Maintains accurate study documentation and ensures that study protocols are adhered to throughout the study lifecycle., • Ensure that the research team follows procedures. Troubleshoot and resolve any deviations or challenges that may arise., • Develop and implement quality control procedures, identify areas for improvement, and resolve any issues that could impact the validity or integrity of the study outcomes., • Prepares and submits initial and continuing IRB applications, study amendments, and adverse event reports in compliance with NHRC and sponsor requirements., • Ensures all study-related documents are appropriately filed and accessible for audits., • May be required to provide oversight and guidance to Assistant Clinical Research Coordinators and other support personnel., • Remote and On-Site Study Leadership:, • Conduct research activities in varied environments, such as on naval ships or other remote sites, which may involve travel., • Coordinate logistics, including equipment and resource allocation, and serve as a research team representative on-site., • Make real-time decisions regarding study operations and troubleshoot unexpected scenarios to ensure study fidelity and safety., • Performs other duties as assigned. Responsibilities Required • A BA/BS in biological sciences, public health, or equivalent OR five (5) plus years of clinical research experience., • Familiarity with regulatory requirements for clinical trials, including IRB submissions and reporting processes., • Proficiency in Clinical Trial Management Systems (CTMS) and electronic IRB systems., • Strong organizational, communication, and problem-solving skills., • Ability to work both independently and collaboratively in a research setting., • US Citizenship and the ability to obtain and maintain a T3/Secret Clearance. Preferred • Certification in clinical research (such as CCRC or CCRP)., • Experience with infectious disease studies or military health research. Physical Requirements, Workplace Hazards and Conditions, and PPE and Chemical Requirements The physical requirements, workplace hazards and conditions, and PPE and chemical requirements described here are representative of those that a candidate must meet to perform the essential functions of this job. Reasonable accommodation may be provided to enable individuals with disabilities to perform essential job functions. Physical Demands • Constantly conduct sedentary work that primarily involves sitting/standing., • Occasionally conduct light work that includes moving objects up to 20 pounds., • Occasionally conduct medium work that includes moving objects up to 50 pounds., • Occasionally push or pull less than 25 pounds, push or pull 25 - 45 pounds, or push or pull more than 45 pounds., • Occasionally reach above shoulder level., • Constantly use both hands., • Occasionally stand or walk for more than 25 minutes., • Occasionally bend, reach, or twist repeatedly., • Occasionally kneel, squat, or stoop., • Occasionally crawl or climb., • Occasionally ascend or descend ladders, stairs, scaffolding, ramps, poles, and the like., • Occasionally move self in different positions to accomplish tasks in various environments, including tight and confined spaces., • Occasionally move about to accomplish tasks or move from one worksite to another., • Constantly communicate with others to exchange information., • Occasionally operate motor vehicles or heavy equipment., • Occasional work in low temperatures., • Occasional work in high temperatures., • Occasional work in outdoor elements, such as precipitation and wind., • Occasional work in noisy environments., • Occasional work in small and/or enclosed spaces., • Occasionally wear PPE, including but not limited to gloves, face shields/goggles, safety glasses, and safety shoes., • Occasionally wear a lab coat., • Occasionally wear a disposable dust/surgical mask., • Occasionally wear respirators, such as a disposable respirator mask (N-95), half-face/full-face style, PAPR, SCUBA. Please submit your resume online at . CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.

CAMRIS seeks a Clinical Research Coordinator II to support the Naval Health Research Center (NHRC), Operational Infectious Diseases (OID) Directorate by overseeing and administering research studies and ensuring compliance with study protocols and regulatory requirements. The role involves assisting with planning, recruiting, and coordinating research subjects, as well as serving as a primary liaison for projects, along with the principal investigator (PI). The Clinical Research Coordinator II oversees staff services, maintains record-keeping systems, and ensures seamless study operations. This position provides an exciting opportunity to lead critical research initiatives in infectious diseases, supporting military health and global public health efforts. The Clinical Research Coordinator II will help ensure the success of clinical trials and research projects at NHRC. The OID Directorate conducts ongoing, laboratory-based surveillance of US military populations in unique environments to quantify and study the etiology of infectious illnesses. Test specimens are collected from ongoing surveillance programs and from special investigations of febrile illnesses and pneumonia among military personnel or civilians (recruits, forces afloat, deployed forces, outbreaks of concern, and border populations). In addition to the utilization of portable, rapid assay technologies to identify pathogens in the field, test specimens and limited epidemiologic data, when approved by the Institutional Review Board (IRB), are provided to the NHRC laboratory where diagnostics and, in some instances, in-depth pathogen characterization is conducted. Results are provided to sponsors, local investigators and collaborators, and, when applicable, county health units to guide proper responses that ultimately affect both the readiness of US forces and the safety of public health. • Study Administration and Oversight:, • Lead research studies and associated activities to ensure adherence to study protocols, timelines, and regulatory standards., • Monitor, record, and report study progress in close coordination with the PI and study team and assist in study planning to meet milestones and objectives., • Ensure pre-established work scope and study protocols are followed throughout the study lifecycle., • Regulatory Compliance:, • Ensure all activities comply with Institutional Review Board (IRB) requirements and other regulatory standards., • Prepare, obtain, and track agreements and approvals., • Prepare and submit IRB applications, amendments, and continuing reviews., • Maintain accurate study documentation and ensure that study protocols are adhered to throughout the study lifecycle., • Prepare for and participate in monitoring visits, audits, and inspections by regulatory agencies., • Participant Recruitment and Coordination:, • May recruit, screen, and coordinate research subjects as per study protocols., • May obtain informed consent and schedule subject visits., • Ensure compliance with study requirements., • Frequent and clear communication with sites to ensure all aspects of the study are communicated and the sites remain engaged., • Liaison and Communication:, • Serve as the primary administrative point of contact between investigators, research staff, and external stakeholders., • Facilitate communication between clinical teams, sponsors, and regulatory authorities to ensure smooth study execution., • Administration and Staff Services:, • Serve as an administrative point of contact between investigators, research staff, and external stakeholders., • Facilitate communication between study teams, sponsors, and regulatory authorities to ensure smooth study execution., • Sample Collection, Data Management, and Reporting:, • Monitor studies to ensure samples are collected per study requirements., • Supervise data collection and entry to ensure accuracy and completeness., • Address data queries and resolve discrepancies in accordance with Good Clinical Practice (GCP) guidelines., • Prepare regular progress reports and assist with study-related presentations., • US Citizenship and the ability to obtain and maintain a T3/Secret Clearance., • A BA/BS in sciences, public health, epidemiology or equivalent PLUS one to two years of clinical research and management experience OR 8+ years of research experience, including two years of research management experience., • Familiarity with surveillance-based research, IRB submissions and reporting processes., • Strong understanding of research principles, study design, and regulatory requirements., • Familiarity with/electronic IRB (eIRB) systems., • Proactive problem-solving skills, organizational, communication, and leadership skills., • Ability to work both independently and collaboratively in a research setting., • Ability to manage multiple projects and prioritize tasks in a dynamic research environment., • Ability to work in a fast-paced environment and able to balance completing priorities and deadlines., • Ability to present studies to collaborators and staff.Preferred, • Familiarity with Tableau and Power BI experience is desired., • Experience with infectious disease studies or military health research., • Proven experience in supervisory roles within clinical and surveillance studies. Physical Requirements, Workplace Hazards and Conditions, and PPE and Chemical Requirements The physical requirements, workplace hazards and conditions, and PPE and chemical requirements described here are representative of those that a candidate must meet to perform the essential functions of this job. Reasonable accommodation may be provided to enable individuals with disabilities to perform essential job functions. Physical Demands • Constantly conduct sedentary work that primarily involves sitting/standing., • Occasionally conduct light work that includes moving objects up to 20 pounds., • Occasionally conduct medium work that includes moving objects up to 50 pounds., • Occasionally push or pull less than 25 pounds., • Occasionally reach above shoulder level., • Constantly use both hands., • Occasionally stand or walk for more than 25 minutes., • Occasionally bend, reach, or twist repeatedly., • Occasionally kneel, squat, or stoop., • Occasionally crawl or climb., • Occasionally have clear vision (near and/or far), depth perception, peripheral vision, and/or visual acuity.Physical Activities, • Occasionally ascend or descend ladders, stairs, scaffolding, ramps, poles, and the like., • Occasionally move self in different positions to accomplish tasks in various environments, including tight and confined spaces., • Occasionally move about to accomplish tasks or move from one worksite to another., • Constantly communicate with others to exchange information., • Constantly assess the accuracy, neatness, and thoroughness of the work assigned.Environmental Conditions, • Occasional work in low temperatures., • Occasional work in high temperatures., • Occasional work in outdoor elements, such as precipitation and wind., • Occasional work in noisy environments., • Occasional work in small and/or enclosed spaces., • Occasional work in environments where no adverse environmental conditions are expected.PPE and Chemical Requirements, • Occasionally wear PPE, including but not limited to gloves, face shields/goggles, safety glasses, and safety shoes., • Occasionally wear a lab coat., • Occasionally wear a disposable dust/surgical mask. CAMRIS offers a comprehensive benefits package, including medical, dental, and vision insurance for individuals and families, FSAs, HSA, life and AD&D insurance, short- and long-term disability, legal services, voluntary hospital indemnity, critical illness and accident insurances, EAP, pet insurance, 401(k) with employer match and Roth option, tuition and professional reimbursement, public transportation support in the DMV area, a referral bonus program, vacation with tenure-based increases, PTO, 11 paid holidays, paid bonding leave, and paid supplemental short-term disability. Employment is contingent upon successful completion of a secret-level background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment, education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding.

Clinical Operations Manager Kelly Science and Clinical is hiring for one of our growing Site Network Clients to work as a direct employee onsite in San Diego CA. • Opportunity: Direct hire, • Location: San Diego CA – On-site, • Travel: 5-10% as needed, • Salary: 95,000.00 – 105,000.00 annually, • In addition to benefits such as Medical, Dental, Vision, 401k, PTO and more About the Company: We are people with a purpose, dedicated to advancing medical innovation and healing technology through groundbreaking research, diligent patient care and strong executive management. Our hands-on management team and medical staff are committed to rapid, efficient trials that bring life-changing drugs to market faster; our research staff brings years and years of “in the trenches” experience conducting Phase 1-4 clinical studies. And each one is dedicated to curing disease and improving individual quality of life. Mission Statement: Our mission is to advance medical research by enrolling diverse populations in high-quality clinical trials. We are committed to maintaining the highest standards of integrity and excellence, and to ensuring that every participant receives respectful and compassionate care. We strive to build a tightly knit, supportive and collaborative environment where our team members can thrive and make meaningful contributions to human health. About the Role: The Clinical Operations Manager will oversee the day-to-day functions of the clinic, manage the office personnel, as well as manage daily operational and administrative activities. This individual will act as a liaison between patients, medical staff, clinic staff, and management to ensure optimal clinic functioning. Additionally, the Manager will play an essential role in ensuring policies and procedures, ensure that the clinic delivers exceptional patient care, and function efficiently. ESSENTIAL DUTIES AND RESPONSIBILITIESinclude the following. Other duties may be assigned. • Comply with all company policies, procedures and conduct., • Strictly adhere to confidentiality and compliance standards., • Manage and train clinic site personnel., • Identify and implement strategies to expand the research capabilities at the site - in line with the overall site business plan., • Oversee the implementation and maintenance of ACN quality standards at the site ensuring that the conduct of clinical studies and the collection of patient data is in accordance with ICH GCPs., • Work with the Medical Director/PI to address any study and/or clinical quality related matters., • Ensure timely and appropriate communications occur with Sponsors and IRBs as necessary., • Develop site staffing plans to ensure the successful and efficient conduct of research studies. Identify and fulfil any site resource needs which are necessary to successfully conduct and/or recruit research studies., • Oversee the development of the patient recruitment plan and patient outreach process. Make ongoing adjustments/modifications to recruitment strategies based upon the timely review of results to ensure financial and study-specific targets. Closely collaborate with any external vendors to facilitate successful patient enrollment strategies., • Read, comprehend and communicate study protocols., • Oversee SIV, PSDV and IMV., • Manage and facilitate study startup documentation, training, supplies and timelines of study protocols., • Work closely with CRO/CRA/IRB., • Maintain site regulatory files., • Document temperatures for IP stored on-site., • Audit study e-source documentation to comply with study protocols., • Other tasks as assigned. QUALIFICATION REQUIREMENTS: The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. EDUCATION and EXPERIENCE: • Bachelor’s degree preferred in healthcare or equivalent clinical research experience., • 5+ years of clinical management experience or equivalent applicable experience in clinical research industry, • 3 years' experience working as a Clinical Research Coordinator, required., • Comprehensive knowledge of FDA, GCP & confidentiality., • Proven success in managing teams and working in direct patient care, required., • Proficient problem-solving skills & conflict resolution., • Proficient in Microsoft Word, Excel and PDF., • Excellent verbal and written communication skills., • A proven ability to constantly prioritize multiple projects in a rapidly changing environment., • Must be comfortable with a rapid-growth company.

Moores Cancer Center 3855 Health Sciences Drive, San Diego, CA 92037, United States Filing Deadline: Fri 4/10/2026 ___ UC San Diego values and welcomes people from all backgrounds. If you are interested in being part of our team, possess the needed licensure and certifications, and feel that you have most of the qualifications and/or transferable skills for a job opening, we strongly encourage you to apply. UCSD Layoff from Career Appointment: Apply by 3/31/2026 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor. Reassignment Applicants: Eligible Reassignment clients should contact their Disability Counselor for assistance. Established in 1978, Moores Cancer Center is the region's only National Cancer Institute-designated Comprehensive Cancer Center. This designation is reserved for centers with the highest achievements in cancer research, clinical care, education and community contributions. Under the direction of the Medical Director of the Moores Cancer Center Infusion Center, the Sr. Physician Assistant (PA) will function as a provider of patient care for patients receiving treatment in the Infusion Center. The PA will provide patient care oversight, including management of toxicities and/or reactions to IV treatments. Direct supervision will occur by assigned medical oncologists. The position requires a strong emphasis on the management of patients undergoing cancer and non-cancer related treatments, including clinical trials, BMT, chemotherapy, biologic and immunotherapies. This position will provide patient care coverage for our various Moores Cancer Center infusion locations. While not required, a cover letter is highly recommended when applying to this position. * Must be a graduate from a physician assistant program approved by the Accreditation Review Commission on Education for the Physician Assistant (ARC-PA). * California Physician Assistant (PA) license. * Current PA Certification from NCCPA. * Current ART certification, or BLS/CPR and ACLS certifications at time of hire with commitment to get ART within six (6) months of hire date. * One (1) or more years of recent work experience as a licensed Physician Assistant in heme/onc, infusion, and/or internal medicine with a strong focus on patients with hematologic or oncologic conditions. * Theoretical background in: anatomy, physiology, general medicine, pulmonary, emergency and critical care medicine, management of common diseases, concepts of medicine and surgery, therapeutics including pharmacology, counseling techniques and interpersonal dynamics. * Proven ability to perform initial history, and physical examination, identify major medical problems, and formulate appropriate plans of action. * Demonstrated knowledge of common diagnostic tests, exams, and procedures used in a clinic setting. * Must understand purpose, required supplies and/or equipment, how to perform procedure accurately, infection control, and accurate documentation of medical chart. * Demonstrates advanced clinical judgment and critical thinking skills to assess and manage patients in an oncologic outpatient setting. * Demonstrates ability to independently manage patients in a fast-paced setting, using evidence-based clinical judgment and appropriate escalation of care. * Experience coordinating multidisciplinary care. * Strong verbal and written communication and documentation skills, with the ability to guide care teams and educate patients and families. Consistently demonstrates professionalism, empathy, and kindness to staff and patients. • Two (2) or more years of Oncology Infusion or Hematology Oncology experience as a Physician Assistant., • Must be able to work various hours and locations based on business needs., • Must be able to obtain UCSD Medical Staff privileges and maintain during employment. Due to advanced practice credentialing eligibility, clinical advanced practice experience must be within the last two years. Annual Full Pay Range: $162,530 - $214,104 (will be prorated if the appointment percentage is less than 100%) Hourly Equivalent: $77.84 - $102.54 Factors in determining the appropriate compensation for a role include experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. The Hiring Pay Scale referenced in the job posting is the budgeted salary or hourly range that the University reasonably expects to pay for this position. The Annual Full Pay Range may be broader than what the University anticipates to pay for this position, based on internal equity, budget, and collective bargaining agreements (when applicable). If employed by the University of California, you will be required to comply with our Policy on Vaccination Programs, which may be amended or revised from time to time. Federal, state, or local public health directives may impose additional requirements. If applicable, life-support certifications (BLS, NRP, ACLS, etc.) must include hands-on practice and in-person skills assessment; online-only certification is not acceptable. UC San Diego Health is the only academic health system in the San Diego region, providing leading-edge care in patient care, biomedical research, education, and community service. Our facilities include two university hospitals, a National Cancer Institute-designated Comprehensive Cancer Center, Shiley Eye Institute, Sulpizio Cardiovascular Center, the only Burn Center in the county, and dozens of outpatient clinics. We invite you to join our team! Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached. To foster the best possible working and learning environment, UC San Diego strives to cultivate a rich and diverse environment, inclusive and supportive of all students, faculty, staff and visitors. For more information, please visit ___. The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law. For the University of California's Anti-Discrimination Policy, please visit: ___ UC San Diego is a smoke and tobacco free environment. Please visit ___ for more information. UC San Diego Health maintains a marijuana and drug free environment. Employees may be subject to drug screening. Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts an offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; or have filed an appeal of a finding of substantiated misconduct with a previous employer. a. "Misconduct" means any violation of the policies governing employee conduct at the applicant's previous place of employment, including, but not limited to, violations of policies prohibiting sexual harassment, sexual assault, or other forms of harassment, or discrimination, as defined by the employer. For reference, below are UC's policies addressing some forms of misconduct:

Job Description Title: Sr. Packaging Specialist Location: San Diego, CA 92121 Duration: 03 Months Onsite Position - Shift - Mon-Fri 8AM - 4:30PM Description: The Sr. Packaging Specialist must be able to work in a team environment to offer quality packaging and labeling of customer’s clinical trials. This position is expected to lead production rooms and ensure quality product is outputted from production batch records. Additionally, this role will have responsibilities for label control and training of new staff. Employees will be involved with handling look-alike products and labeling. Clinical operations can be run as a blister fill, bottle fill, pouch, carding, vial/syringe inspection or hand assembly. Employees will also be involved with de-inking of product and capsule manufacturing. These individuals must be detail oriented in order to work with multiple look-alike products at the same time. Essential Functions: • Lead production rooms and runs from pre-line, execution, to post-line activities, • Perform production EBR review, • Responsibilities for label control including label printing, creation of master blinding forms, and initial/final inspection of labels, • Fastchain Productions and Management of 3-day Turnaround Time, • JDE SME for production activities, • Responsible and perform OJT for production team members, • Shared responsibilities with the Production Manager on maintaining the production schedule and management of staff in rooms on a day-to-day basis, • May be responsible for assisting investigations related to any deviations or customer complaints from the result of operational processes, • Inspect blister cavities for missing products, burnt product, holes in foil, print registration, missing print, crushed blisters and seal integrity., • Fill tablet, bottle, desiccant and closure hoppers. Hand count product using counting trays., • Manufacturing responsibilities include de-inking product, tablet breaking, product placement into oversized capsules and capsule inspection., • Inspect bottles for misalign closures, print registration and missing print copy., • Inspect seal integrity of pouch, print registration and missing print copy., • Inspect blister units and place them into properly assigned card locations for multi-fill operations., • Responsible for cleaning machine equipment and production rooms as stated in cleaning SOP’s., • Fill in all appropriate information in the cleaning logbooks., • Responsible for cleaning product contact parts., • When working on look-alike products you are only allowed to work with your assigned product. Multi-fill projects require that employees do not touch or help other employees that are assigned different products., • Responsible for cleaning production rooms with three bucket sponge mop cleaning system which includes ceilings, walls and floors., • All clinical labels must be inspected and require 100% accountability. Clinical labels can be either manually or automatically applied., • Sealed clinical cards must be inspected for missing copy, poor seal, smudges and dirt, misalign blister units and burnt product., • Inspection required for vials, ampoules and syringes utilizing black and white light boxes., • Cold storage packaging will also be required working with cold products, both outside and inside refrigeration conditions., • Assembly work required, which may include utilizing barcode scanning equipment and computers., • Other duties as assigned. Position Requirements: Education or Experience: • Bachelor’s degree preferred., • Minimum of 6 years of relevant industry experience in a cGMP environment, or comparable pharmaceutical or clinical knowledge and experience., • Minimum of 4 years of operating and maintaining packaging equipment (blistering, bottling, carding) or relevant packaging equipment experience.

East Campus Office Building (ECOB) 9444 Medical Center Drive, San Diego, CA 92037, United States Extended Review Date: Tue 3/17/2026 ___ UC San Diego values and welcomes people from all backgrounds. If you are interested in being part of our team, possess the needed licensure and certifications, and feel that you have most of the qualifications and/or transferable skills for a job opening, we strongly encourage you to apply. UCSD Layoff from Career Appointment: Apply by 11/05/2025 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor. Special Selection Applicants: Apply by 11/17/2025. Eligible Special Selection clients should contact their Disability Counselor for assistance. This position will work a hybrid schedule which includes a combination of working both onsite at La Jolla and remote. UC San Diego Department of Dermatology is a dynamic and growing academic department founded in 2015 within the School of Medicine bringing together a team of 70+ core and voluntary faculty specializing in Adult and Pediatric & Adolescent Dermatology. Dermatology faculty and staff are committed to achieving excellence in clinical care, research and education. Our shared goals are to provide our patients with exceptional clinical care, to advance diagnostic and treatment options for skin diseases through innovative research and to cultivate the next generation of physicians and scientists to be future leaders in Dermatology. The Assistant Department Business Officer (ADBO) is a senior administrative leader responsible for ensuring the effective financial, research, operational, and personnel management of the Department of Dermatology. This role reports directly to the Department Administrative Vice Chair and works in close collaboration with the Department Chair to support and advance the department's academic, clinical, research, and educational missions.Responsibilities also include supervising the administrative services of a large academic department within a school OR college OR non-academic department (program). Typically reports to a manager. Administrative services include all or some of the following functions: IT, facilities, student services, contracts and grants, budgetary financial management and / or human resources. Supervises support and / or professional staff. The ADBO provides strategic and operational leadership across key areas. * Nine years of related experience, education/training, OR an Bachelor's degree in related area plus five years of related experience/training. * Solid knowledge of the organization's processes, protocols and procedures with a focus on budget, account and fund management and / or personnel management within labor contract(s) and personnel policy. * Solid knowledge of common organization-specific and other computer application programs. * Solid interpersonal skills including verbal and written communication, active listening, critical thinking, persuasiveness, advising, and counseling to effectively motivate others. * Solid skills to quickly evaluate complex issues and identify resolutions. * Solid organizational and customer service skills to effectively manage multiple priorities. * Solid knowledge of financial analysis and reporting techniques; human resources and risk management planning; accounting and payroll. * Demonstrated skills in employee supervision and HR administration. * In depth knowledge of federal, state, and private agency contract and grant regulations and requirements from proposal preparation through close out; including but not limited to cost accounting standards. Ability to independently interpret and implement appropriate UCSD and agency policies, procedures, and guidelines. * Advanced knowledge and application of principles and practices of financial management, fiscal planning and analysis. * Advanced experience projecting salary, benefit and indirect costs with knowledge of payroll and personnel regulations including impact of salaries, merits, range adjustments and benefit costs. * Proven ability to provide comprehensive financial management of extramural funds with multiple indexes, institutions, PI's, and sites. Ability to analyze complex financial issues, recognize potential impact, identify creative and alternative solutions and make recommendations. * Demonstrated computer proficiency. Skill in the use of various software, such as databases, spreadsheets and word- processing. Ability to use available computer tools , i.e. Microsoft Office, to streamline work. Proven ability to assess and contribute to development of automated systems to facilitate pre and post award administration. * Familiarity with Division faculty, staff, student, and laboratory contacts involved in the purchasing process with ability to advise on initiation and control of expenditures. * Demonstrated organizational skills. Ability to work independently, organize time and set priorities to meet established deadlines and to shift priorities and workload to frequently accommodate new and more urgent tasks. * Demonstrated skill in setting up and maintaining accurate filing systems. * Occasional evenings and weekends may be required. * Must be willing and able to travel Campus, VA, Children's Hospital, and various UCSD sites. * Employment is subject to a criminal background check. Pay Transparency Act Annual Full Pay Range: $88,000 - $161,600 (will be prorated if the appointment percentage is less than 100%) Hourly Equivalent: $42.15 - $77.39 Factors in determining the appropriate compensation for a role include experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. The Hiring Pay Scale referenced in the job posting is the budgeted salary or hourly range that the University reasonably expects to pay for this position. The Annual Full Pay Range may be broader than what the University anticipates to pay for this position, based on internal equity, budget, and collective bargaining agreements (when applicable). If employed by the University of California, you will be required to comply with our Policy on Vaccination Programs, which may be amended or revised from time to time. Federal, state, or local public health directives may impose additional requirements. If applicable, life-support certifications (BLS, NRP, ACLS, etc.) must include hands-on practice and in-person skills assessment; online-only certification is not acceptable. UC San Diego Health Sciences is comprised of our School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, The Herbert Wertheim School of Public Health and Human Longevity Science, and our Student Health and Well-Being Department. We have long been at the forefront of translational - or "bench-to-bedside" - research, transforming patient care through discovery and innovation leading to new drugs and technologies. Translational research is carried out every day in the hundreds of clinical trials of promising new therapies offered through UC San Diego Health, and in the drive of our researchers and clinician-scientists who are committed to having a significant impact on patient care. We invite you to join our team! Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached. To foster the best possible working and learning environment, UC San Diego strives to cultivate a rich and diverse environment, inclusive and supportive of all students, faculty, staff and visitors. For more information, please visit ___. The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law. For the University of California's Anti-Discrimination Policy, please visit: ___ UC San Diego is a smoke and tobacco free environment. Please visit ___ for more information. UC San Diego Health maintains a marijuana and drug free environment. Employees may be subject to drug screening. Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts an offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; or have filed an appeal of a finding of substantiated misconduct with a previous employer. a. "Misconduct" means any violation of the policies governing employee conduct at the applicant's previous place of employment, including, but not limited to, violations of policies prohibiting sexual harassment, sexual assault, or other forms of harassment, or discrimination, as defined by the employer. For reference, below are UC's policies addressing some forms of misconduct:

Other San Diego, CA 92093, United States Initial Review Date: Fri 3/20/2026 ___ UC San Diego values and welcomes people from all backgrounds. If you are interested in being part of our team, possess the needed licensure and certifications, and feel that you have most of the qualifications and/or transferable skills for a job opening, we strongly encourage you to apply. This position is a part-time limited position with the possibility of extension/career conversion. Reassignment Applicants: Eligible Reassignment clients should contact their Disability Counselor for assistance. The qualifications of this position have been slightly modified as of 3/10/2026. UC San Diego Health is a Magnet designated organization, which is a prestigious recognition that applies to only 10% of all U.S. hospitals. Magnet is the "gold standard" for nursing excellence and is based on strengths in five key areas, which include transformational leadership, structural empowerment, exemplary professional practice, new knowledge, innovation and improvements and empirical outcomes. UC San Diego Health has held its Magnet status since 2011. Department of Pediatrics is one of the largest departments within the UCSD School of Medicine with comprehensive clinical programs, extensive basic science and clinical research, and diverse educational opportunities for students, residents and fellows. The internationally renowned faculty play a major role in medical and graduate student training, providing educational and programmatic offerings that span several disciplines and provide diversity to meet the interests of a broad spectrum of students and scholars. More than one hundred trainees at the graduate student and postdoctoral level, as well as more than 300 professional, research and administrative staff who along with the department administrators interact closely with the faculty. The diverse mix of ages, backgrounds, and talents creates a robust work environment with challenging career opportunities and a commitment to continued growth potential. We constantly seek to recruit highly motivated, technologically advanced and interested individuals to become a part of our dynamic cutting-edge research, clinical, and educational environment. Under supervision, the Licensed Vocational Nurse (LVN) provides screening, counseling and vaccine administration at the South Bay Public Health Center in compliance with County policies and procedures. The LVN also provides oversight of clinic procedures including but not limited to maintaining appropriate supply of vaccine, work direction of staff for required tasks, and overall patient flow and clinic operations. The LVN assists with data entry, vaccine inventory and accountability, and/or maintenance of clinic immunization records in the local immunization registry. The LVN assists in the education/training of pediatric and family practice residents and County nursing staff on pediatric vaccine administration and immunization practice management. This position also will be responsible for home visits with participants in immunization-related research studies. Responsibilities vary by study and may include medical record review, immunization history review, telephone and in person communication, scheduling study visits, questionnaires administration, completion of case report forms, vaccine administration, nasal or nasopharyngeal swabs, blood, collection, and other specimen collection while following subjects in longitudinal study protocols for routine and illness visits. The LVN will interact with research team, the UCSD Human Subjects Protection Program, study sponsors, and other research related entities as needed. Performs other duties as assigned. * License issued by the State of California Board of Vocational Nurse Examiners. * Proficiency and certificate for phlebotomy, with experience in pediatrics. * BART or BLS at time of hire with commitment to get BART within 6 months of hire date. * Experience working independently and prioritizing tasks to meet strict guidelines and deadlines. * Proficient at word processing, spreadsheet, and E-mail with experience producing reports, profiles, correspondence, graphs, and spreadsheets to generate and track required data. * Experience performing effectively under conditions of high workload and frequent interruptions. * Experience maintaining patient confidentiality and communicating (verbally and written) with patients, staff and physicians with professionalism, sensitivity and discretion. * Experience and ability to accurately collect, record, transcribe and synthesize clinical data. * Demonstrated experience interacting positively, constructively, and effectively with staff, physicians, patients and the general public. * Excellent organizational skills with the ability to effectively and efficiently coordinate clinical and data activities for the retention of patients in clinical trials. * Ability to administer vaccines via all routes. * Demonstrated experience with clinical research activities and guidelines related to ethical conduct and protection of human subjects. * Experience with the San Diego Regional Immunization Registry software. * Bilingual in English/Spanish. * Ability to interact with the lay and professional public in both Spanish and English. * Employment is subject to a criminal background check and pre-employment physical. * Location: South Bay Public Health Center and will perform home visits throughout San Diego County. * Work Schedule: Must be willing to work a flexible schedule mainly on weekdays but with occasional early mornings, evenings or weekends. * Must have access to reliable transportation and willing to perform home visits. Pay Transparency Act Annual Full Pay Range: $67,756 - $84,209 (will be prorated if the appointment percentage is less than 100%) Hourly Equivalent: $32.45 - $40.33 Factors in determining the appropriate compensation for a role include experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. The Hiring Pay Scale referenced in the job posting is the budgeted salary or hourly range that the University reasonably expects to pay for this position. The Annual Full Pay Range may be broader than what the University anticipates to pay for this position, based on internal equity, budget, and collective bargaining agreements (when applicable). If employed by the University of California, you will be required to comply with our Policy on Vaccination Programs, which may be amended or revised from time to time. Federal, state, or local public health directives may impose additional requirements. If applicable, life-support certifications (BLS, NRP, ACLS, etc.) must include hands-on practice and in-person skills assessment; online-only certification is not acceptable. UC San Diego Health Sciences is comprised of our School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, The Herbert Wertheim School of Public Health and Human Longevity Science, and our Student Health and Well-Being Department. We have long been at the forefront of translational - or "bench-to-bedside" - research, transforming patient care through discovery and innovation leading to new drugs and technologies. Translational research is carried out every day in the hundreds of clinical trials of promising new therapies offered through UC San Diego Health, and in the drive of our researchers and clinician-scientists who are committed to having a significant impact on patient care. We invite you to join our team! Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached. To foster the best possible working and learning environment, UC San Diego strives to cultivate a rich and diverse environment, inclusive and supportive of all students, faculty, staff and visitors. For more information, please visit ___. The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law. For the University of California's Anti-Discrimination Policy, please visit: ___ UC San Diego is a smoke and tobacco free environment. Please visit ___ for more information. UC San Diego Health maintains a marijuana and drug free environment. Employees may be subject to drug screening. Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts an offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; or have filed an appeal of a finding of substantiated misconduct with a previous employer. a. "Misconduct" means any violation of the policies governing employee conduct at the applicant's previous place of employment, including, but not limited to, violations of policies prohibiting sexual harassment, sexual assault, or other forms of harassment, or discrimination, as defined by the employer. For reference, below are UC's policies addressing some forms of misconduct:

UCSD Layoff from Career Appointment: Apply by 03/30/2026 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor. Reassignment Applicants: Eligible Reassignment clients should contact their Disability Counselor for assistance. In 2022, businessman and philanthropist T. Denny Sanford committed $150 million to the creation of the Sanford Stem Cell Institute at UC San Diego. This gift combines current infrastructure with new Centers intended to leverage the advantages of space-based science, including expansion and, in some ways, quite literally launch stem cell research and regenerative medicine at UC San Diego into new spaces, endeavors, and training of future stem cell scientists. Sanford Stem Cell Institute provides essential physical and human resources needed to leverage stem cell research currently being conducted at UC San Diego. Due to the complexity of regenerative medicine projects and substantial institutional investment, daily Sanford Stem Cell Institute personnel work with all 9 Vice Chancellor areas: Academic Affairs; Research Affairs; Equality, Diversity, and Inclusion; Student Affairs; Marine Sciences; Health Sciences; Health System; Chief Financial Officer; Advancement; Resource Management and Planning. As part of UC San Diego, Sanford Stem Cell Institute motivates University-wide change, sustainability, and partnership, focusing on creating the structure under which various innovative regenerative medicine units and initiatives are developed. The new UC San Diego Sanford Stem Cell Institute builds upon a $100 million gift in 2013 from T. Denny Sanford that established UC San Diego as a leader in developing and delivering the therapeutic promise of human stem cells - special cells with the ability to develop into many different cell types and which, when modified and repurposed, have the potential to treat, remedy or cure a vast array of conditions and diseases. The new UC San Diego Sanford Stem Cell Institute includes six (6) stem cell Centers led by Center Directors and Deputy Directors and one (1) Brain Tumor and Neuro-Restoration Program. * Sanford Integrated Space Stem Cell Orbital Research (ISSCOR) Center, for stem cell research that will be conducted in a laboratory bay located aboard the International Space Station currently in low-Earth orbit. * Sanford Stem Cell Fitness and Space Medicine Center, which conducts in-depth space fitness and orbital medicine that can benefit both astronauts and people living on Earth. * Sanford Stem Cell Innovation Center, which will support regenerative medicine company development, including contract research in low-Earth orbit. * Sanford Stem Cell Discovery Center, which conducts basic and translational stem cell research. * Sanford Advanced Therapy Center, which provides fundamental tools and services to move basic research findings to next stages, such as early phase trials. * Sanford Stem Cell Clinical Center, which conducts research to accelerate relevant drug and therapy development in regenerative medicine, including clinical trials. The Strategy and Integration Officer (SIO) is a recognized leader responsible for shaping the strategic direction, integration, and operations of the UC San Diego Sanford Stem Cell Institute (SSCI). Under the direction of the Executive Director of SSCI, the SIO operates in a highly visible and politically sensitive environment, requiring advanced professional judgment to drive critical initiatives. Incumbent leads the growth of key programs, aligning them with institutional priorities while addressing complex policy and operational challenges that impact both on-campus and external venues. With significant influence over program initiatives and development, the SIO provides high-level support and advises executive leadership in planning, risk mitigation, and other issues associated with complex projects of a highly sensitive nature. Integrates and connects with center leaders to ensure there are synergies and cross-collaborations between internal and external programs and partnerships. Provides recommendations based on knowledge of broader data trends in political policies related to stem cell research. Serves as liaison with external parties, providing additional vision and leadership to the Institute. Develops long and short-term plans for the SSCI and implements strategies to achieve its mission. May represent SSCI leadership at national and international meetings, conferences, and committees. Leads the growth of SSCI's research mission through activities intended to foster agency relationships and partnerships for the purpose of research development and pursuing existing federal research opportunities. This position models strong professional ethics, exercising tact and diplomacy when handling sensitive and complex matters in a fluid environment. The incumbent strategizes ways to effectively manage and communicate the SSCI Director's priorities in support of the Institute's mission and service in stem cell research. Uses advanced operational concepts and objectives to resolve highly complex issues. Regularly works on issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Primarily deals with programs and proposals with broad impact across the function, research initiative, program and / or organization. Develops and oversees the implementation of new programs and processes. * Nine years of related experience, education/training, OR an Bachelor's degree in related area plus five years of related experience/training. * Strong communication and interpersonal skills to communicate effectively with all levels of staff and influence, both verbally and in writing. * Experience with developing and executing a strategic plan. * Experience working with governments and/or elected officials. * Ability to use discretion and maintain all confidentiality. * Advanced knowledge of common organizational- or research-specific and other computer application programs. * Advanced project management skills. * Thorough knowledge of organizational or initiative processes, protocols and procedures. * Ability to multi-task with demanding timeframes. * Advanced knowledge of applicable policy analysis techniques. * Advanced analytical / problem-solving skills. * Demonstrated experience coordinating proposals and developing communication to seek non-traditional funding resources. * Seven (7) or more years of related experience * Familiarity with the research interests of SSCI. * Some travel to national and international meetings and conferences. * Must be based in San Diego for in-office presence. Pay Transparency Act Annual Full Pay Range: Unclassified - No data available (will be prorated if the appointment percentage is less than 100%) Hourly Equivalent: Unclassified - No data available Factors in determining the appropriate compensation for a role include experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. The Hiring Pay Scale referenced in the job posting is the budgeted salary or hourly range that the University reasonably expects to pay for this position. The Annual Full Pay Range may be broader than what the University anticipates to pay for this position, based on internal equity, budget, and collective bargaining agreements (when applicable).

About Lantheus Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and United Kingdom, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. Today, we're expanding our portfolio and pipeline across oncology, neurology and cardiology. Through recent acquisitions, along with strategic partnerships across the life sciences ecosystem, we are accelerating our efforts to advance precision medicine and improve patient outcomes around the world. At Lantheus we are purpose-driven, and every employee plays a vital role in our success. We're dedicated to cultivating a high-growth, forward-thinking culture where innovation thrives and diverse perspectives drive meaningful progress. Join us and be part of a company where your contributions make a real impact, because we know someone's health is in our hands. Job Summary The Sr. MSL is a key member of Global Medical Affairs, communicating scientic, clinical and technical information within the medical community, developing and maintaining strong collaborative relationships with Key Opinion Leaders and serving as a therapeutic and radiopharmaceutical expert with internal audiences. Preferred candidates will reside near an international airport. The Sr. MSL demonstrates expertise and extensive knowledge in the eld of oncology, radiopharmaceuticals, medical imaging trends, clinical trials and scientic activities within the oncology therapeutic and medical imaging arena. Continuously updates this expertise and knowledge based on training direction and approved resources provided. This is a remote position open to applicants authorized to work for any employer within the United States. Responsibilities and essential functions: • Identies, develops and maintains long term collaborative relationships with Key Opinion Leaders in assigned territory, • Demonstrates strong communication skills with the ability to present approved scientic data of varying levels of complexity to internal and external customers in both group and one-to-one settings, appropriately adjusted to the audience and in accordance with Company Policies, and applicable laws, regulations and ethical standards, • Demonstrates appropriate response and documents the provision of accurate, approved scientic data in response to unsolicited scientic questions or requests posed by internal and external customers for approved Products/Brands and for products in development in accordance with Company Policies, and applicable laws, regulations and ethical standards, • Shares appropriate approved clinical/technical information in a timely manner with the appropriate functional teams and other internal personnel., • Utilizes advanced clinical and technical expertise in contacts with External Experts, in accordance with the strategy developed by the Company and Compliance Policies to further understand and gain insight into (1) diagnostic medical imaging patterns in prostate cancer (2) treatment guidelines and therapeutic advances in the oncology arena, (3) the needs and interests of Healthcare providers, and (4) the medical needs of patients, • Identies potential speakers for promotional programs and speaker training meetings, • Provides constructive feedback to speakers and Lantheus (e.g., Professional Promotions) regarding accuracy and delivery of approved presentations and adherence to Compliance Policies, • Fully understands and complies with Lantheus Pharmacovigilance SOPs regarding Adverse Events, • Identies potential investigators for investigator sponsored trials following approved processes, • PhD, PharmD or MD required, • 5+ years MSL experience preferred, • 7+ years total relevant industry/clinical experience including oncology, urology, or radiopharmaceuticals/medical imaging preferred, • Procient at translating approved scientic or clinical data into high quality medical information to help Healthcare providers best serve their patients, • Demonstrated leadership working in a team environment with the ability to communicate effectively with management, peers, and all cross-functional teams, • Highly motivated to achieve optimal results with a demonstrated record of growth and achievement, • Proven ability to successfully manage multiple tasks simultaneously and adapt to and communicate change, • Oncology and/or Radiopharmaceutical knowledge, including key scientic publications, • In-depth knowledge of a technical, scientic or clinical area, • Knowledge of clinical trial design and process, • Knowledge of principles and implications of pharmacoeconomic data, • Advanced knowledge of the US Healthcare System and the Medical Imaging industry, • Advanced Word, PowerPoint, and Excel skills Core Values The ideal candidate will embody Lantheus core values: • Let people be their best, • Respect one another and act as one, • Learn, adapt, and win, • Know someone's health is in our hands Actual base pay offered may vary depending on a number of factors such as job-related knowledge, skills and experience. Employees in this position are eligible for a discretionary performance-based cash incentive, and depending on the level of the role may be eligible for a discretionary annual equity award. Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage. Other offerings include life and disability benefits, pre-tax accounts, a 401(k) with company contribution, and a variety of other benefits. In addition, employees are eligible for a generous time off package including paid vacation, holidays, sick days, and paid parental leave. Interested candidates can apply at Lantheus.com. Applications for this position will be accepted until May 9, 2026. Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, disability, protected medical condition as defined by applicable state or local law, genetic information, or any characteristic protected under applicable federal, state, or local laws and ordinances. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at ___. Lantheus is an E-Verify Employer. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the ___ notice from the Department of Labor.

Other San Diego, CA 92093, United States Extended Deadline: Mon 3/30/2026 ___ UC San Diego values and welcomes people from all backgrounds. If you are interested in being part of our team, possess the needed licensure and certifications, and feel that you have most of the qualifications and/or transferable skills for a job opening, we strongly encourage you to apply. This position will remain open until a successful candidate has been identified. UCSD Layoff from Career Appointment: Apply by 02/19/2026 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor. Reassignment Applicants: Eligible Reassignment clients should contact their Disability Counselor for assistance. Primary Work Location: California Medical Facility, 1600 California Dr., Vacaville, CA 95687. This position acts as a regional floater to provide coverage at other CDCR institutions on a regular basis that may include overnight stays. UCSD Department of Psychiatry is one of the most innovative and productive academic departments in the country, offering challenging career opportunities in the diverse areas of advanced educational programs, cutting-edge research, and state-of-the-art clinical services. The department is committed to offering a dynamic learning environment and growing opportunities to its talented and dedicated employees. The UCSD Department of Psychiatry is contracted to provide Transitional Case Management Program (TCMP) services for the California Department of Corrections and Rehabilitations (CDCR). TCMP services are provided for eligible incarcerated persons under the jurisdiction of CDCR and the State Department of Mental Health. Under close supervision, the incumbent will work full time (M-F, 8 hours per day, with work start and end times varying between 6am-5pm) at various CDCR correctional facilities (prisons), throughout California as well as other regional institutions as directed by management within the Department of Psychiatry. Incumbent will work as a Benefit Worker (BW) managing full caseloads consisting of incarcerated persons releasing from CDCR institutions, who are: (1) potentially eligible for benefit entitlements {i.e., Medi-Cal, Social Security, and Veterans Affairs}, (2) diagnosed as having HIV/AIDS, (3) diagnosed as having a mental illness, and/or (4) incarcerated persons determined to be in need of community-based continuity of care upon release from incarceration, (i.e., hospice, hospital/acute care, skilled nursing/long-term care, in-patient mental health care, board & care/assisted living, in-home health care, dialysis, oxygen [intermittent and continuous], chemotherapy, medications, etc.). BW will determine potential benefit eligibility based on medical/mental disability, financial, and/or age. BW will assist in the benefit application process, will complete, and submit application for California State sponsored Medi-Cal benefits, Social Security, Supplemental Security Income (SSI), or Social Security Disability Income; and Veterans Affairs (VA) benefits. Act as a liaison with institutional and parole staff for cases that may require additional case management and collaborate on specific cases. * Four years of related experience, education/training, OR a Bachelor's degree in related area. * Must be eligible for clearance to visit and work inside the prisons and other CDCR facilities. * Ability to perform intake evaluations. * Assessment, problem-solving and critical-thinking skills. * Ability to work in a collaborative manner with a diverse client group. * Ability to work in a fast-paced environment managing large caseloads independently. * Demonstrated ability to use computer information systems and solid computer literacy skills. Knowledge and experience in utilizing computer word processing to formulate documents, email for communication with other professionals, knowledge of internet to access resources as needed for client care and own professional development. * Demonstrated accountability and excellent organizational skills to prioritize workload to promptly meet deadlines. * Experience in professional case management and/or work effectively, both independently and in a team environment, to follow through with superior attention to detail and to complete tasks in a timely manner by a specific deadline. * Ability to write concise, factual psychosocial notes, case summaries, coherent and timely reports. Demonstrated ability to communicate clearly and concisely in both written and oral form. Strong oral and written communication skills. * Experience working with community mental health resources, other mental health/recovery professionals, correctional and parole officers on behalf of clients. * Strong demonstrated ability to maintain strict confidentiality and use professional judgment when reporting information to clients, other professionals, and family members. * Excellent interpersonal skills with the ability to foster a good working relationship with a wide variety of people, using tact, diplomacy, confidentiality, and flexibility. Demonstrated ability to use professional judgment to interpret, clarify and problem solve in a stressful working environment. Ability to work independently and maintain professional boundaries. * Knowledge and understanding of clinical counseling principles, methods, procedures, and standards. * Master's degree in Social Work, Psychology, or related field. * Demonstrated knowledge of federal, state, and local laws related to health and social welfare. Solid experience assisting clients with Social Security Administration, Veteran's Affairs and Medicare/Medical. * Demonstrated knowledge and prior experience in professional case management and/or work with parolees/ex-offenders diagnosed with HIV/AIDS and/or Mental Illness. Casework experience must have included performing psychosocial assessments; developing benefit assistance, creating service plans; securing housing; conducting referral and follow-up progress evaluations. * Training and experience using motivational interviewing techniques with incarcerated populations. Knowledge of various psychological theories and appropriate techniques for working with incarcerated populations. Understanding of theories and etiology for clients with co-occurring disorders. * Experience with providing direct services to State Prison incarcerated populations including a thorough knowledge of prison culture, dynamics, and environmental risk factors. * Employment is subject to a criminal background check. * Must be eligible for CDCR clearance to visit and work inside the prisons and Fire Camps. * Must be willing to work full time in a minimum through maximum security state prison. * Must utilize safe and reliable transportation methods for all work-related travel, and be willing to travel to various prison sites. * TB screening test required annually. * Must be willing to travel to cover other correctional facilities (prisons), throughout the State of California and other regional institutions as directed by management, to fulfill the TCMP program needs which may include overnight stay(s). Pay Transparency Act Annual Full Pay Range: $74,416 - $108,409 (will be prorated if the appointment percentage is less than 100%) Hourly Equivalent: $35.64 - $51.92 Factors in determining the appropriate compensation for a role include experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. The Hiring Pay Scale referenced in the job posting is the budgeted salary or hourly range that the University reasonably expects to pay for this position. The Annual Full Pay Range may be broader than what the University anticipates to pay for this position, based on internal equity, budget, and collective bargaining agreements (when applicable). If employed by the University of California, you will be required to comply with our Policy on Vaccination Programs, which may be amended or revised from time to time. Federal, state, or local public health directives may impose additional requirements. If applicable, life-support certifications (BLS, NRP, ACLS, etc.) must include hands-on practice and in-person skills assessment; online-only certification is not acceptable. UC San Diego Health Sciences is comprised of our School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, The Herbert Wertheim School of Public Health and Human Longevity Science, and our Student Health and Well-Being Department. We have long been at the forefront of translational - or "bench-to-bedside" - research, transforming patient care through discovery and innovation leading to new drugs and technologies. Translational research is carried out every day in the hundreds of clinical trials of promising new therapies offered through UC San Diego Health, and in the drive of our researchers and clinician-scientists who are committed to having a significant impact on patient care. We invite you to join our team! Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached. To foster the best possible working and learning environment, UC San Diego strives to cultivate a rich and diverse environment, inclusive and supportive of all students, faculty, staff and visitors. For more information, please visit ___. The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law. For the University of California's Anti-Discrimination Policy, please visit: ___ UC San Diego is a smoke and tobacco free environment. Please visit ___ for more information. UC San Diego Health maintains a marijuana and drug free environment. Employees may be subject to drug screening. Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts an offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; or have filed an appeal of a finding of substantiated misconduct with a previous employer. a. "Misconduct" means any violation of the policies governing employee conduct at the applicant's previous place of employment, including, but not limited to, violations of policies prohibiting sexual harassment, sexual assault, or other forms of harassment, or discrimination, as defined by the employer. For reference, below are UC's policies addressing some forms of misconduct:

Other San Diego, CA 92093, United States Extended Deadline: Mon 3/30/2026 ___ UC San Diego values and welcomes people from all backgrounds. If you are interested in being part of our team, possess the needed licensure and certifications, and feel that you have most of the qualifications and/or transferable skills for a job opening, we strongly encourage you to apply. This position will remain open until a successful candidate has been identified. UCSD Layoff from Career Appointment: Apply by 12/03/2025 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor. Special Selection Applicants: Apply by 12/10/2025. Eligible Special Selection clients should contact their Disability Counselor for assistance. Primary Work Location: High Desert State Prison, 475-750 Rice Canyon Road, Susanville, CA 96127 UCSD Department of Psychiatry is one of the most innovative and productive academic departments in the country, offering challenging career opportunities in the diverse areas of advanced educational programs, cutting-edge research, and state-of-the-art clinical services. The department is committed to offering a dynamic learning environment and growing opportunities to its talented and dedicated employees. The UCSD Department of Psychiatry is contracted to provide Transitional Case Management Program (TCMP) services for the California Department of Corrections and Rehabilitations (CDCR). TCMP services are provided for eligible incarcerated persons under the jurisdiction of CDCR and the State Department of Mental Health. Under close supervision, the incumbent will work full time (M-F, 8 hours per day, with work start and end times varying between 6am-5pm) at various CDCR correctional facilities (prisons), throughout California as well as other regional institutions as directed by management within the Department of Psychiatry. Incumbent will work as a Benefit Worker (BW) managing full caseloads consisting of incarcerated persons releasing from CDCR institutions, who are: (1) potentially eligible for benefit entitlements {i.e., Medi-Cal, Social Security, and Veterans Affairs}, (2) diagnosed as having HIV/AIDS, (3) diagnosed as having a mental illness, and/or (4) incarcerated persons determined to be in need of community-based continuity of care upon release from incarceration, (i.e., hospice, hospital/acute care, skilled nursing/long-term care, in-patient mental health care, board & care/assisted living, in-home health care, dialysis, oxygen [intermittent and continuous], chemotherapy, medications, etc.). BW will determine potential benefit eligibility based on medical/mental disability, financial, and/or age. BW will assist in the benefit application process, will complete, and submit application for California State sponsored Medi-Cal benefits, Social Security, Supplemental Security Income (SSI), or Social Security Disability Income; and Veterans Affairs (VA) benefits. Act as a liaison with institutional and parole staff for cases that may require additional case management and collaborate on specific cases. * Four years of related experience, education/training, OR a Bachelor's degree in related area. * Must be eligible for clearance to visit and work inside the prisons and other CDCR facilities. * Ability to perform intake evaluations. * Assessment, problem-solving and critical-thinking skills. * Ability to work in a collaborative manner with a diverse client group. * Ability to work in a fast-paced environment managing large caseloads independently. * Demonstrated ability to use computer information systems and solid computer literacy skills. Knowledge and experience in utilizing computer word processing to formulate documents, email for communication with other professionals, knowledge of internet to access resources as needed for client care and own professional development. * Demonstrated accountability and excellent organizational skills to prioritize workload to promptly meet deadlines. * Experience in professional case management and/or work effectively, both independently and in a team environment, to follow through with superior attention to detail and to complete tasks in a timely manner by a specific deadline. * Ability to write concise, factual psychosocial notes, case summaries, coherent and timely reports. Demonstrated ability to communicate clearly and concisely in both written and oral form. Strong oral and written communication skills. * Experience working with community mental health resources, other mental health/recovery professionals, correctional and parole officers on behalf of clients. * Strong demonstrated ability to maintain strict confidentiality and use professional judgment when reporting information to clients, other professionals, and family members. * Excellent interpersonal skills with the ability to foster a good working relationship with a wide variety of people, using tact, diplomacy, confidentiality, and flexibility. Demonstrated ability to use professional judgment to interpret, clarify and problem solve in a stressful working environment. Ability to work independently and maintain professional boundaries. * Knowledge and understanding of clinical counseling principles, methods, procedures, and standards. * Master's degree in Social Work, Psychology, or related field. * Demonstrated knowledge of federal, state, and local laws related to health and social welfare. Solid experience assisting clients with Social Security Administration, Veteran's Affairs and Medicare/Medical. * Demonstrated knowledge and prior experience in professional case management and/or work with parolees/ex-offenders diagnosed with HIV/AIDS and/or Mental Illness. Casework experience must have included performing psychosocial assessments; developing benefit assistance, creating service plans; securing housing; conducting referral and follow-up progress evaluations. * Training and experience using motivational interviewing techniques with incarcerated populations. Knowledge of various psychological theories and appropriate techniques for working with incarcerated populations. Understanding of theories and etiology for clients with co-occurring disorders. * Experience with providing direct services to State Prison incarcerated populations including a thorough knowledge of prison culture, dynamics, and environmental risk factors. * Employment is subject to a criminal background check. * Must be eligible for CDCR clearance to visit and work inside the prisons and Fire Camps. * Must be willing to work full time in a minimum through maximum security state prison. * Must utilize safe and reliable transportation methods for all work-related travel, and be willing to travel to various prison sites. * TB screening test required annually. * Must be willing to travel to cover other correctional facilities (prisons), throughout the State of California and other regional institutions as directed by management, to fulfill the TCMP program needs which may include overnight stay(s). Pay Transparency Act Annual Full Pay Range: $74,416 - $108,409 (will be prorated if the appointment percentage is less than 100%) Hourly Equivalent: $35.64 - $51.92 Factors in determining the appropriate compensation for a role include experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. The Hiring Pay Scale referenced in the job posting is the budgeted salary or hourly range that the University reasonably expects to pay for this position. The Annual Full Pay Range may be broader than what the University anticipates to pay for this position, based on internal equity, budget, and collective bargaining agreements (when applicable). If employed by the University of California, you will be required to comply with our Policy on Vaccination Programs, which may be amended or revised from time to time. Federal, state, or local public health directives may impose additional requirements. If applicable, life-support certifications (BLS, NRP, ACLS, etc.) must include hands-on practice and in-person skills assessment; online-only certification is not acceptable. UC San Diego Health Sciences is comprised of our School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, The Herbert Wertheim School of Public Health and Human Longevity Science, and our Student Health and Well-Being Department. We have long been at the forefront of translational - or "bench-to-bedside" - research, transforming patient care through discovery and innovation leading to new drugs and technologies. Translational research is carried out every day in the hundreds of clinical trials of promising new therapies offered through UC San Diego Health, and in the drive of our researchers and clinician-scientists who are committed to having a significant impact on patient care. We invite you to join our team! Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached. To foster the best possible working and learning environment, UC San Diego strives to cultivate a rich and diverse environment, inclusive and supportive of all students, faculty, staff and visitors. For more information, please visit ___. The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law. For the University of California's Anti-Discrimination Policy, please visit: ___ UC San Diego is a smoke and tobacco free environment. Please visit ___ for more information. UC San Diego Health maintains a marijuana and drug free environment. Employees may be subject to drug screening. Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts an offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; or have filed an appeal of a finding of substantiated misconduct with a previous employer. a. "Misconduct" means any violation of the policies governing employee conduct at the applicant's previous place of employment, including, but not limited to, violations of policies prohibiting sexual harassment, sexual assault, or other forms of harassment, or discrimination, as defined by the employer. For reference, below are UC's policies addressing some forms of misconduct:

Job Details Dir/Sr. Medical Director, Clinical Development Job Code #: 26CLDEV-2 Status: Exempt, Full Time Reports to: VP, Clinical Development Department: Clinical Development Location: San Diego Headquarters, Hybrid Contact: About Us! Actio Biosciences, Inc., is a drug discovery and development company grounded in the science of precision medicine. Actio is developing a portfolio of drugs to modulate the activity of proteins responsible for rare diseases with the goal to also translate these findings into treatments for common diseases with shared underlying disorders. Actio has built an integrated discovery engine with deep human genetics, bioinformatics, and drug discovery expertise. Actio was founded in October 2021, and is funded by Canaan, Deerfield Management, Droia, EcoR1 and Euclidian Capital. Come join an exciting and rapidly growing team dedicated to discovering transformational therapies for patients with severe unmet medical needs. At Actio, our employees are passionate about their work and believe in the power of teamwork, collaboration, and mutual respect. Visit: About You! Reporting directly to the Vice President, Clinical Development, the Medical Director / Senior Medical Director, Clinical Development, will play a critical leadership role in advancing the clinical development strategy for one or more pipeline programs. In this highly visible role, you will serve as the Program Team Lead (PTL) for a clinical asset, providing medical and scientific leadership across multiple indications. You will be responsible for both the strategic design and operational execution of clinical development plans, while also fulfilling medical monitoring responsibilities. The ideal candidate brings prior experience from small to mid-sized biotechnology companies and deep expertise in rare diseases and/or neurology. You will partner closely with cross-functional development teams, senior leadership, investigators, and external partners to ensure rigorous, efficient, and patient-focused clinical development. This position offers a unique opportunity to contribute strategically and operationally in a dynamic biotech environment, helping shape innovative therapies for patients with high unmet medical needs. You will be responsible for: • Leading a cross-functional, matrixed development team across research and development as Program Team Lead, in close partnership with the program manager., • Developing, maintaining and executing the clinical development plan across multiple indications., • Designing clinical trials and authoring or reviewing key study and regulatory documents, including protocols, Investigator Brochures, IND submissions, Clinical Study Reports, and related materials., • Providing ongoing medical monitoring for clinical studies, including oversight of patient safety and signal direction., • Analyzing, interpreting, and presenting clinical data and study results to internal stakeholders and external audiences., • Monitoring and interpreting the competitive landscape to inform program strategy., • Supporting the identification and selection of clinical investigators and maintaining strong professional relationships as the Sponsor medical representative., • Identifying resource needs and supporting budget planning and personnel forecasting for clinical programs., • Proactively identifying program risks and partnering with the program manager to develop mitigation strategies., • Participating in the preparation of abstracts, manuscripts, and scientific presentations for external meetings., • Providing clear, timely program updates and communicating effectively with senior leadership., • Contributing to a collaborative, respectful, and patient-focused work environment., • Performing other duties as assigned. You have the following skills and qualifications: Education & Experience • MD required; active medical license preferred but not required., • Formal training in Neurology (residency and/or fellowship) with hands-on patient treatment experience., • Minimum of 5 years of drug development experience within a biotechnology or pharmaceutical company., • Demonstrated leadership experience on development project teams (e.g., core team member, sub-team leader)., • Prior experience serving as a medical monitor for clinical trials., • Experience in rare disease, neurology, and/or genetic disorders strongly preferred., • Experience addressing pediatric patient needs preferred., • Experience interacting with global regulatory agencies (FDA, EMA, or other health authorities) preferred. Knowledge & Skills • Strong knowledge of Good Clinical Practice (GCP) and regulatory requirements for investigational drug development., • Familiarity with FDA and/or EMA regulations, ICH guidelines, and global clinical development standards., • Ability to navigate complex scientific and business challenges in a cross-functional, matrixed environment., • Strong decision-making, problem-solving, organizational, and analytical skills., • Excellent written and verbal communication skills, with the ability to clearly convey plans, risks, and results to diverse stakeholders., • Deep understanding of translation medicine, biomarker development, clinical study design, and execution, biostatistics, data analysis, and scientific reporting., • Comfort working in a fast-paced, small company environment with evolving priorities and minimal direction. Why Actio? The work culture at Actio fully embraces teamwork, collaboration and mutual respect. We believe that our employees are our greatest asset, and we strive to create an inclusive and empowering environment where everyone feels valued and respected for who they are. We encourage our employees to bring their unique perspectives and experiences to the table and we believe that this diversity is what makes us stronger as a team. We invest in supporting our employees to succeed both at work and at home, and we believe that a good work-life balance is essential for everyone’s well-being. If you thrive in an environment where you are inspired by others and empowered to participate to your fullest potential alongside exceptionally talented and kind human beings - - -Actio is the place for you! We are committed to ensuring all employees, both current and future, receive fair and equitable pay. Base pay is one component of the total compensation package, and is determined within a range according to role, level, and location. This provides the opportunity for growth as you gain experience and develop within a role, while also allowing for differentiation based on performance. The base pay range for this role is between $260,000 to $350,000 and reflects our good faith estimate of the minimum and maximum target for the position as of the date of posting and may be modified in the future. The final base pay within the range will be determined by work location and additional factors, including job-related skills, experience, relevant education or training, and market demand for your expertise. Benefits programs offered include: • Medical, dental and vision insurance (employee premiums covered by Actio at 90%), • Health Savings Account with a rich employer contribution, • Flexible Savings Account for healthcare and dependent care, • Mental health and wellness benefits, • 401k plan participation, • Equity Incentive Plan participation (stock options), • Life/AD&D/ST and LT Disability Insurance (premiums covered by Actio at 100%), • Supplemental benefits including legal service, pet insurance and other optional coverage, • Weeklong winter holiday shutdown & generous paid time off and holiday policies, • And more! Details of participation in these benefit plans will be provided with an employment offer. Actio benefits and compensation programs are subject to eligibility requirements and other terms of the applicable plan or program. Actio is committed to building a diverse workforce and providing equal employment opportunities to all employees and applicants for employment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. The above is intended to describe the general content of, and requirements to perform this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. To apply, please send your CV/resume and cover letter by email to: , and reference Job Code #: 26CLDEV-2 in the subject field.

Job Description About The Oncology Institute (): Founded in 2007, The Oncology Institute (NASDAQ: TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI offers cutting-edge, evidence-based cancer care to a population of approximately 1.9 million patients, including clinical trials, transfusions, and other care delivery models traditionally associated with the most advanced care delivery organizations. With over 180 employed and affiliate clinicians and over 100 clinics and affiliate locations of care across five states and growing, TOI is changing oncology for the better. At The Oncology Institute, Nurse Practitioners and Physician Assistants are at the heart of our mission to deliver compassionate, patient-centered oncology care. Here, you'll work in a collaborative, values-driven environment where innovation, integrity, and empathy guide every decision. We empower you with the resources, support, and professional growth opportunities you need to make a real impact—while ensuring you're part of a team that's transforming cancer care through evidence-based, value-driven medicine. Base Salary with Opportunity for Semi-Annual Performance Bonuses Advanced Practice Provider Role: Performs physical examinations and treats common complications of cancer treatment, counsels patients and families and monitors patient progress. Works in collaboration with other health care team members, consulting and referring as appropriate, but retains responsibility for ongoing clinical management of the patient. Responsibilities include: • Ensure patient information, visit history, refer outs, lab follow-up, phone calls, and consults are carefully and completely documented in the electronic medical record., • Conducts in-depth interviews with patients and/or family, constructs comprehensive medical histories, performs initial and periodic physical examinations and explores patient's interpretation of health needs. Identifies and treats patients' diseases., • Directly performs or orders appropriate diagnostic studies and interprets finished results., • Develops and implements long and short-range treatment plans., • Performs procedures such as bone marrow biopsy., • Instructs and counsels patients and families regarding preventive care, medical problems, psychological problems, and use of prescribed treatments and drugs., • Writes orders to increase, decrease or change medication, subject to checking and countersigning by physician., • Identifies and records pertinent progress of patients, updating and summarizing charts, changing orders when appropriate and notifying the responsible physician of changes in the patient's condition., • Master's degree in nursing, • Possession of current certificate of completion from a Nurse Practitioner or Physician Assistant program, • Current and unrestricted license to practice., • Oncology experience preferred but not required., • National Certification required upon employment (Nurse Practitioners).Why Join Us?, • Attractive base compensation, bonus incentive, and benefits package., • Opportunity to work with a leading oncology team., • Supportive and dynamic work environment. The estimate displayed represents the typical wage range of candidates hired. Factors that may be used to determine your actual salary may include your specific skills, how many years of experience you have and comparison to other employees already in this role. Pay Transparency for salaried teammates$120,000—$180,000 USD

Job DescriptionCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. As a Manufacturing Supervisor, you will oversee the manufacturing team, ensuring cGMP-compliant production of biologic products for clinical trials. You will supervise daily operations, mentor staff, and collaborate with the Associate Director of Manufacturing to drive efficiency, quality, and regulatory adherence. Responsibilities · Supervise the manufacturing team, including Technicians, Associates (I-II, III, III-Lead), to ensure seamless execution of production tasks such as cell culture, media preparation, formulation, centrifugation, and freezing. · Ensure all manufacturing activities comply with cGMP standards, overseeing proper documentation, inventory management, and cleanroom operations. · Review and approve cGMP documentation, including batch records, logs, forms, and protocols, ensuring accuracy and adherence to Good Documentation Practices (GDP). · Monitor production processes, analyze data, and report on performance metrics to identify areas for improvement and ensure quality goals are met. · Coordinate with the Associate Director of Manufacturing to develop production schedules, allocate resources, and address operational challenges. · Lead training and mentoring of manufacturing staff, ensuring team competency in aseptic techniques, cGMP standards, and manufacturing procedures. · Oversee the initiation, investigation, and closure of deviations, CAPAs, and process improvements, ensuring timely resolution and documentation. · Author, review, and update standard operating procedures (SOPs) and other manufacturing documentation using the document change system. · Manage inventory, material transfers, and cleanroom setup/shutdown activities to support continuous manufacturing operations. · Facilitate cross-functional collaboration with Quality Control, Materials Management, and other departments to ensure production alignment with company objectives. · Lead special manufacturing and development projects as assigned by the Associate Director of Manufacturing. · Perform other duties as assigned to support manufacturing operations and company goals. Requirements · Bachelor’s degree in Biological Sciences, Biomedical Engineering, or related field; advanced degree preferred. · 6+ years of experience in a cGMP manufacturing environment, with at least 2-3 years in a supervisory or leadership role. · In-depth knowledge of cell culture, aseptic techniques, cGMP standards, and regulatory compliance in a biotech/pharma setting. · Proven expertise in Good Documentation Practices (GDP) and managing manufacturing documentation. · Experience leading deviation investigations, CAPAs, and process improvement initiatives. · Strong leadership and mentoring skills, with the ability to guide and develop a diverse manufacturing team. · Excellent organizational and problem-solving skills, with the ability to manage multiple priorities in a fast-paced environment. · Effective communication skills for cross-functional collaboration, training, and reporting to senior management. · Proficiency in data analysis, technical report writing, and presenting production metrics. · Ability to gown and work in classified cleanroom areas, ensuring compliance with ISO 7 standards. Work Environment / Physical Demands · Primarily cleanroom-based with required time in GMP spaces overseeing manufacturing operations and team activities. · Requires prolonged periods of standing, computer use for documentation and reporting, and full gowning in ISO 7 cleanroom. · May involve lifting materials or equipment up to 20 pounds. · Ability to navigate cleanroom and GMP environments for production oversight and staff training. Why Capricor?Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that’s transforming lives with every breakthrough. Come Work With Us!At Capricor, you’ll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies. Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which is @capricor.com. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason. Notice to Recruiting AgenciesCapricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job DescriptionCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. As a Manufacturing Associate I, you’ll be a vital part of Capricor’s efforts in delivering therapies for patients in need. Supporting critical clinical trials and exosome development, you’ll perform meticulous production tasks and documentation to uphold our quality and compliance standards. This role places you in a cleanroom environment, where precision and attention to GMP standards are essential. You’ll be instrumental in ensuring that each production step is performed with accuracy, ultimately contributing to Capricor’s therapeutic success. Responsibilities • Perform routine manufacturing tasks, including media preparation, cell culture, cell counting, formulation, centrifugation, and freezing., • Complete and ensure timely, accurate documentation in compliance with GMP standards across batch records, forms, and protocols., • Mentor fellow team members on cGMP documentation protocols to ensure the highest standards., • Plan, collect, analyze, and report on production data, maintaining comprehensive records and observations., • Author, revise, and maintain SOPs through Capricor’s document change system., • Oversee inventory, material transfers, and cleanroom procedures to support efficient GMP operations., • Prepare technical summaries, protocols, and reports to ensure full documentation of production activities., • Lead moderate-complexity CAPAs and assist with deviations and investigations to maintain quality assurance., • Take on special projects in manufacturing and development as required.Requirements, • Bachelor’s degree in Biomedical Engineering, Biological Sciences, or a related field., • 1-3 years of experience in a cGMP/cGTP manufacturing environment., • Solid laboratory experience in mammalian tissue culture, along with expertise in aseptic techniques., • Working knowledge of regulatory standards in biopharmaceutical or tissue banking industries., • Strong organizational skills and acute attention to detail within a fast-paced, dynamic setting., • Basic molecular biology and flow cytometry skills are a plus. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job DescriptionSalary: $78,000 - $90,000 annually. Exact compensation may vary based on skills and experience. About Artiva: Artiva is clinical-stage, publicly-traded biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers. Artivas lead program, AlloNK, is an allogeneic, off-the-shelf, non-genetically modified NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. AlloNK is delivered in the outpatient setting with no required hospitalization. AlloNK is currently being evaluated in three ongoing clinical trials for the treatment of B-cell driven autoimmune diseases. This includes two company-sponsored trials, one in systemic lupus erythematosus for patients with or without lupus nephritis, and a basket trial across autoimmune diseases (Rheumatoid Arthritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathies and Sjgrens Disease), as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases. Artivas pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers. Artiva was founded in 2019 as a spin out of GC Cell, formerly GC Lab Cell Corporation, a leading healthcare company in the Republic of Korea, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia and New Zealand) to GC Cells NK cell manufacturing technology and programs. Artiva is headquartered in San Diego, California. For more information, visit. Job Summary: The Materials Management & Logistics Associate II works with procurement, inventory, receipt and release of manufacturing and QC materials for our newly established manufacturing facility. This position works closely with Manufacturing, QC, and QA teams from Technical Operations as well as corporate procurement to understand their needs and priorities. Duties/Responsibilities: • Perform daily supply chain operations including shipping, receiving, record keeping/documentation, inventory management, and order processing of all materials for Artiva manufacturing and QC operations, • Assist laboratory personnel to ensure effective management of material to support in-house manufacturing operations, • Perform manufacturing materials kitting as needed, • Proficiency in ERP and paper-based receiving/inventory systems, • Maintain accurate records of receipt and release of materials, • Perform inventory counts of materials as needed, • Assist with revision of SOPs for supply chain/materials management processes as needed, • Ensure that all documentation and materials transactions are completed accurately and following Good Documentation Practices, • Preparation of outbound shipments, including preparation of records and preparation of goods for final shipment as needed, • Collaborate with internal departments to ensure proper shipping of regulated and non-regulated materials, work with external shipping agents and vendors to resolve issues as needed, • Assist in reconciliation of order discrepancies and follow up with purchasing, vendors and end users as needed, • Adhere to appropriate PPE and safety rules, • Assist in all other materials management and supply operations deemed necessary to complete organizational goals Requirements: • A minimum of 2 years of experience in a regulated shipping and receiving/materials management position, preferably in biotech or life sciences, • Familiarity with GMP/GDP regulations as related to Pharma/Biotech/ industries preferred, • Cold chain experiences (2-8C, -20C, -80C, and below -150C)., • Strong attention to detail and problem-solving skills, • Experience with ERP use a plus, • Proficiency in Microsoft Office and the ability to learn new applications quickly and easily, • Knowledge of various inventory management systems, • Good collaborative and team-oriented communication, • Experience in a dynamic, fast paced, growing environment, • May need to work with hazardous materials, • Must be able to lift, carry, push and/or pull 50 pounds of equipment or supplies In addition to a great culture, we offer: • A beautiful facility, • An entrepreneurial, highly collaborative, and innovative environment, • Comprehensive benefits, including:, • Medical, Dental, and Vision, • Group Life Insurance, • Long Term Disability (LTD), • 401(k) Retirement Plan, • Employee Assistance Program (EAP), • Flexible Spending Account (FSA), • Paid Time Off (PTO), • Company paid holidays, including the year-end holiday week, • Our recognition program, Bonus.ly, is where you can trade in points earned for things you want. If all this speaks to you, come join us on our journey!

Job Description Clinical Services Manager Reports to: Brand Manager Location: On-site store location Do you have a passion to train and coach team members to deliver a remarkable patient experience? Are you a role model and leader that advocates for your sales team? You will ensure that patients receive quality care by ensuring the store team that provides clinical services follow operational processes and meets their goals daily. About us: Stanton Optical is among the nation’s fastest growing, full-service retail optical centers. We are dedicated to offering customer service and quality eyewear at affordable prices to our patients. As a leading optical retailer, we offer some of the nation's most desirable optical brands. Our team members share and support the Vision, Mission and Values of our parent company, Now Optics. These include: Vision: Modernizing the eye care experience for all people Mission: Making eye care easy Values: iCARE • Integrity: We see integrity as building a foundation of trust with our customers, employees and stakeholders by communicating honestly, ensuring consistency and delivering on our commitments., • Collaboration: We see collaboration as combining the talents of a diverse group, offering proactive communication and being open-minded to new ideas., • Accountability: We see accountability as taking initiative, delivering our best in all we do, accepting responsibility for our actions and taking ownership of results., • Respect: We see respect as prioritizing human relationships, being present, connecting with transparency and empathy. Goals include: • Greet our patients as they enter the store, identify patients' needs to ensure an easy and memorable experience while providing information on products and services available, • Drive sales to exceed personal and store daily, weekly and monthly revenue goals while delivering outstanding customer service experience., • Resolve customer issues and increase customer satisfaction through proper troubleshooting and training of the team on troubleshooting techniques., • Provide supervision, direction and guidance to the Doctor’s Technicians regarding but not limited to Diagnostic Pre-Testing, Local Mode and Digital Refraction, Contact Lens care and executing all PEG clinical standards., • The role is responsible for ensuring all training guidelines, procedures, protocols, and certification requirements, and clinical standards developed by the Physicians Eyecare Group are being executed at the highest level., • Maintain accurate, detailed patient records while ensuring confidentiality and compliance with HIPAA standards., • Ensure store brand standards by performing basic housekeeping duties when necessary., • Coach and train Doctor Technicians and their cross-trained counterparts on the proper insertion and removal of contact lenses for new and existing contact lens wearers., • At least 1 year of retail management experience or experience in a clinical leadership role., • High school diploma or equivalent., • Strong communication skills and ability to work in a fast-paced, team environment., • Passion for exceptional customer/patient care and a willingness to mentor and train others., • Flexibility to adapt to changing business and schedule requirements., • Knowledge of MS Word, Google Docs, and other basic office tools. If you have a disability and believe you need a reasonable accommodation to search for a job opening or apply for a position, email with your request. This email address is not for general employment inquiries or correspondence. We will only respond to those requests that are related to the accessibility of the online application system due to a disability.

Job DescriptionDescription: The Drug Safety Manager (DSM) is responsible for study and compound level safety oversight across early and late-stage clinical programs in collaboration with internal medical monitors, multidisciplinary / cross-functional teams within the organization, and external CRO partners. This role ensures high quality safety data, compliant case management, and robust safety surveillance. Essential Duties and Responsibilities The responsibilities of this role include but are not limited to the following: Study and program safety oversight • Serve as safety lead for assigned clinical studies (Phase 1–3), partnering with Clinical Development, Clinical Operations, and CRO safety teams., • Provide safety input into protocols, informed consent forms, IB safety sections, safety management plans, and monitoring plans., • Oversee CRO performance in ICSR case processing, MedDRA and WHO Drug coding, and expedited/periodic reporting according to study plans and global regulations., • Review periodic line listings, case narratives, and coding outputs; identify trends, quality issues, and areas requiring corrective action., • Contribute to ongoing medical review/surveillance by preparing safety data summaries (e.g., line listings, frequency tables, figures) for internal safety reviews and signal meetings., • Support identification and characterization of potential safety signals in partnership with Sr. Safety Manager and medical monitors., • Work closely with internal medical monitors/physicians to support causality and seriousness assessments, especially for complex or medically significant cases., • Partner with Clinical Operations on SAE reporting expectations, site training content, and reconciliation between clinical and safety databases., • Contribute to the development, implementation, and maintenance of safety related SOPs, work instructions, and templates., • Assist in preparation for, and participation in, internal audits and health authority inspections involving safety and pharmacovigilance., • Bachelor’s degree in Nursing, Pharmacy, Public Health, Biomedical Sciences, or related healthcare/scientific field required., • Preferred: RN, PharmD, PA, or other clinical credential. Required • Solid understanding of global PV regulations and ICH GCP, including SAE/SUSAR reporting requirements and aggregate reporting., • Demonstrated experience with CRO oversight and review of case processing outputs, MedDRA coding, and safety documentation., • Strong analytical skills with ability to review and interpret clinical and safety data and identify trends., • Excellent communication and collaboration skills with the ability to work in a small, fast-paced, cross-functional environment., • High degree of proficiency with Microsoft Office Suite (Excel, PowerPoint, Word, Outlook), file sharing software, online conferencing applications, and comfort learning new systems and dashboards., • Experience supporting Phase 3 clinical programs and/or registrational intent trials., • Experience with safety database outputs and basic familiarity with signal detection tools or methodologies., • Prior exposure to inspections or audits involving PV., • Experience in an early-stage biotech or similarly dynamic environment. VIKING THERAPEUTICS Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Notice to Agency and Search Firm Representatives Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

Job DescriptionJanux Therapeutics is seeking a Director of FP&A to serve as a strategic finance partner for clinical organization. This role will lead budgeting, forecasting, and long‑range planning while ensuring financial systems, models, and data integrity scale with the organization. The ideal candidate brings deep FP&A experience in a biotech or life sciences environment, strong systems administration experience (Adaptive preferred), and experience planning and executing clinical trials (Oncology and/or Autoimmune preferred).ESSENTIAL FUNCTIONS AND RESPONSIBILITIES • Lead annual operating plans, rolling forecasts, and long‑range plans for clinical functions (including Regulatory and Quality)., • Develop and maintain clinical trial budgets, enrollment‑based forecasts, and scenario models (including timeline shifts, protocol amendments, and vendor changes)., • Partner with CMO and clinical operations to monitor trial spend, burn rates, and forecasts by identifying risks, opportunities, and mitigation strategies., • Support portfolio prioritization and investment decisions, translating clinical strategy into clear financial implications., • Act as system owner and administrator for Adaptive Insights, including model design, data governance, integration, user access, and reporting standards., • Build and maintain scalable financial models to support clinical programs, headcount, vendor spend, and long‑term planning., • Partner with IT, Accounting, and FP&A stakeholders to ensure data accuracy, system controls, and audit readiness., • Lead enhancements and continuous improvement initiatives as Janux grows, ensuring the system supports evolving business needs., • Review and interpret PO workbooks, vendor commitments, and accrual schedules to ensure forecasts align with actual obligations., • Help bridge FP&A forecasts with GAAP results, supporting variance analysis and management reporting., • Present financial insights and recommendations to senior leadership in a clear, concise, and decision‑oriented manner., • Contribute to building best‑in‑class finance processes in a fast‑growing clinical‑stage biotech environment., • Perform other duties as deemed necessary.EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS, AND ABILITIES, • Bachelor’s degree in Finance, Accounting, Economics, or related field., • 8–12+ years of FP&A experience, with significant exposure to biotech, pharma, or life sciences., • Hands‑on experience administering Adaptive Insights (or similar FP&A systems)., • Strong understanding of clinical trial budgeting, forecasting, and accrual concepts., • Advanced Excel and financial modeling skills., • Ability to operate effectively in a fast‑paced, evolving clinical‑stage company., • Experience supporting oncology or clinical-stage programs is highly desirable., • Prior accounting experience a plus.In addition to a competitive base salary ranging from $215,000 to $230,000, we offer stock options, restricted stock units, a stock purchase plan (ESPP) and a target bonus. Janux also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance may also be available.Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, internal equity, and work location.Job Type: Full-time Benefits:· Annual bonus program· Incentive stock option plan· 401k plan with flat non-elective employer contribution · Comprehensive medical insurance with 90-100% employer-paid premiums · Dental and vision insurance· HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity) · Unlimited PTO · Generous holiday schedule; includes summer and winter company shutdown · Relocation assistance Schedule:· Monday to Friday Work authorization:· United States (Required) Additional Compensation:· Annual targeted bonus % Work Location:· On site (San Diego, CA) EQUAL OPPORTUNITY EMPLOYER:Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity. Notice to Recruiters and Third-Party AgenciesThe Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Job DescriptionCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. The Senior Director, Quality Assurance & Quality Systems provides strategic and operational leadership for all quality activities supporting Capricor’s clinical-stage and advancing commercial-stage organization. This role has full accountability for the design, execution, and continuous improvement of the Quality Management System (QMS) to ensure sustained regulatory compliance, inspection readiness, and robust quality oversight across development, manufacturing (including cell therapy production), and potential commercialization of Deramiocel and StealthX™-based programs. The Senior Director partners closely with executive leadership, Regulatory Affairs, CMC, Clinical, Manufacturing, and other cross-functional teams to enable late-stage development, BLA submissions and responses (including addressing any quality-related aspects of the Deramiocel pathway), commercial readiness, and scalable growth while embedding a proactive, risk-based quality culture across the enterprise.Responsibilities • Define and execute the enterprise quality strategy aligned with late-stage clinical development, BLA/regulatory submissions, potential commercial launch, and post-approval lifecycle management for cell and exosome-based therapies., • Serve as the senior Quality leader and strategic advisor to executive and operations management on compliance matters, inspection readiness, quality risk management, and GxP expectations in a biotech environment., • Own and continuously enhance the enterprise QMS to support clinical, manufacturing, and commercial operations, including Document Control and Change Management, Deviations/Investigations/CAPA, Training and Qualification, Data Integrity and Records Management, and other core quality processes., • Ensure quality systems are phase-appropriate, scalable, efficient, and fully aligned with FDA GMP regulations (21 CFR Parts 210/211, 820, and biologics-specific guidance), ICH guidelines, ISO standards, and global expectations for advanced therapies., • Ensure ongoing compliance with FDA, GMP, and applicable global regulations for clinical trials, manufacturing, and potential commercial activities, including cell therapy and exosome platforms., • Lead preparation for, management of, and response to regulatory inspections (including PAIs), partner audits, and health authority interactions; act as the primary Quality representative during agency engagements and inspections., • Provide comprehensive quality oversight for clinical quality assurance, including GCP compliance and support for ongoing trials such as HOPE-3 extensions or related activities., • Oversee quality support for manufacturing, testing, process validation, technology transfer, comparability studies, and supply chain activities for late-stage and commercial products (e.g., Deramiocel cell therapy production)., • Ensure timely and effective resolution of quality events, deviations, CAPAs, complaints, and out-of-specification results, with appropriate escalation, root cause analysis, and management visibility., • Collaborate closely with Clinical, Regulatory Affairs, CMC/Process Development, Manufacturing, Supply Chain, Quality Control, and Commercial teams to integrate quality principles throughout the product lifecycle and enable efficient, compliant decision-making., • Establish, monitor, and report quality KPIs, trends, risk indicators, and compliance metrics to senior leadership and the Quality Management Review., • Drive continuous improvement initiatives, including process optimizations, lessons learned from inspections/audits, and enhancements to strengthen compliance maturity, operational efficiency, and inspection outcomes., • Build, lead, and mentor a high-performing QA and Quality Systems organization; develop talent, succession plans, and training programs to support organizational scaling and commercialization milestones., • Foster a collaborative, accountable, and inspection-ready mindset across the quality team and broader company.Requirements, • Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or a related field; advanced degree (e.g., MS, PhD) preferred., • 12+ years of progressive Quality Assurance experience in pharmaceutical or biotechnology environments, with significant focus on biologics, cell therapies, or advanced therapy medicinal products., • 7+ years of senior leadership experience with direct ownership and oversight of enterprise Quality Management Systems in a growing organization., • Hands-on experience supporting late-stage clinical programs, BLA submissions, pre-approval inspections (PAIs), and commercial readiness/launch activities for regenerative medicine or biologics products., • Deep knowledge of FDA regulations (including 21 CFR Parts 210/211, 820, biologics-specific guidance), GMP, ICH guidelines (Q8-Q12, etc.), and global standards relevant to cell and exosome therapies., • Demonstrated success leading regulatory inspections (PAIs, routine GMP inspections), responding to findings, and maintaining inspection readiness in dynamic settings., • Proven ability to scale QMS and quality organizations in a rapidly growing biotech company preparing for commercialization., • Strong executive presence with the ability to influence, collaborate with, and advise cross-functional teams and senior leadership., • Excellent communication, problem-solving, decision-making, and strategic thinking skills.Work Environment / Physical Demands, • Office-based with routine presence in GMP manufacturing and laboratory environments to support oversight, audits, inspections, and quality activities., • Extended periods of computer use for documentation review, data analysis, metrics reporting, and quality system management., • Occasional lifting of office or light materials up to 10 pounds. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job Description Job Summary: The Associate Director, GxP Quality Systems is responsible for the development, implementation, and ongoing management of the company’s Quality Management System (QMS) supporting GxP activities. This role ensures that quality processes and systems effectively support compliant operations across clinical, regulatory, and operational functions. Key Responsibilities: GXP Quality Management System Oversight • Develop, implement, and maintain the company’s GxP Quality Management System supporting clinical development and broader GxP activities., • Provide governance for core quality processes including document management, training administration, and quality event processes (e.g., deviations, change control, and CAPA)., • Ensure quality policies, procedures, and standards support compliance with applicable GXP regulations, guidelines, and other relevant regulatory requirements., • Maintain oversight of electronic quality management systems (eQMS), including administration, configuration, and alignment with company quality processes., • Monitor the effectiveness of quality processes and drive continuous improvement initiatives within the QMS., • Develop and maintain quality metrics and dashboards to evaluate compliance trends and system performance., • Provide guidance and training to internal teams on quality system processes and expectations., • Collaborate with clinical operations, regulatory, CMC, and other functional teams to support implementation of quality processes., • Collaborate with the GMP and GCP Quality functions to support quality oversight of manufacturing and clinical development activities., • Support the development and maintenance of clinical quality procedures and standards., • Assist with inspection readiness activities related to manufacturing, clinical trials and regulatory inspections., • Support internal and external audit programs, including preparation, coordination, and follow-up activities., • Participate in vendor qualification and oversight activities where quality system processes are involved., • Bachelor’s degree in a scientific discipline or related field., • 6+ years of progressive experience in Quality Assurance or Quality Systems within the pharmaceutical or biotechnology industry., • Experience supporting clinical development programs and familiarity with GMP and/or GCP regulations and guidelines., • Experience working with electronic Quality Management Systems (e.g., Veeva, TrackWise, or similar platforms)., • Experience working in a virtual or outsourced development environment is preferred., • Strong organizational, analytical, and problem-solving skills. The company provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Recruiters and Agencies: BlossomHill Therapeutics does not accept unsolicited referrals or resumes from any source other than directly from candidates. We will not consider unsolicited referrals and/or resumes from vendors including and without limitation, search firms, staffing agencies, fee-based referral services and recruiting agencies. The submission of referrals or resumes by anyone other than a candidate directly to BlossomHills’ employees is strictly prohibited. Unsolicited referrals and resumes sent to BlossomHill Therapeutics are deemed gratuitous, and the company will not be obligated or bound in any way to pay any referral or other fee if a person referred to us from a source other than a candidate is hired.

Job Description Position: In Vivo Research Associate II, Large Animal Pay Rate: $28 - $32 /hr Location: Carlsbad, CA About Pharmaron Pharmaron is a global CRO (Contract Research Organization) helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK and China, we support drug discovery through to manufacturing with fully integrated, high-quality services. We're proud of the impact we make and just last year, we supported over 780 discovery projects, 1,000+ CMC programmes, and 1,000+ clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,000 global customers. To learn more, visit . Job Overview: Pharmaron (San Diego) is seeking to hire an outstanding candidate to join our Medical Device department at the Research Associate II level. The Research Associate will play an important role by supporting in vivo studies to test medical devices. This position requires a broad knowledge of animal anatomy, physiology, and biochemistry to help develop and support in vivo models to screen therapeutics and devices being developed for various indications. Responsibilities: • Experience in the administration of test substances by various basic methods (i.e., oral gavage, SQ, IV, dermal, etc.), • Manage and observe animals for general health and overall wellbeing., • Experience in the collection of biological specimens (i.e., blood from appropriate vessels from all species of laboratory animals at the site), • Able to perform study related activities in compliance with Good Laboratory Practice Regulations (GLPs), study protocols, and company policies and Standard Operating Procedures (SOPs), • Review documentation to ensure functions performed meet quality control requirements., • Handle, restrain, and provide care for all species of laboratory animals at the site., • Perform study preparation activities, including collection tube labeling and room setup., • Perform catheter placements in large animals., • Perform surgical procedure: intubation, anesthesia, pain recognition and analgesia., • Monitor animals under anesthesia and during post-operating monitoring and recovery., • Perform biopsies and skin excisions., • Perform necropsies and tissue collection., • Interface with different teams, including study director, principal investigator, QC/QA, and Account Managers/Sales., • Maintain accurate records in various internal databases., • Support internal research projects to optimize service offerings. Perform aseptic techniques., • We're seeking individuals who have strong communication skills with attention to detail who thrive in fast-paced environments., • Associates degree (preferred) in veterinary technology with 3 years relevant experience., • BS with at least 2 years relevant experience., • Education level requirements could be amended based on relevant years of experience., • Certification as a registered veterinarian technician (RVT) is a plus., • Working knowledge of preclinical techniques and modalities will be a plus., • Position requires good communication skills and attention to detail. Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China. Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators. Benefits: As part of our commitment to your well-being, we offer a comprehensive benefits package: • Insurance including Medical, Dental & Vision with significant employer contributions, • Employer-funded Health Reimbursement Account, • Healthcare & Dependent Care Flexible Spending Accounts, • 100% Employer-paid Employee Life and AD&D Insurance, Short and Long Term Disability Insurance, • 401k plan with generous employer match Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today! As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences. #LI-MC1

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Senior Manager of Clinical Standards & Processes (CS&P) will act as the internal TMF lead on all studies, ensuring oversight to outsourced TMF work (vendor and/or CRO) and performing oversight to TMF metrics and trends. In addition, the Senior Manager of CS&P may be tasked with projects that ensure proper framework of TMF related processes and ongoing compliance to Standard Operating Procedure/ Work Instruction (SOP/WI) and Good Clinical Practice (GCP)/Good Documentation Practice (GDP). The primary purpose of the position is to oversee the eTMF process and vendor, ensure compliance with GCP and consistency across the programs, and to provide guidance and best practices to Clinical Operations. Responsibilities • Ensure staff is provided GCP/SOP/WI training for Clinical Operations staff and refreshers where applicable., • Provide leadership, guidance and oversight on study related issues pertaining to the eTMF, and company processes., • Ensure the collection of metrics and tracking systems to facilitate a proactive, risk-based quality management, • Assist Associate Director with eTMF system administration functions (CS&P is the business owner of the eTMF system)., • Manage eTMF and Study TMF training for internal and external user access., • Oversee CS&P role in eTMF user access process in accordance with applicable SOP/WI and escalate issues as required to Senior Management, • Direct junior CS&P staff with eTMF set-up, maintenance, ongoing quality control review, and final reconciliation of study, • Oversee clinical vendor management and escalate issues as required to Senior, • Collaborate with Quality Assurance on health authority inspection preparation activities and provide leadership and oversight during, • Collaborate with Quality Assurance with the preparation, conduct and response to internal and external audits/inspections, as applicable., • Facilitate ongoing quality improvement through communication of audit results, CAPAs and GCP guidance and consultation to COM and Senior Management, as, • Contribute to the development of Clinical Operations documents (forms, templates, SOPs/Wls)., • Ensure consistency and standardization of processes across Clinical Operations., • Collaborate with other cross functional areas (Safety, Regulatory, Legal, Finance, Project Management and QA) to ensure operational, • Support the Associate Director of CS&P and Clinical Operation Senior Management in leading various process improvement initiatives., • Minimum of 8 years of relevant experience in clinical operations/clinical quality or quality assurance role/ minimum of 2 years in a managerial or lead role/ minimum of 3 years in TMF experience (preferred)., • Minimum 2 years Veeva eTMF experience in a management role., • Fundamental knowledge of US, EU and international regulatory standards and guidelines for the conduct of clinical trials (ICH GCP, FDA; EMA; ANZ regulations), • Experience in inspection, • Bachelor's degree in a Science discipline, • Knowledge of industry compliance trends All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Job Description The Vice President of Quality will establish, lead and develop the quality function, in line with the company’s stage, while ensuring global regulatory, industry, and corporate standards are met. Reporting to the Senior Vice President of Regulatory Affairs this position will ensure the organization's compliance with the highest standards, including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GPV). This is a hands-on, strategic, and leadership role, ideal for a seasoned Quality executive passionate about small-molecule therapeutics in a dynamic biotech environment. Key Responsibilities: • Oversee GXP and Data Integrity activities across various entities, investigator sites, clinical and nonclinical studies, PV vendors, and CROs, • Maintain efficient systems and processes that ensure Contineum and its vendor network comply with GXP standards, • Ensure the appropriate identification, evaluation, and management of risks associated with quality, • Maintain and continuously improve the Quality Management System, providing guidance and strategic direction for GxP quality standards and their deployment., • Build strong relationships with stakeholders, representing the company's interests and ensuring compliance with all relevant regulations, • Work closely with cross-functional teams to ensure that quality considerations are incorporated throughout the product development lifecycle, • Ensure the timely and effective resolution of quality issues and deviations, working collaboratively with internal and external teams to implement corrective and preventive actions, • Lead the quality review process, ensuring the effective review and approval of batch records, release testing, and other quality-related documentation, • Create and implement risk-based quality strategies that identify and address potential quality risks, • Manage quality-related activities related to manufacturing, clinical trials, and nonclinical studies, including conducting audits of vendors and sites, providing support during health authority inspections, and offering guidance on quality issues, • Ensuring vendors adhere to relevant quality programs, regulations, and guidelines, and preparing them for regulatory inspections, • Overseeing the development, implementation, and upkeep of quality systems and procedures, training records, batch records, quality metrics, standard operating procedures (SOPs) pertaining to GXP and PV activities, • Lead quality investigations and approve plans to address quality issues that impact products, as well as supervising corrective and preventive actions (CAPAs) for deviations and investigations, • Stay updated on industry developments, regulations, guidance, and best practices, and providing training and mentoring on global GXP/PV regulations and guidance, • Ensuring preparedness for pre-approval and routine regulatory inspections conducted by global Regulatory Health Authorities, • BS/BA in biology or related Life Sciences discipline, or equivalent experience, • Minimum of 15 years of experience with increasing responsibilities, including leadership of a Quality function with a focus on biotech or pharmaceutical product development, • Strong working knowledge of global regulatory requirements, including GMP, GCP, and ICH guidelines, • Expertise in Quality Management Systems (QMS), • Extensive knowledge of quality risk assessment and management methodologies, with a successful track record in their application and risk mitigation, • Proven experience in establishing and managing a quality organization and GXP and CSV experienced team members, • Track record of success in a biotech start-up or fast-paced, innovative, dynamic environment, with the ability to remain flexible, proactive, resourceful, and efficient, • Ability to handle multiple projects simultaneously and to prioritize tasks in a dynamic environment, • Strong management, interpersonal, and communication skills, with a history of effectively collaborating with senior scientific, medical, and operations staff, • Demonstrated ability to lead and motivate cross-functional teams, • Willingness and desire to “roll up your sleeves” and perform activities and responsibilities to support the team We offer a competitive total compensation package, as well as working in a supportive team environment. The anticipated salary range for candidates is $300,000- $350,000. 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 within the job, type and length of experience within the industry, education, etc. Contineum offers competitive compensation and benefits, including: • 90% employer-covered benefits, • Flexible PTO, • A very generous holiday schedule that includes a week off in August and time off around the winter holidays, • A well-stocked kitchen with snacks and beverages, • Additional benefits include the opportunity for annual bonuses, stock options, an Employee Stock Purchase Program, and a 401(k) with an employer match., • The comprehensive wellness program includes medical, dental, vision, and LTD coverage.

Job Description Job Summary: The Clinical Trial Manager/Senior Clinical Trial Manager will lead the operational execution of clinical trials from start-up through close-out. This role is responsible for CRO and vendor oversight, study planning, timeline and budget management, and ensuring trials are conducted in compliance with regulatory requirements, ICH/GCP guidelines, and internal SOPs. The CTM/Senior CTM will proactively manage risks to ensure delivery of high-quality clinical data within timelines and budget. This role is an on-site position. Key Responsibilities: • Participate in vendor selection processes including RFP development, vendor evaluation, and contract scope development., • Develop and maintain good working relationships with CRO, investigators and study staff., • Ensure studies are conducted according to the study protocol, SOPs, and ICH/GCP regulations, • Develop and maintain study timelines and operational plans; track study milestones and proactively identify and mitigate risks to study delivery., • Lead study start-up activities including site feasibility, site selection, site activation planning, and oversight of IRB/EC submissions., • Implement and oversee risk-based monitoring strategies and centralized data review activities to proactively identify study risks and ensure data integrity., • Perform high-level clinical data review of listings and summary tables to identify trends, data issues, and potential protocol deviations., • Ensure timely response to data queries and monitoring discrepancies. Assist with third-party vendor training on protocols and practices., • Develop and present study operational metrics and status updates to internal leadership and study governance teams., • Track and report on study progress including site activation, patient enrollment, monitoring activities, and data entry backlogs, and escalate risks to study timelines as appropriate., • Oversee investigational product (IP) accountability, supply management, and reconciliation activities. Oversee the performance of CROs and third-party vendors, including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to Clinical Operations Managers., • Support study budget management including vendor budget tracking, forecasting, and review of change orders to ensure study execution within financial targets., • Perform initial review of CRO and other third-party study vendor invoices for correctness., • Review and/or approve IP release packages., • Contribute to the preparation of clinical protocols, amendments, informed consent forms, study manuals and guides, electronic case report forms, and any other clinical research related documents., • Ensure ongoing inspection readiness and support regulatory authority inspections (e.g., FDA, EMA) as required., • Participate in the planning of quality assurance activities, coordinating the resolution of applicable audit findings., • Ensure audit-ready condition of clinical trial documentation including clinical trial master files; review monitoring visit reports to ensure quality and resolution of site-related issues; coordinate and assist in the planning of regulatory or ethics committee activities, as appropriate., • Lead cross-functional study teams including Data Management, Biostatistics, Regulatory Affairs, Medical, and Pharmacovigilance to ensure alignment on study deliverables., • Prepare and/or review study-related documents (e.g., Study Plan(s), Laboratory Manual, Patient Diary, Pharmacy Manual, CRF Completion Guidelines, etc.)., • Prepare/review site study documents (i.e., site-specific informed consent, study tools/worksheets, investigator contracts, and site payments)., • Manage clinical monitoring activities (including approval of visit report templates, monitoring plan, etc.) ensuring compliance with ICH/GCP and applicable regulations, including the management through resolution (e.g. CAPA) of any site or study level issues, deviations, etc., • Undergraduate degree in life sciences related field. Graduate degree preferred., • Therapeutic experience in oncology is strongly preferred., • Experience managing clinical trials, preferably as the sponsor., • Clinical Trial Manager – 5+ years, • Senior Clinical Trial Manager – 7–10+ years, • Thorough knowledge of clinical research concepts, practices, FDA regulations and ICH guidelines regarding drug development and data management methods., • Experience monitoring sites and conducting other site management activities., • Experience working with clinical trial systems such as EDC, and eTMF, and IVRS., • Ability to work in a fast-paced environment and flexibility, • Proven experience in early phase clinical trials., • Strong site management and CRO management skills required. The company provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Recruiters and Agencies: BlossomHill Therapeutics does not accept unsolicited referrals or resumes from any source other than directly from candidates. We will not consider unsolicited referrals and/or resumes from vendors including and without limitation, search firms, staffing agencies, fee-based referral services and recruiting agencies. The submission of referrals or resumes by anyone other than a candidate directly to BlossomHills’ employees is strictly prohibited. Unsolicited referrals and resumes sent to BlossomHill Therapeutics are deemed gratuitous, and the company will not be obligated or bound in any way to pay any referral or other fee if a person referred to us from a source other than a candidate is hired.

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Senior Manager of Clinical Standards & Processes (CS&P) will act as the internal TMF lead on all studies, ensuring oversight to outsourced TMF work (vendor and/or CRO) and performing oversight to TMF metrics and trends. In addition, the Senior Manager of CS&P may be tasked with projects that ensure proper framework of TMF related processes and ongoing compliance to Standard Operating Procedure/ Work Instruction (SOP/WI) and Good Clinical Practice (GCP)/Good Documentation Practice (GDP). The primary purpose of the position is to oversee the eTMF process and vendor, ensure compliance with GCP and consistency across the programs, and to provide guidance and best practices to Clinical Operations. Responsibilities • Ensure staff is provided GCP/SOP/WI training for Clinical Operations staff and refreshers where applicable., • Provide leadership, guidance and oversight on study related issues pertaining to the eTMF, and company processes., • Ensure the collection of metrics and tracking systems to facilitate a proactive, risk-based quality management, • Assist Associate Director with eTMF system administration functions (CS&P is the business owner of the eTMF system)., • Manage eTMF and Study TMF training for internal and external user access., • Oversee CS&P role in eTMF user access process in accordance with applicable SOP/WI and escalate issues as required to Senior Management, • Direct junior CS&P staff with eTMF set-up, maintenance, ongoing quality control review, and final reconciliation of study, • Oversee clinical vendor management and escalate issues as required to Senior, • Collaborate with Quality Assurance on health authority inspection preparation activities and provide leadership and oversight during, • Collaborate with Quality Assurance with the preparation, conduct and response to internal and external audits/inspections, as applicable., • Facilitate ongoing quality improvement through communication of audit results, CAPAs and GCP guidance and consultation to COM and Senior Management, as, • Contribute to the development of Clinical Operations documents (forms, templates, SOPs/Wls)., • Ensure consistency and standardization of processes across Clinical Operations., • Collaborate with other cross functional areas (Safety, Regulatory, Legal, Finance, Project Management and QA) to ensure operational, • Support the Associate Director of CS&P and Clinical Operation Senior Management in leading various process improvement initiatives., • Minimum of 8 years of relevant experience in clinical operations/clinical quality or quality assurance role/ minimum of 2 years in a managerial or lead role/ minimum of 3 years in TMF experience (preferred)., • Minimum 2 years Veeva eTMF experience in a management role., • Fundamental knowledge of US, EU and international regulatory standards and guidelines for the conduct of clinical trials (ICH GCP, FDA; EMA; ANZ regulations), • Experience in inspection, • Bachelor's degree in a Science discipline, • Knowledge of industry compliance trends All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Job DescriptionSalary: About Artiva: Artiva is clinical-stage, publicly-traded biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers. Artivas lead program, AlloNK, is an allogeneic, off-the-shelf, non-genetically modified NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. AlloNK is delivered in the outpatient setting with no required hospitalization. AlloNK is currently being evaluated in three ongoing clinical trials for the treatment of B-cell driven autoimmune diseases. This includes two company-sponsored trials, one in systemic lupus erythematosus for patients with or without lupus nephritis, and a basket trial across autoimmune diseases (Rheumatoid Arthritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathies and Sjgrens Disease), as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases. Artivas pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers. Artiva was founded in 2019 as a spin out of GC Cell, formerly GC Lab Cell Corporation, a leading healthcare company in the Republic of Korea, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia and New Zealand) to GC Cells NK cell manufacturing technology and programs. Artiva is headquartered in San Diego, California. For more information, visit. Job Summary: Reporting to the Senior Manager, Biomarker Operations, the Manager, Biomarker Operations is responsible for managing operational aspects of the clinical biomarker projects. This position will be responsible for managing the biomarker operation of Artivas clinical studies by coordinating sample-related operations with Clinical Operations, contract executions, and communication between the Translational Science group with external contract research organizations (CRO) and internal lab personnel. The successful candidate will have strong communication and project management skills. Understanding and experience with drug development and clinical trial process is a prerequisite for this position. Duties/Responsibilities: • Oversee day-to-day biomarker operations of Artivas clinical trials including but not limited to execution of biomarker operations with external vendors, ensuring CROs meet all key deliverables and timelines, • Working closely with the translational leads, manages documentation and performance of biomarker assays conducted at CROs, ensures timely delivery of high-quality biomarker data, and supports CRO audits, • Ensures timely collection kit preparation and sample testing database builds including review of required documentation, • Works with Clinical Operations and CRO to prepare for site activations including preparation of training materials, • Manages collection kit logistics, sample inventory, and sample testing at CROs; tracks and follows up on discrepancies and missing information, • Coordinates shipping and testing scheduling with central lab or 3rd party vendors, • Contributes to data transfer specifications review and implementation, • Assist the internal biomarker laboratory with sample shipping and receiving, • Contributes to translational logistics meetings Requirements: Must thrive working in a fast-paced innovative environment while remaining flexible, proactive, and efficient. Excellent communication, project management and interpersonal skills. Able to develop important relationships with key internal stakeholders and external entities. • Bachelors or Master's degree in biology, immunology, or related fields and/or project management experience is required with a minimum of 6 - 8 years experience within the biotechnology or pharmaceutical industry, • Demonstrated experience of managing biomarker sample operation of clinical trials, working with CROs to execute biomarker study plan., • Excellent communication skills, verbal and written, • Understanding and experience with drug development and clinical trial process Competencies • Time Management, • Risk Management, • Operations Management, • Finance, • Business Planning, • Implementing Plans, • Analysis and Reporting, • Negotiation Attributes • Honesty/Integrity, • Communication skills, • Self-starter, • Forward thinking, • Creative/imaginative, • Confident, • Self-controlled, • Intuitive, • Positive, • Committed, • Ambitious/driven, • Agile, • Collaborative, • Transparent In addition to a great culture, we offer: • A beautiful facility, • An entrepreneurial, highly collaborative, and innovative environment, • Comprehensive benefits, including:, • Medical, Dental, and Vision, • Group Life Insurance, • Long Term Disability (LTD), • 401(k) Retirement Plan, • Employee Assistance Program (EAP), • Flexible Spending Account (FSA), • Paid Time Off (PTO), • Company paid holidays, including the year-end holiday week, • Our recognition program, Bonus.ly, is where you can trade in points earned for things you want. If all this speaks to you, come join us on our journey! Base Salary: $130,000 - $142,000. Exact compensation may vary based on skills and experience.

Job DescriptionSalary: Vert Competative and well above market Physician Assistant Pain Management & Urology Experience High-Income Potential | Procedure-Focused | Growth-Oriented Practice Location: San Diego Position Type: Part time/Full-Time Compensation: $160,000 $200,000+ (Base + Production + Bonuses) Build a High-Income Career in Advanced Pain & Neuromodulation We are actively recruiting a top-performing Physician Assistant with and Urology experience who wants more than just a job this is a career-building opportunity in a rapidly expanding interventional pain practice. If you are confident in neuromodulation, comfortable managing complex pelvic pain and urologic conditions, and motivated by production-based earnings, this position offers exceptional upside. This is not an entry-level role. We are looking for a skilled, independent clinician who can contribute immediately. Compensation Designed for High Performers • Strong Guaranteed Base Salary: $160,000 $180,000 (DOE), • Aggressive Productivity Bonus Structure, • Procedure-Based Incentive Pay (InterStim trials & implants), • Annual Income Potential: $200K+ for productive providers, • CME allowance, • Full benefits package, • Malpractice covered What Youll Be Doing Advanced Clinical Management • Evaluate and manage chronic pain and pelvic pain patients, • Diagnose and treat overactive bladder, urinary retention, IC, and complex urologic conditions, • Independently manage follow-ups and treatment plans, • Evaluate candidates for sacral neuromodulation, • Perform or assist with InterStim trials and permanent implants, • Device programming and troubleshooting, • Work alongside interventional pain physicians, • Assist in advanced procedures as needed, • PA-C with active license and DEA, • 2+ years experience in Pain Management or Urology, • Direct InterStim experience REQUIRED, • Comfortable in a procedural environment, • Strong clinical confidence and decision-making ability, • Established referral network, • Procedure-heavy environment, • Leadership that supports autonomy, • Real earning potential (not capped RVUs) Ideal Candidate Profile You thrive in: • High-performance environments, • Procedure-based income models, • Collaborative but autonomous practice settings, • Building long-term patient relationships, • Expanding advanced neuromodulation services

Job Description Job Description: We are seeking an experienced, collaborative, and strategic physician leader with deep expertise in obesity and metabolic disease clinical development to help build and execute the clinical vision for the Company’s portfolio. This role will be responsible for defining and driving clinical strategies across early- and late-stage development programs, with a particular focus on obesity, cardiometabolic, and related metabolic indications. The Senior Director, Clinical Development (MD) will play a critical leadership role in advancing innovative therapies through the clinic, combining scientific rigor, regulatory insight, and operational excellence. The ideal candidate brings a strong track record of leading obesity and metabolic clinical trials, working cross-functionally, and delivering high-quality clinical outcomes in a fast-paced biotech environment. Essential Responsibilities: Clinical Strategy & Leadership • Lead the development and execution of clinical development strategies for obesity and metabolic disease programs across multiple stages of development., • Provide medical and scientific leadership for clinical trial design, execution, and interpretation, including endpoint selection, patient populations, safety monitoring, and benefit–risk assessments., • Serve as the primary medical expert for obesity/metabolic programs, advising internal teams, investigators, consultants, business development partners, and investors., • Champion clinical excellence and accountability across all assigned programs., • Define clinical priorities and oversee the development of protocols, amendments, and integrated development plans tailored to obesity and metabolic indications., • Ensure delivery of high-quality clinical study outputs on time and within budget., • Act as the primary medical point of contact for regulatory agencies for assigned programs., • Partner closely with Regulatory Affairs, Clinical Operations, Program Management, CMC, and other functions to ensure alignment and execution., • Lead preparation, review, and contribution to key regulatory documents, including IND submissions, investigator brochures, clinical study reports, and regulatory briefing packages., • Participate in and support FDA/EMA meetings and regulatory interactions related to obesity and metabolic disease development., • Establish and maintain strong working relationships across clinical operations, regulatory, biostatistics, translational science, safety, and commercial teams., • Build and maintain relationships with key external stakeholders, including key opinion leaders in obesity and metabolic disease, investigators, consultants, and patient advocacy organizations. Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis. On-Site Protocol: Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. Qualifications: • Medical Degree (MD)., • Minimum 8+ years’ experience in leading clinical studies within the biotech/pharmaceutical industry., • Experience leading studies for obesity or metabolic disease in the pharma industry, • Minimum 5 years of leadership experience with excellent line management skills., • Highly developed ethics and integrity, with demonstrated ethical medical decision-making skills., • A proven track-record of leading clinical trials at all stages., • Expertise in the areas of drug development, clinical operations and strategic planning., • Expertise in scientific and clinical data review and interpretation, including in-depth analysis and presentation of data from strategic perspectives, • Expertise with SOPs, GCP, ICH guidelines, regulatory compliance requirements, and risk mitigation strategies., • Experience with FDA/EMA processes (IND filing, NDA filings)., • Board certification in Endocrinology, Diabetes, Metabolism or similar discipline, • Experience in operations management within a clinical research setting., • Strong leadership skills with the ability to work in a dynamic, fast-paced environment., • Strong understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders., • Attention to detail while discriminating between critical and non-critical activities and to follow established processes., • Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively in a dynamic and collaborative, fast-paced environment., • Strong problem-solving skills and a proactive attitude towards exploring new approaches., • This is a full-time position, Monday-Friday, occasionally overtime., • Pay is commensurate with experience., • Equity-based compensation, • Performance-based bonuses, • 401(k) with Company Match, • Medical, Dental, Vision, • Flexible Spending Account, • Life Insurance, • Employee Assistance Program, • Employee Discounts, • Gym Membership, • Paid Vacation, • Paid Holidays, • United States (Required), • Background Check, • As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check. Company Overview: ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx has developed proprietary RNA targeting platforms and technology for silencing or editing target mRNA. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system. ADARx currently has multiple active programs in development with the lead candidate in the clinic. We are well-financed by a syndicate of renowned VC firms. ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Disclosure Statement: • The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position., • Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations., • The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law., • Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses., • Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information.

Job DescriptionDescription: The Clinical Trials Manager (CTM) will support the conduct of clinical trials and data collection and review, monitoring adherence to protocols, and all activities related to trial completion. The CTM ensures timely conduct of clinical trials according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials. The CTM will interact internally and externally with members of cross functional trial team, and, externally with service providers, investigational site personnel, and others involved in the conduct of the business. The scope of this position requires excellent organizational, communication, and presentation skills, with strong experience in executing all phases of clinical trials. The position requires one to be on-site daily in the San Diego office and remote work is not an option. Essential Duties and Responsibilities The main responsibilities of this role include but are not limited to the following: • Manages trial operational plan and CRO activities, including project timelines & quality of deliverables, and managing approved trial budget(s) throughout the life of the assigned clinical trial(s)., • Supports all aspects of clinical trial management and processes from initiation, planning, execution, maintenance and close-out., • Ensure enrollment and data collection are completed in accordance with trial timelines and objectives; escalates risk to timelines and budget as needed., • Identifies and provides solutions to clinical trial issues and/or risks., • Proactively identifies project risks and resolves with some supervision., • Represents Clinical Operations in cross-functional initiatives, as assigned by management, and may act on behalf of team when designated., • Serve as a liaison and resource for investigational sites., • Assists with preparation of RFP's and bid templates to facilitate selection of the CRO's/vendors., • CRO Selection: Assist with review of proposals from CROs, review CROs’ SOPs, prepare and recommend CRO to management., • Participates in the selection of trial vendors for assigned trials., • Maintains frequent and meaningful contact with CROs to assess performance and provide guidance as needed., • Oversee clinical trial sites' adherence to pertinent regulations through review of monitoring reports, CQA-GCP audit report, communications with investigators, trial site personnel, CRAs, and other CRO/designee personnel., • Coordinate the design, format and content of CRFs, trial guides, trial reference binders, patient diaries, and forms including participating in the EDC and specification process and UAT., • Contributes to relevant trial documentation including clinical protocols, statistical analysis plan, clinical trial reports as well as operational plans (CMP, DMP)., • Reviews and refines clinical operational plans including the trial monitoring plan and other study plans as needed., • Coordinates internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical trials., • Participates in the selection of investigational sites with input from Clinical Research and vendors., • Identify potential trial issues and recommend and implement solutions or corrective actions as needed., • Participate in Site Initiation Visits and Co-monitoring Visits for adherence to protocol and GCP as required., • Performs other duties as required. Requirements: Education and Experience • Bachelor’s Degree Must have a demonstrated track record of managing clinical trials from Phase 1 to Phase 3 Strong knowledge of FDA, ICH, GCP, CFR guidelines, regulatory requirements and clinical trial operations. Demonstrated knowledge and a clear understanding of the overall drug development process, including experience with most phases of the clinical research process, including but not limited to: • Site selection, • Trial initiation procedures, • Clinical monitoring functions, • Data flow from sites to data processing, review, and resolution, • Drug safety and regulatory affairs issues, • Ability to exercise judgement within broadly defined practices and processes, • Experience negotiating vendor/site contracts and managing the budgets, • Solid vendor management skills, e.g. CRO, Laboratory, Clinical supply logistics, • Developing and maintaining standard operating procedures and processes., • Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential and to ability to develop budgets and manage contracts., • Ability to edit technical documents, informed consent, and other trial-related documents., • Proficiency with computer programs including Microsoft Office suite and Microsoft Project., • Conduct training to ensure personnel are knowledgeable and familiar with internal process and job functions/duties. Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Notice to Agency and Search Firm Representatives Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

Job DescriptionThe Clinical Trial Manager/Sr. CTM will play a pivotal role in the strategic implementation and execution of clinical trials from study start-up to close-out. This individual will be instrumental in managing and overseeing CROs, study vendors, and clinical trial sites, while partnering with key internal stakeholders to ensure clinical trial deliverables are completed on time, within budget, and in accordance with regulatory requirements, GCP guidelines, and internal SOPs. This position reports directly to the Director of Clinical Operations and serves as an integral member of the Clinical Operations team, contributing to the development of trial strategy, executing initiatives, and ensuring the highest standards in operational delivery. This is a great opportunity to make a meaningful impact in a fast-paced, mission-driven biotech environment.ESSENTIAL FUNCTIONS AND RESPONSIBILITIES • Lead the successful execution of clinical trials from protocol concept to clinical study reports in support of complex oncology programs., • Ensure inspection readiness by maintaining comprehensive study documentation and files., • Organize and lead study and departmental meetings, including minute-taking and document archiving., • Coordinate clinical trial equipment, supplies, and cross-functional project activities (e.g., Clinical Data Review Meetings)., • Ensure team compliance with study-specific training and perform TMF reviews for completeness., • Support clinical sites in audit and inspection preparation., • Assist with budget management and daily clinical operations, ensuring adherence to SOPs, ICH/GCP, and regulatory requirements., • Monitor subject and site activity/metrics and perform quality checks across study components., • Proactively identify, troubleshoot, and escalate issues impacting deliverables., • Contribute to study set-up activities including protocol/synopsis development, informed consent forms, system configuration (CTMS, IRT), regulatory submissions, and operational documentation., • Collaborate with CROs to ensure timely collection and archiving of TMF documents., • Partner with regulatory affairs on essential document submissions., • Support study close-out activities including TMF and drug reconciliation and CSR readiness., • Foster effective communication and collaboration with study team members, Clinical Trial Managers, and Asset Leads., • Participate in process improvement and quality initiatives related to study execution., • Other duties as deemed necessary.REQUIRED EDUCATION, EXPERIENCE, SKILLS, AND ABILITIES, • Bachelor’s degree with at least 5 years of hands-on clinical trial experience, within a pharmaceutical or biotech environment. A combination of CRO and sponsor-side experience will be considered., • Demonstrated experience in oncology trials, including trial set-up, monitoring, and close-out., • Global clinical trial management experience, especially in the EU, highly desirable., • Strong working knowledge of ICH/GCP regulations., • Proficiency with electronic systems such as eTMF, CTMS, EDC, etc., • Ability to work independently and thrive in a collaborative team environment., • Strong critical thinking skills, a sense of urgency, and a proactive problem-solving mindset., • Excellent interpersonal, written, and verbal communication skills., • Proficiency in MS Office and comfort with technology.

Job Description We are partnering with a client on the search for a Head of Biometrics to join their leadership team. Reporting to the Chief Medical Officer (CMO), the Head of Biometrics will provide leadership for driving the company's Biometrics activities for all studies across the world, including management of biostatistics, programming, medical writing, and data management. This leader will shape and influence the entire portfolio and will be responsible for creating vision, leading, developing, and implementing statistical solutions to optimally support all phases of clinical trial and project decision making. The ideal candidate will have proven leadership and communication skills with a drive for delivering innovative bioinformatics-based analysis solutions across a broad range of use cases. This role requires someone with a track record of establishing a strategic roadmap for innovations across bioinformatic methods and algorithms, delivering continuous improvements in core analysis capabilities, establishing an information delivering system, and effectively working with stakeholders. Key Job Responsibilities * Provide leadership and vision for the Biometrics team; responsible for setting, designing, and developing the vision and goals for Biostatistics, Statistical Programming, Data Management, and Medical Writing. Translate strategies and tactical plans into practical and effective actions. * Manage the development of SOPs, statistical programs, and deliverables by CROs for biostatistics, statistical programming, and data management. Collaborate with other functions to ensure data collection and reporting is done in conformance with ongoing practices and regulatory expectations. * Deliver statistically sound scientific methodology experimental design and data analysis input to meet project objectives for global regulatory organizations such as FDA and EMA. Adheres to regulatory guidelines for statistical and clinical data analysis, data structure, and new developments in statistics and drug development. * Author statistical analysis sections of protocols, statistical analysis plans, clinical study reports, regulatory documents, and scientific publications; generates or reviews study randomization and sample size/power estimations. * Liaison for all statistical and operational aspects pertaining to Data Monitoring Committees. * Reports study results of appropriate statistical analyses, in collaboration with clinical development, to provide appropriate interpretation of data and sound study conclusions. * Becomes familiar with the disease states and therapeutic space to enhance the level of collaboration and be able to evaluate implications of study designs. Leadership Attributes * Able to thrive in a fast-paced, dynamic small company environment with ability to adjust workload based upon changing priorities. * Critical thinker with a demonstrated ability to collaborate with both leadership and teams, demonstrating ability to influence, make sound decisions, and drive alignment. * Natural leader with a positive management style, combined with superior communication skills and unwavering ethics and integrity. * Proven interpersonal skills and executive presence, with an effective ability to quickly establish credibility, trust, and support within all levels of the organization. * Leads and reinforces company values and culture in day-to-day behaviors, management style, and expectations. * Self-starter, able to drive work forward within an agile environment with a track record of executing against results. Requirements * A minimum of 15 years of progressive, relevant leadership experience in pharmaceutical or biotechnology clinical trials. Must have early development experience while full-cycle drug development/pharmaceutical experience is highly preferred. * An advanced degree MS or PhD in Statistics, or Biostatistics, or a related field. * Technical knowledge of database structure, and relevant statistical software (e.g., SAS®, East®, and R. programming) background preferable. * Experience with statistical and operational aspects pertaining to Data Monitoring Committees. * Demonstrated agility to learn, and prioritize multiple responsibilities independently, remove barriers and drive projects to completion. * Able to understand and communicate scientific data effectively at all levels and present complex and/or new ideas with clarity and simplicity. Experienced presentation skills tailored to engage and communicate with diverse audiences (investigator meetings, site personnel, KOL interactions and internal project teams).

Job Description Primary Responsibilities Senior Clinical Trial Manager is responsible for ensuring the quality of clinical trials and implementing and overseeing various projects. Senior Clinical Trial Manager collaborates with the designated CRO and vendors, as well as internal team across functions, and directs activities to execute and deliver the assigned studies. This role reports to the Director of Clinical Operations. Specific Duties, may include but not be limited to the following: • Acting as a primary liaison with the CRO/CROs on the assigned projects, including global multi-center trials., • Providing management and oversight for the CROs/vendors involved in the assigned projects ensuring on time and on budget delivery., • Partnering with other functions internally to achieve key milestones, optimize processes and achieve efficiencies., • Providing regular reporting on project metrics and serving as internal liaison at Immuneering, regarding all project related inquiries, presentations and updates, • Creating and implementing study-specific clinical monitoring tools and documents in collaboration with CRO/vendors and internal team., • Identifying and choosing/approving sites and coordinating site startup activities., • Supervising and having regular meetings with the CRO and other clinical vendors involved in the projects, • Reviewing the clinical trial agreements and budgets for the CRO, vendors and clinical sites, • Overseeing the CRO’s contact with the study sites, including ordering/providing supplies and investigational product, and site management., • Ensuring inspection readiness and that all study activities are conducted in compliance with the protocol and procedures, GCP, FDA/EMA/local regulations, guidelines and policies., • Escalating issues as needed to the Sr Director, Clinical Operations with the proposed action plan, • Participating in the development of SOPs, working guidelines, mentoring and educational activities EDUCATION • B.S. (or higher) degree in a Science or related field required, • Minimum 8 years of work experience for a pharmaceutical company or CRO, • Minimum of 8 years of work experience in PM/CTM (or equivalent) roles on Oncology projects, • Global multi-center trial experience is required, • Demonstrated application and working knowledge of global GxP regulations for pharmaceutical industry (i.e., Good Clinical Practices, Good Lab Practices, current Good Manufacturing Practices, 21 CFR Part 11 Electronic Records; Electronic Signatures, MHRA/EMA/FDA regulatory body inspections) TECHNICAL / SOFT SKILLS • Outstanding communication skills, both verbal and written, • Proficient with Microsoft Office Word, Excel, PowerPoint, MS Project, • Ability to work independently and prioritize duties, • Understanding of Electronic Data Capture (EDC) and other clinical systems, • Strong analytical and organization skills, • Self-motivated and self-directed Physical Demands/ Working Conditions The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires the ability to perform essential job functions with or without reasonable accommodation. No significant lifting is associated with the role. While extensive travel is not anticipated with this role, it is possible to perhaps up to 10% at times. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role. Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission. Job Offers: Immuneering uses the Immuneering.com domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam. Note to Recruitment Agencies: We appreciate your interest in finding talent for Immuneering but please be advised that we do not accept unsolicited resumes from recruitment agencies. All resumes submitted to Immuneering without a prior written agreement in place will be considered property of Immuneering, and no fee will be paid in the event of a hire. Thank you for your understanding.

Job Description Company Overview: Contineum Therapeutics (Nasdaq: CTNM) is a clinical-stage biopharmaceutical company pioneering novel, oral small molecule therapies for NI&I indications with significant unmet need. Contineum is advancing a pipeline of internally-developed programs with multiple drug candidates now in clinical trials. PIPE-791 is an LPA1 receptor antagonist in clinical development for idiopathic pulmonary fibrosis and chronic pain. PIPE-307 is a selective inhibitor of the M1 receptor in clinical development for relapsing-remitting multiple sclerosis and major depressive disorder. For more information, please visit . Job Summary: The in vivo biology group at Contineum Therapeutics is currently seeking an energetic Sr. Scientist to join our drug discovery team in San Diego. This is a hands-on, laboratory position with responsibilities involving focused conceptualization and execution of in vivo studies to evaluate drug candidates. Studies may encompass a range of neuroscience, immunology, and inflammatory (NI&I) conditions, including but not limited to neurodegeneration, peripheral neuropathies, and fibrosis. The successful candidate will have expertise in all aspects of in vivo pharmacology and biology and be a strong team player who is scientifically curious, enjoys the process of scientific discovery, and can communicate well in an interdisciplinary environment. This role is office-based in San Diego, CA and relocation is not provided. Key Responsibilities: • Design, conduct, and manage experiments related to the discovery of novel candidates, • Design and conduct PK/PD experiments, • Conduct mechanistic studies related to biological targets of interest both independently and in collaboration with other scientists, • Create and establish novel and pharmaceutical industry-standard in vivo models of conditions related to NI&I, • Ph.D. in Biology, Neuroscience, Physiology, Pharmacology, or related discipline required, • 1-3 years industry experience or equivalent, • Expertise in conducting basic in vivo procedures, including drug administration, blood collection, animal handling, and care. Advanced procedures, e.g., survival surgeries, helpful., • Experience with data management and presentation, experimental design, and data analysis methods, • Ability to work independently and in a matrixed team environment and flexible in adapting to change, • Strong verbal and written communication skills We offer a competitive total compensation package, as well as working in a supportive team environment. The anticipated salary range for candidates is $138,000- $145,000. 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 within the job, type and length of experience within the industry, education, etc. Contineum offers competitive compensation and benefits, including: • 90% employer-covered benefits, • Flexible PTO, • A very generous holiday schedule that includes a week off in August and time off around the winter holidays, • A well-stocked kitchen with snacks and beverages, • Additional benefits include the opportunity for annual bonuses, stock options, an Employee Stock Purchase Program, and a 401(k) with an employer match., • The comprehensive wellness program includes medical, dental, vision, and LTD coverage.

Job Description Position Summary: The Director, Clinical Pharmacology, plays a pivotal role in leading clinical pharmacology activities to support drug development programs. The incumbent will apply model-informed drug development (MIDD) approaches to optimize the benefit-risk profile of oncologic drugs, while increasing the probability of success and efficiency of drug development programs. This position also involves designing and executing clinical pharmacology aspect of clinical studies, conducting and interpreting pharmacokinetic (PK), PK/pharmacodynamic (PD) and exposure(E)/response (R) analyses, collaborating with interdisciplinary teams, and contributing to regulatory filings and interactions. This is an onsite position in San Diego. Key Responsibilities: • Act as clinical pharmacology lead in study teams and provide clinical pharmacology expertise to study design, data analysis and interpretation, and overseeing clinical pharmacology studies by working with CROs., • Responsible for conducting non-compartmental analysis of human clinical PK data, and PK and PK/PD analyses including population PK, PK/PD and Exposure/response modeling and simulation, and meta-analysis., • Provide the clinical pharmacology components of Clinical Development Plans, IBs, and regulatory documents such as INDs, Briefing documents, responses to regulatory queries, etc., • Design, author and/or review clinical (pharmacology) study protocols, including PK/PD, drug-drug interaction (DDI), bioavailability, and first-in-human studies, and support the execution of clinical trials when applicable, conduct pharmacometrics analyses, and incorporate findings into study report and regulatory documents as well as participate directly in regulatory interactions., • Provide Clinical Pharmacology expertise to discovery team during the pre-clinical stages of drug development and works with research colleagues to ensure quantitative mechanistic understanding of preclinical PK-PD data to inform human administration., • Ph.D. or PharmD or equivalent in life sciences, pharmaceutical sciences or related field., • 5 to 10 years of related experience., • Strong hands-on experience with pharmacometrics software (e.g., NONMEM, Monolix, Phoenix WinNonlin, R)., • Understanding of drug development in oncology or other therapeutic areas., • Excellent analytical and problem-solving skills, with the ability to interpret complex data and translate findings into actionable drug development strategies., • Excellent interpersonal, leadership, communication and time-management skills are essential. AAP/EEO Statement: The company provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Recruiters and Agencies: BlossomHill Therapeutics does not accept unsolicited referrals or resumes from any source other than directly from candidates. We will not consider unsolicited referrals and/or resumes from vendors including and without limitation, search firms, staffing agencies, fee-based referral services and recruiting agencies. The submission of referrals or resumes by anyone other than a candidate directly to BlossomHills’ employees is strictly prohibited. Unsolicited referrals and resumes sent to BlossomHill Therapeutics are deemed gratuitous, and the company will not be obligated or bound in any way to pay any referral or other fee if a person referred to us from a source other than a candidate is hired.

Job DescriptionSalary: About Artiva: Artiva is clinical-stage, publicly-traded biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers. Artivas lead program, AlloNK, is an allogeneic, off-the-shelf, non-genetically modified NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. AlloNK is delivered in the outpatient setting with no required hospitalization. AlloNK is currently being evaluated in three ongoing clinical trials for the treatment of B-cell driven autoimmune diseases. This includes two company-sponsored trials, one in systemic lupus erythematosus for patients with or without lupus nephritis, and a basket trial across autoimmune diseases (Rheumatoid Arthritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathies and Sjgrens Disease), as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases. Artivas pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers. Artiva was founded in 2019 as a spin out of GC Cell, formerly GC Lab Cell Corporation, a leading healthcare company in the Republic of Korea, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia and New Zealand) to GC Cells NK cell manufacturing technology and programs. Artiva is headquartered in San Diego, California. For more information, visit. Job Summary: The Senior Director, Safety and Pharmacovigilance (PV) is responsible for leading, building, and managing Safety and PV activities across all clinical programs at Artiva, ensuring compliance with global regulatory requirements and internal standards. Essential Duties and Responsibilities: • Oversee global Safety and PV activities to ensure compliance with applicable regulatory requirements and guidances., • Oversee adverse event case processing (ICSRs) and aggregate reporting (DSUR) to ensure high-quality safety reports are submitted within required timelines to regulatory agencies and external stakeholders., • Lead the preparation and review of safety-related sections for clinical and regulatory documents., • Partner with Clinical Leads and Medical Monitors for medical review and reporting of individual adverse events and reactions, ensuring appropriate assessment of case seriousness, causality, expectedness, medical coding, and case follow-ups., • Serve as the primary liaison with internal departments and external partners on Safety and PV related issues., • Develop and update drug safety forms and templates, ensuring harmonization with clinical operation functions during study start-up and conduct of clinical studies., • Manage Safety and PV vendor relationships, execution of responsibilities, and ensuring compliance with safety data processing and submission activities., • Ensure effective serious adverse event (SAE) reconciliation between clinical and safety databases., • Develop and implement Safety and PV process improvements, tools, systems, and procedures., • Provide input into responses to regulatory inquiries and safety issues., • Contribute to the development and updates of safety documents, including core data sheets, investigator brochures, labels, and RMPs as required., • Participate in regulatory inspections and internal audits and author responses to findings., • Maintain close interactions and oversee the assessment and performance of assigned personnel, fostering an environment of professional development., • Able to work cross-functionally with other development and functional areas in the organization. Requirements: • Minimum of 5 years of Drug Safety and PV experience in a biopharma or biotech organization., • A health care professional background (e.g., MD, RN, BSN, PharmD, Physician Assistant) is required., • Strong understanding of global Safety and PV regulations, including EU and US regulations and ICH guidelines., • Excellent understanding of Good Pharmacovigilance Practices, GCP, clinical trial methodology, and medical terminology., • Proficiency with safety databases (e.g. Argus), regulatory regulations, and MedDRA coding., • Excellent interpersonal, organizational, and communication skills., • Strong project management and problem-solving abilities., • Attention to detail and quality-focused approach., • Proven ability to prioritize workload and meet deadlines., • Demonstrated initiative and flexibility through effective, innovative leadership., • Strong negotiation and communication skills, with the ability to operate in a global, culturally diverse environment, • Ability to work effectively both independently and in a team setting., • Willingness to travel as required. Why you should apply: We have a fantastic team and philosophy! We are passionate We deeply care about our team, our science, and improving the lives of autoimmune and cancer patients. We are tenacious we are laser-focused on our mission and undeterred in our commitment to make cell therapies broadly accessible to patients with autoimmune disease and cancer. We are innovative - pushing into new frontiers for patient benefit.We are transparent - believers in flat, accessible, and open communication paths.We are inclusive committed to the diversity of our team and ensuring that all voices are heard. In addition to a great culture, we offer: A beautiful facility An entrepreneurial, highly collaborative, and innovative environment Comprehensive benefits, including: • Medical, Dental, and Vision, • Group Life Insurance, • Long Term Disability (LTD), • 401(k) Retirement Plan, • Employee Assistance Program (EAP), • Flexible Spending Account (FSA), • Paid Time Off (PTO), • Company paid holidays, including the year-end holiday week, • Our recognition program, Bonus.ly, is where you can trade in points earned for things you want. If all this speaks to you, come join us on our journey! Base Salary: $265,000 - $280,000. Exact compensation may vary based on skills and experience.

Job Description Director, Quality Systems & Compliance (Remote) About Immuneering Immuneering (Nasdaq: IMRX) is a clinical-stage oncology company developing medicines for broad populations of cancer patients. Our initial aim is to develop a universal-RAS therapy, an approach designed to include patients with solid tumors driven by any mutation in KRAS, NRAS, or HRAS. Our inclusive approach differentiates us from narrowly targeted precision therapies, which are limited to patients with tumors harboring select mutations. We are currently evaluating our lead product candidate, IMM-1-104, in a Phase 2/3 a clinical trial in patients with advanced solid tumors harboring RAS mutations. IMM-1-104 is being developed as a once-daily oral monotherapy that aims to achieve universal-RAS activity through deep cyclic inhibition of the MAPK pathway. Deep cyclic inhibition is a novel mechanism that aims to deprive tumor cells of the sustained proliferative signaling required for rapid growth, while sparing healthy cells through a cadenced, normalized level of signaling. This mechanism was engineered using our proprietary informatics-based discovery platform. Immuneering’s R&D team is based in a ~38,000 square foot lab and office facility in San Diego. The company also has offices in New York City and Cambridge, MA. Immuneering has grown to approximately 55+ employees, all working to apply their expertise, passion and creativity to improve the lives of people with serious diseases. Immuneering’s team works collaboratively and relentlessly, thinking across traditional boundaries to help shape the frontiers of drug development. General Summary of Duties: Be an integral part of Immuneering by spearheading, growing and developing robust quality processes and procedures. Join a diverse and collaborative group and make a deep impact of moving science forward in a fun, hybrid work environment which celebrates innovative thinking and where your input will be respected and sought out as an expert in your field. This role can be remotely based with the ability to travel to our offices and meetings as needed. The Director of Quality Systems & Compliance will be responsible for developing, implementing, and maintaining robust GxP-compliant quality systems to support Immuneering’s major initiatives related to our drug discovery, clinical trials, filings, and ultimately to commercialization. A successful candidate will be a highly collaborative individual with strong interpersonal skills and will be an exceptional team player who embraces our mission, vision, and values. Specific Duties may include but not be limited to the following: • Serve as business owner for document and learning management systems which are maintained in an electronic quality management system (eQMS) for GxP activities., • Contribute to the development, implementation, and lifecycle management of GxP documents and training programs to ensure processes, systems, and content meet phase appropriate quality standards and business goals (e.g., Phase 3 requirements)., • Author and maintain site policies, standard operating procedures (SOPs) for document control, training, quality events, Corrective and Preventive action (CAPA), change control, and risk management to support GxP compliance activities., • Ensure appropriate training requirements are defined in GxP job-specific roles and curriculum for company-wide matrix. Manage requirement updates, as applicable., • Administer learning management system via eQMS, curriculum creation, scheduling, reporting, and facilitate technical support guidance., • Ensure data integrity and compliance within all GxP electronic systems., • Partner with IT to ensure system upgrades, management, and business changes to eQMS are conducted in accordance with internal SOPs and external requirements., • Ensure compliance with legal and regulatory standards for document archival/retention., • Monitor and continuously improve system performance and inspection readiness, using metrics and analytics to proactively address risks, strengthen compliance, and enhance user experience., • Facilitate or support inspections by regulatory authorities and maintain a state of inspection readiness., • Participate in internal and external audits as needed., • Provide QA support for deviations, CAPAs, effectiveness checks, change controls, investigations (OOS/OOT), and risk assessments., • Lead investigation/CAPA triage meetings and collaborate with cross- functional groups to ensure timely resolution and metric compliance., • Support Quality Management Review Program by tracking and trending data for system performance and improvements., • Generate reports and dashboards to monitor GxP activity performance, compliance, and training effectiveness., • Act as a trusted advisor to internal teams, providing compliance guidance and facilitating timely resolution of quality issues., • Develop and maintain effective working relationships with stakeholder functions to achieve GxP compliance goals., • Exceptional attention to detail required., • Must be flexible and agile with the ability to pivot, to prioritize business needs. Desired Skills and Qualifications • Minimum of a Bachelor’s degree in preferably life science (technology, biological science, pharmacy, nursing, or other health related discipline preferred) or equivalent qualification., • 8+ years’ experience in Quality and has supported pharmaceutical development from early phase transitioning into a commercial stage environment., • The ability to establish congenial and productive working relationships., • Exceptional communication skills, both written and verbal, QA writing skills are paramount., • Capability to manage multiple workflows within a single day., • Ability to effectively work within cross-disciplinary teams., • Must be a self-starter, proactive, motivated, ambitious, scientifically curious, and collaborative with a humble demeanor. Physical Demands/ Working Conditions The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role. While extensive travel is not anticipated with this role, it is possible to perhaps up to 10% at times. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role. Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission. Job Offers: Immuneering uses the Immuneering.com domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam. Note to Recruitment Agencies: We appreciate your interest in finding talent for Immuneering but please be advised that we do not accept unsolicited resumes from recruitment agencies. All resumes submitted to Immuneering without a prior written agreement in place will be considered property of Immuneering, and no fee will be paid in the event of a hire. Thank you for your understanding.

Job Description Location: This role is onsite at CPMI in Miami, FL If you are not local to Miami, let's discuss how to get you there! This is a newly created role at an amazing, top clinical research site located in Miami, FL About Company: Who is ERG? ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with an expertise in early and late-stage neuroscience drug development. With 19 wholly owned clinical sites and 5 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 340+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 + completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally. About the Role: We are seeking a highly qualified Manager/Director of Clinical Operations, Phase I, to oversee clinical trials, ensuring protocol adherence, and managing both staff and operational aspects of studies. This role demands strict compliance with GCP, ICH guidelines, and company SOPs. Core duties include staff management, protocol review, quality assurance, and overall study supervision. Responsibilities: • Lead and mentor the clinical operations team to promote a collaborative and efficient environment., • Ensure protocol compliance and maintain high-quality standards across studies., • Collaborate closely with Principal Investigators and Site Directors to assign studies and develop enrollment strategies., • Oversee human resources functions, including staff evaluations, recruitment, and training., • Monitor adherence to protocols, reporting any deviations to sponsors and regulatory bodies., • Coordinate with Site Director and Principal Investigator to assign primary clinical research coordinators., • Review study components with Principal Investigators and Site Directors, identifying areas requiring clarification before study initiation., • Conduct study closeout procedures., • Perform additional duties as needed to adapt to the evolving needs of CPMI., • Bachelor's degree in a scientific or healthcare-related field, • 7-10 years of experience in clinical operations, including 5+ years in a senior leadership role., • Strong understanding of FDA, ICH, and GCP regulations and guidelines, • Strong communication, organizational, and leadership skills., • Ability to travel as needed and proficiency in Microsoft Word, Excel, and clinical management software., • In-depth knowledge of clinical trial operations, including study start-up, site selection, patient recruitment, monitoring, data management, and study close-out, • Phase I or early phase experience Our comprehensive benefits package includes: • Health insurance, • Dental & Vision Insurance, • Matching 401k Retirement Plan, • Paid Time Off (PTO)

Job Description Job Description: We are seeking a highly motivated and qualified individual to join our CMC Department as a Clinical Supply Chain Specialist and work as part of a team to drive success. The Clinical Supply Chain Specialist, Clinical Supplies will support the planning, coordination, and execution of global clinical supply activities for company-sponsored clinical trials. This role will partner cross-functionally with Clinical Operations, CMC, Quality, Regulatory, and external vendors to ensure uninterrupted supply of investigational product (IP) to clinical sites while maintaining compliance with GxP, regulatory, and company requirements. The ideal candidate is detail-oriented, highly organized, and experienced in managing clinical supply logistics in a fast-paced pharmaceutical or biotech environment. Essential Responsibilities: • Develop and promote a workplace culture that values diversity of thought, promote integrity and create an atmosphere that supports coaching and fosters accountability., • Carry out assigned laboratory functions applying knowledge and skill in an accurate, timely manner., • Establish and maintain excellent working relationships with critical collaborative partners throughout the company., • Support end-to-end clinical supply chain activities including forecasting, planning, packaging, labeling, distribution, returns, and reconciliation of investigational product., • Coordinate with internal stakeholders and external CMOs, depots, and logistics vendors to ensure timely manufacturing and delivery of clinical supplies., • Maintain and track inventory levels at depots and sites; proactively identify and mitigate potential supply risks., • Generate and manage clinical supply forecasts and resupply strategies based on enrollment projections, drug product expiry dates, and study timelines., • Support creation and review of packaging and labeling specifications in alignment with study protocols and regulatory requirements., • Manage Interactive Response Technology (IRT/RTSM) supply settings and ongoing updates in collaboration with Clinical Operations and vendors., • Prepare and review shipment documentation and ensure compliance with import/export and country-specific requirements., • Reconcile clinical supplies, including returns, destructions, and accountability documentation., • Contribute to development and continuous improvement of SOPs, work instructions, and supply chain processes., • Ensure all activities comply with GCP, GMP, and applicable regulatory guidelines., • Maintain accurate documentation and support audits and inspections as needed., • Provide Operational support services to CMC development and manufacturing functions., • Reviews and recommend updates for departmental SOPs, may draft updates to SOPs depending on experience and level., • Maintain all appropriate corporate standards for facility safety and hazardous material management. Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis. On-Site Protocol: Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. Qualifications: • Bachelor’s degree in supply chain, life sciences, or related field., • BS with 3+ years of experience or MS with 1.5 years of experience in clinical supply chain, clinical operations, or pharmaceutical logistics., • Excellent organizational, written and verbal communication skills; and effective presentation of complex scientific data to cross-functional and senior management teams are essential for this role., • Working knowledge of GxP requirements and global clinical trial supply practices., • Knowledge of clinical trial material and/or investigational drug product, • Experience coordinating with CMOs, depots, and third-party logistics providers., • Familiarity with IRT/RTSM systems and clinical supply management tools., • Strong organizational skills with the ability to manage multiple studies and priorities simultaneously., • Experience supporting global, multi-site clinical trials (Phase I–III)., • Understanding of temperature-controlled shipping and cold chain management., • Experience with import/export documentation and international shipping regulations., • Must be able to work independently with supervision as needed., • Proficient at working independently as well as in cross-functional team settings, • Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism., • Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively in a dynamic and collaborative, fast-paced environment., • Strong problem-solving skills and a proactive attitude towards exploring new approaches., • This is a full-time position, Monday-Friday., • Pay is commensurate with experience., • Equity-based compensation, • Performance-based bonuses, • 401(k) with Company Match, • Medical, Dental, Vision, • Flexible Spending Account, • Life Insurance, • Employee Assistance Program, • Employee Discounts, • Gym Membership, • Paid Vacation, • Paid Holidays, • United States (Required), • Background Check, • As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check. Company Overview: ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a clinical stage biotechnology company dedicated to transforming cutting-edge science into next-generation RNA therapeutics to treat a broad spectrum of diseases. Our goal is to control the expression of specific disease drivers with highly selective RNA targeted therapies, delivering life-changing treatments for patients with urgent unmet medical needs. ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Disclosure Statement: • The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position., • Data: Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations., • Recruiters & Staff Agencies: ADARx Pharmaceuticals (ADARx) does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to ADARx or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of ADARx and the Company will not owe any referral or other fees with respect thereto., • Compensation: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law., • Total Compensation: Includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses., • Conditional Offer of Employment: Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.

Job Description (Associate) Director, Clinical Scientist (Remote) Key Responsibilities • Provide scientific and strategic leadership in the planning and execution of clinical trials, including protocol development, study design, and data analysis., • Author and review clinical protocols, ICFs, CSRs and regulatory documents, • Collaborate closely with cross-functional teams, including Clinical Operations, Regulatory Affairs, Biostatistics, and Medical Affairs, to ensure the successful conduct of clinical studies., • Interpret clinical data, prepare study reports, and contribute to regulatory submissions and presentations for internal and external stakeholders., • Support investigator meetings, advisory boards and data monitoring committee meetings, • Stay current with emerging scientific literature, competitive landscape, and regulatory requirements relevant to Immuneering’s oncology therapeutic area., • Support the development of clinical development plans and contribute to the strategic direction of ongoing and future programs., • Work closely with CRO’s and have a can do, proactive biotech mindset. Qualifications & Education · PhD, PharmD, RN, or MD in a relevant scientific discipline (e.g., biology, pharmacology, medicine). · Minimum of 5-8 years of experience in clinical development within the pharmaceutical or biotechnology industry. · Direct Phase 3 oncology clinical trial experience required. · Demonstrate experience authoring and reviewing clinical documents. · Demonstrated strong experience in clinical trial execution and data interpretation. · Strong analytical, organizational, and communication skills. · Deep understanding of oncology clinical development, endpoints and regulatory expectations. Technical / Soft Skills · Excellent cross-functional communication and stakeholder management. · Ability to work collaboratively in a fast-paced, team-oriented environment. · Must be a strong champion of our Values: All in, Data Rules, Care, Humble, Own It (Accountable) Physical Demands/ Working Conditions The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires the ability to perform essential job functions with or without reasonable accommodation. No significant lifting is associated with the role. While extensive travel is not anticipated with this role, it is possible to perhaps up to 15% at times. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role. Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission. Job Offers: Immuneering uses the Immuneering.com domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam. Note to Recruitment Agencies: We appreciate your interest in finding talent for Immuneering but please be advised that we do not accept unsolicited resumes from recruitment agencies. All resumes submitted to Immuneering without a prior written agreement in place will be considered property of Immuneering, and no fee will be paid in the event of a hire. Thank you for your understanding.

Job Description MPF Federal seeks a Quality Assurance Supervisor to support the Naval Health Research Center (NHRC), Operational Infectious Diseases (OID) Directorate. Reporting to the Contract Program Manager and under the mentorship of the Sr. Laboratory Manager, this role oversees the Quality Management System, ensures compliance to regulatory standards, and makes continuous improvements. The NHRC OID is seeking a meticulous and proactive Quality Assurance Supervisor to manage and maintain the integrity of critical research regulatory compliance and documentation. This vital role is responsible for ensuring the accurate and secure storage, retrieval, and control of all laboratory records, SOPs, batch records, and other essential documentation related to operational infectious disease research. The Quality Assurance Supervisor will play a key role in supporting quality assurance efforts, maintaining regulatory compliance, and facilitating efficient data management practices. This position requires a strong understanding of quality systems, exceptional attention to detail, and the ability to collaborate effectively with cross-functional teams to ensure the highest standards of data quality and regulatory adherence. The OID Directorate conducts biosurveillance, clinical trials, research, and diagnostic testing to protect our warfighters, their families, and the homeland against infectious diseases and promote global health security. OID maintains a CLIP (Clinical Laboratory Improvement Program) and CAP (College of American Pathologists) accredited laboratory to support all categories of testing. Test specimens are collected and tested in accordance with their respective study protocols, and results are provided to the applicable sponsors, the Armed Forces Health Surveillance Center, local investigators and collaborators, ordering physicians, and county health units to guide proper responses that ultimately affect both the readiness of US forces and the safety of public health. COMPENSATION: $92,000 - $100,000 annually Responsibilities · Develops and maintains the Quality Management System (QMS), including the eQMS (MediaLab). · Ensures compliance with applicable regulatory standards (CLIP/CLIA, CAP, FDA, ISO); serves as primary contact for regulatory audits and help prepare and submit necessary documentation and responses. · Oversees and maintains the Internal Audit Program. · Oversees and maintains the Document Control and Record Retention programs, including maintaining a centralized documentation system for all records, ensuring that data and records are securely stored, easily accessible, and meet regulatory and organizational standards. · Oversee and maintain the nonconforming event system, including investigation of complaints, conducting root cause analyses for identified issues, and ensuring corrective and preventative actions (CAPA) are implemented effectively. · Provides training and orientation to new and existing laboratory staff on quality standards, regulatory requirements, and procedures. · Work with management to identify areas for process improvement and implement changes to enhance the quality of laboratory services. · Performs additional duties and responsibilities as assigned or directed by the supervisor, which may include attendance and participation in required training for the role. Requirements Qualifications • A bachelor’s degree in a science-related field., • One or more years of quality assurance experience., • Previous hands-on laboratory bench experience preferred., • Knowledge of Regulations: Strong understanding of CLIA/CLIP/CAP regulations and other relevant federal and state guidelines., • Quality Systems: Expertise in developing and implementing Quality Management Systems., • Auditing Skills: Experience in conducting internal and external audits., • Analytical Skills: Ability to analyze data, identify trends, and conduct root cause analyses., • Communication Skills: Effective communication for reporting findings, training staff, and collaborating with teams and management., • Attention to Detail: Meticulous approach to documentation, data review, and process monitoring., • Ability to work effectively with cross-functional teams, including researchers, laboratory staff, and auditors., • QA/QC Specialist to be able to help with any standardization of clinical trials documentations and SOPs if needed., • US Citizenship and the ability to obtain and maintain a T3/Secret Clearance. Benefits MPF Federal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. We offer a competitive compensation package including a competitive salary, medical benefits, PTO, holiday pay and more.

Job Description About Company: Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally. Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge. Location: Miami (Onsite) Job Description: This role is based at our largest site, Clinical Pharmacology of Miami (CPMI). The Director’s primary role is for ensuring that day-to-day clinical trial operations at the CPMI site are conducted in compliance with study protocols, FDA regulations, and ICH/GCP guidelines. This role provides oversight and reporting to Operational Leadership to maintain the integrity and quality of all site activities. This is a leadership role, and the ideal candidate will have experience mentoring and leading others. Oversight and communication with the Operational Team may include (but is not limited to): • Conducting internal audits, • Monitoring training completion and associated metrics, • Providing support and consultation for Quality events and CAPAs, • Overseeing and assisting with internal and external audits, • Managing and supervising Quality Control plans and QC staff As needed, or in the absence of the Vice President of Quality Assurance, this role may assume leadership of the ERG Corporate QA Team, oversee the planning, execution, and analysis of Quality Assurance initiatives, as well as managing external audits for the organization. This position reports directly to the Vice President of QA. In fulfilling these responsibilities, the CPMI-based Quality Assurance and Compliance Director operates in alignment with FDA regulations, Good Clinical Practice (GCP) guidelines, and the company’s standard operating procedures and policies. Responsibilities: Quality Management of the Clinic • Lead and conduct audits of study documents, Case Report Forms, Clinical Study Reports, and other supporting documentation to ensure compliance, • Collaborate with Site Director and study PIs to resolve and document issues promptly and effectively, • Conduct GCP compliance audits of vendors in accordance with Standard Operating Procedures, • Report significant Quality issues to Vice President, Quality Assurance, • Oversee the implementation of corrective actions with support of the Site Director and VP of Quality, • Responsible for facilitating Sponsor Audits and assisting with other Sponsor site visits as applicable (and to report results of audits to Vice President, QA), • Assist with supporting Regulatory (FDA, EMA, etc) Inspections and preparation activities, • Oversee training is conducted in accordance with SOPs and reports metrics to Operational Leadership for required management and next steps., • Responsible to oversee all Document Control activities for the site, and for other sites as requested from the VP of QA., • Ensure the appropriateness and effectiveness of site CAPA investigations and oversee timely and accurate reporting of results to applicable stakeholders, including Sponsors, CROs, and IRBs., • Responsible to fully manage all aspects of the electronic Quality Management System as it applies to CPMI (and to ERG as a whole under the direction of the VP of Quality)., • Play a key role in site leadership and client engagement, ensuring clear communication, professionalism, and alignment with Operational Leadership and the Quality Assurance Department., • Member of a professional team focused on clinical quality assurance/quality control and compliance-related activities in support of clinical programs and activities., • Assist in maintaining ERGs Quality Management System (QMS), inclusive of the eQMS, to ensure compliance to Good Clinical Practice (GCP) and that the QMS is aligned with the internal policies and standard operating procedures for ERG., • Assist in audit activities in the areas of Vendor Audit Management, facilitation of internal & external clinical quality audits, and agency inspections, • Participate in the oversight of Corrective and Preventive Actions (CAPA) implementation and assist in conducting Quality reviews., • Perform any other tasks/duties assigned by VP QA, • Education and experience, • Thorough understanding of Good Clinical Practices (GCP), Code of Federal Regulations (CFR), and HIPAA as they apply to clinical research., • Bachelor’s degree or higher in life sciences, medicine, or a related field (or equivalent experience)., • Bilingual Spanish highly preferred, • Minimum of 10 years in the pharmaceutical, clinical, or medical device industry, including conducting internal and external audits., • At least 5 years of experience participating in FDA or other regulatory agency inspections (preferred)., • Extensive experience managing CAPA programs with a focus on GCP compliance, ensuring timely completion and deliverables., • Background in project management, site leadership, or oversight of high-volume clinical trials strongly desired., • Experience with 21 CFR Part 11 and aspects of Computer System Validation (preferred but not required)., • Requirements, • Strong understanding of FDA regulatory requirements, Good Clinical Practice (GCP), and International Conference on Harmonization (ICH) guidelines., • Knowledge of medical terminology., • Excellent organizational and prioritization skills with the ability to adapt in a dynamic, changing environment., • Strong analytical and problem-solving abilities., • Ability to provide accurate guidance and support on regulatory requirements., • Excellent documentation practices and attention to detail., • Ability to travel as requested by the Vice President of QA., • Exceptional communication skills (interpersonal, written, and verbal)., • Proficiency in computer applications, including Microsoft Word and Excel, and familiarity with clinical research systems (e.g., Clinical Trial Management Systems).

Job DescriptionSalary: $97,000 - $120,000 annually. Exact compensation may vary based on skills and experience. About Artiva: Artiva is clinical-stage, publicly-traded biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers. Artivas lead program, AlloNK, is an allogeneic, off-the-shelf, non-genetically modified NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. AlloNK is delivered in the outpatient setting with no required hospitalization. AlloNK is currently being evaluated in three ongoing clinical trials for the treatment of B-cell driven autoimmune diseases. This includes two company-sponsored trials, one in systemic lupus erythematosus for patients with or without lupus nephritis, and a basket trial across autoimmune diseases (Rheumatoid Arthritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathies and Sjgrens Disease), as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases. Artivas pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers. Artiva was founded in 2019 as a spin out of GC Cell, formerly GC Lab Cell Corporation, a leading healthcare company in the Republic of Korea, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia and New Zealand) to GC Cells NK cell manufacturing technology and programs. Artiva is headquartered in San Diego, California. For more information, visit. Job Summary:The Manufacturing Quality Specialist will serve as the primary interface between Manufacturing (MG) and Quality, ensuring compliance, documentation accuracy, and continuous improvement across manufacturing operations. This roleis responsible forquality event ownership, document control, training oversight, and data analysis to support CMC activities.The ideal candidate willdemonstratein-depth knowledge of cGMP compliance,will be a self-starter,andcanwork independently to achieve corporate objectives.This is a full-time position reporting to theAssociateDirector of Manufacturingand islocatedat our corporate headquarters in San Diego, CA. Duties/Responsibilities: • Serve as the primary liaison between Manufacturing (MG) and Quality, ensuring alignment on quality expectations, investigations, and resolutions., • Act as the primary author and owner of quality events, including, but not limitedtoDeviations, Corrective and Preventive Actions (CAPA),Nonconformance Material Reports (NCMR),andChangeControls., • Manage and execute document revisions and lifecycle managementofManufacturing documents, includingMaster Batch Records (MBR),EquipmentProcedures(EQT),Standard Operating Procedures (SOP),Standard Forms (SFM),Work Instructions (WRK), andTrainingDocuments(TLT)., • Maintain training and qualification tracking for manufacturingandcleaning contractpersonnel, • Author and review APV reports and other manufacturing quality documentation, • Execute and support Master Batch Record (MBR)and logbookreviewto ensurecompleteness,accuracy,andcompliance., • Perform data tracking, analysis, and trending across CMC functions., • Support continuous improvement initiatives byidentifyingtrends, risks, and opportunities for process and compliance enhancement. Requirements: • Bachelors degree in relevant science or engineering discipline, or equivalent workexperience., • Minimum 5 years of experienceincGMPbiologicsorcellculturemanufacturing., • Experience in biotech or cell therapy manufacturingis preferred., • Asepticgowning andmanufacturinginan ISO/Grade clean room environment., • Strong knowledge of GMP manufacturing and quality systems., • Excellent technical writing and documentation control skills., • Experience with quality investigations and root cause analysis., • Strong cross-functional communication and stakeholder management., • Data analysis and reporting skills., • Knowledge of cGMP regulations and FDA guidance applicable to biologics and celltherapymanufacturing., • Willingness to think outside of the box and adapt best practices to our small, but growing environment., • Ability to adaptina constantly evolving environment., • Self-motivated witha strong senseof ownership in areas of responsibility., • Excellent organizational skills and an ability to prioritize effectivelyto deliverresults withinreasonably establishedtimelines., • Experienceinthefollowingpreferred:, • Cell counting on various platforms., • Cellculture andexpansionusingbag systems,singleuselarge scalebioreactors, and others where applicable. Sartorius systems experience a plus., • Cellharvesting andwashingprocesses,bothautomatedand manual., • Cellselectionand depletiontechniques usingMiltenyiCliniMACSProdigy., • Fill finish and Cryopreservationprocessesandequipment. In addition to a great culture, we offer: • A beautiful facility, • An entrepreneurial, highly collaborative, and innovative environment, • Comprehensive benefits, including:, • Medical, Dental, and Vision, • Group Life Insurance, • Long Term Disability (LTD), • 401(k) Retirement Plan, • Employee Assistance Program (EAP), • Flexible Spending Account (FSA), • Paid Time Off (PTO), • Company paid holidays, including the year-end holiday week, • Our recognition program, Bonus.ly, is where you can trade in points earned for things you want. If all this speaks to you, come join us on our journey!

Job DescriptionSalary: About Artiva: Artiva is clinical-stage, publicly-traded biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers. Artivas lead program, AlloNK, is an allogeneic, off-the-shelf, non-genetically modified NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. AlloNK is delivered in the outpatient setting with no required hospitalization. AlloNK is currently being evaluated in three ongoing clinical trials for the treatment of B-cell driven autoimmune diseases. This includes two company-sponsored trials, one in systemic lupus erythematosus for patients with or without lupus nephritis, and a basket trial across autoimmune diseases (Rheumatoid Arthritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathies and Sjgrens Disease), as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases. Artivas pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers. Artiva was founded in 2019 as a spin out of GC Cell, formerly GC Lab Cell Corporation, a leading healthcare company in the Republic of Korea, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia and New Zealand) to GC Cells NK cell manufacturing technology and programs. Artiva is headquartered in San Diego, California. For more information, visit. Job Summary: Artiva Biotherapeutics is seeking a skilled and motivated Senior Quality Control Associate who will be reporting to the Sr. Manager, Quality Control of Raw Materials. This individual will support the Raw Materials program with development of new methods or procedures for raw materials testing, coordinating out-sourced testing and working with Sample Management for timely testing turnaround to meet critical material release for manufacturing Artiva products. Duties/Responsibilities: • Perform and verse GMP testing of raw materials, including but not limited to identity, sterility, endotoxin, bioburden, mycoplasma, pH, osmolality, and compendial testing, • Execute material qualification activities for new vendors, materials, and alternate suppliers, • Review and approve raw material test results and disposition materials in accordance with internal procedures, • Ensure timely testing and release to support manufacturing schedules, • Author, review, and approve GMP documentation including SOPs, test methods, protocols, reports, deviations, CAPAs and change controls, • Maintainer accurate and compliant laboratory records in LIMS, ELN, and paper-based systems, • Support internal, external, and regulatory audits (FDA, EMA, etc.), • Act as a subject matter expert (SME) for raw material testing methods and regulatory expectations, • Troubleshoot assay failures, out-of-specification (OOS, and out-of-trend (OOT) results, • Lead or support method transfers, verifications, and validations for raw material assays, • Evaluate supplier documentation including BSE/TSE, CoAs, COC, COI, technical packages, SDS and quality agreements, • Identify opportunities to improve testing efficiency, data integrity, and compliance, • Support implementation of new technologies, methods, and systems, • Participate in cross-functional teams with QA, Manufacturing, Materials Management and Product Development, • Coordinate sample shipments for contract testing labs for quality control., • Support or lead QC special projects as needed Qualifications: • BS or BA or a relevant scientific field, preferably biology or a related field., • At least 4 years of cGMP QC experience in a cell therapy/biotech/pharmaceutical setting is required., • Strong knowledge of raw material testing requirements and regulatory expectations (USP, EP, ICH), • Experience with cell therapy-relevant materials (media, cytokines, sera, reagents, consumables), • Experience with compendial and non-compendial methods, • Knowledge and experience in supporting cGMP deviations, OOS, etc., • Basic knowledge of method transfers, qualifications, and validations; current industry practices; and strong experience with guidance interpretation and application, • Excellent critical thinking and technical writing skills., • Computer skills required to operate Microsoft Word, Project, Visio, and Excel programs If all this speaks to you, come join us on our journey! Base Salary: $96,000 - $110,000. Exact compensation may vary based on skills and experience.

Job DescriptionCompany Description Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application! At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients. Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team: • Competitive compensation for your work, • Generous time off policy, • Opportunity to broaden your horizons by attending popular conferences, • Emphasis on work/life balance, • Collaborative and team-oriented environment, • Making a positive impact to help ultra-rare disease patients who are in need of life saving treatmentsJob Description The QA Manager, GCP is responsible for: * Ensuring quality oversight and quality assurance and quality by design activities related to GCP/GCLP area * Guide and support from a quality perspective the GCP/GCLP and GPP related activities within Sobi, including audits, inspection and support of and risk assessment of the BLA/NDA/IND/CTA submissions under global umbrella. * Support the collection of the data needed for Audit program risk assessment * Support from quality perspective the clinical studies related activities across Sobi * Ensure qualification of global and local ESP, as applicable, in GCP regulated area per Sobi procedures * The employee will in this role work with relevant stakeholders across the Sobi organization. Key responsibilities: * Ensure GCP Audits management excellence of the end to end audit management process and overview of the assigned audits, as planned * Asses and approve from quality perspective the GCP deviations (global and local, as applicable), GCP related CAPAs. * Prepare regular status report on performed audits, audit trending, deviation ternding, CAPAs trending and agreed upon metrics to ensure Quality oversight. * Contributeand support the GCP audit risk assesment according to SOPs. * Ensure active contribution in the cross-functional team with procurement, business owners for GxP and Quality requirements and documented qualification of GCP service providers and review provisions in contracts/Quality agreements, as applicable * QA representative during GCP inspections global and site level, as applicable and contribute to the Inspection Readiness framework and promote continuously quality mindset across Sobi. * Authoring GCP QA related processes, review and give guidance under global umbrella. Qualifications Required: * University degree or similar in Life Sciences or related discipline. * At least 5 years experience from the pharmaceutical industry in Clinical Quality Assurance or in the operational conduct of clinical trials and the application of GCP audit and/or Quality Assurance experience. Technical skills: * Excellent knowhow of the applicable ICH GCP guidelines, industry best practices and FDA, EMA and ROW regulatory requirements. * Quality assurance activities principles and know-how * Documented education/experience in QA systems and preferably auditing Soft skills: * Structured with focus on results and detail oriented * Strong interpersonal skills with communicative and flexible attitude * Proactive and collaborative mindset * Strong multi-tasking abilities with high resilience at stress and adaptative skills Additional Information Compensation and Total Rewards at Sobi At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards. The base salary range for this role is $112,000-$153,000. Each individual offer will be determined based on several factors, including your experience, qualifications, and location. Additionally, this role is eligible for both short-term and long-term bonuses, as outlined in the plan details. All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease. Why Join Us? We are a global company with over 1,900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you. We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff. Sobi Culture At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them. As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth. An Equal Opportunity Employer Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to Know Your Rights