Clinical trials management jobs in San Diego, California - Page 2Create job alerts

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 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 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 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 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

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: 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 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 DescriptionAbout Us Modena Health ("MH") and Modena Allergy & Asthma ("MAA") are leading and rapidly growing medical practices specializing in allergy, asthma, and immunology care, with clinics across Southern California and Arizona—and ambitious plans for national expansion. We are physician-led, hospitality-focused, and technology-enabled, committed to transforming allergy care while advancing clinical research and expanding access to cutting-edge medicine. Known for our high standard of excellence, we provide compassionate, patient-centered care for both pediatric and adult patients. Our model combines hospitality-driven service with innovative technology solutions that streamline operations, improve clinical outcomes, and enhance the experience for both patients and providers. At Modena, we aim to hire great people, treat them well, and help them find meaning and purpose in our mission. Our dedicated team values collaboration, positivity, and growth while striving to improve lives through expert diagnosis, treatment, and research. We are looking for high-energy, kind, and collaborative individuals eager to grow personally and professionally while making a meaningful impact in the lives of others. Position Summary We are seeking a highly skilled and compassionate Allergist/Immunologist Physician to join our growing practice in Greater San Diego, Greater South Bay LA, & New Prospect Locations. As a key member of our healthcare team, you will be responsible for diagnosing and treating patients with a wide range of allergic and immunologic conditions. You will provide high-quality care, collaborate with other medical professionals, and have the opportunity to work in a patient-centered, multidisciplinary environment. The ideal candidate must be a self-motivated and eager individual who will establish him/herself in a practice that enjoys continuous growth. Must have excellent communication skills, bedside manner, and a strong work ethic with a desire to be part of a team that is committed to caring for the whole patient. We place special emphasis on providing patient-centered care, quality outcomes and patient satisfaction. If you are a dedicated and caring Allergist/Immunologist with an interest in advancing the field through clinical research and looking to make a difference in the lives of patients, we encourage you to apply. This is a unique opportunity to shape the future of allergy and immunology care while contributing to groundbreaking research in a collaborative and supportive environment. This role is exempt (salary) and full-time, working 40 hours per week, Monday through Friday with minimal travel. Key Responsibilities • Clinical Responsibilities, • Diagnose, treat, and manage patients with allergies, asthma, immunologic conditions, and related diseases., • Conduct comprehensive patient evaluations, including medical history, physical exams, and appropriate diagnostic tests (e.g., skin tests, blood tests, pulmonary function tests)., • Develop and implement individualized treatment plans, including medication management, immunotherapy, and lifestyle modifications., • Educate patients and their families about managing allergies, asthma, and immunologic conditions., • Perform procedures such as allergy skin testing, spirometry, and immunotherapy (allergy shots)., • Oversee in-office oral food challenges, drug challenges, and immunotherapy treatments (oral immunotherapy and sublingual immunotherapy for environmental and food allergy), • Develop and implement individualized care plans based on patient needs and medical history, including:, • Starting allergy immunotherapy for environmental allergies, • Starting oral immunotherapy for food allergy, • Recommending food or drug challenges as part of allergy evaluation, • Collaborate with other specialists (e.g., pulmonologists, dermatologists, primary care physicians) to ensure comprehensive care for patients., • Maintain accurate and up-to-date medical records in compliance with healthcare regulations and confidentiality standards., • Stay informed about the latest advancements in allergy and immunology treatments and participate in continuing medical education (CME)., • Ensure high patient satisfaction and provide empathetic care, focusing on patient education and wellness., • Additional duties as assigned., • Research Responsibilities, • Engage in clinical research initiatives through Orso Health, Modena Health's research arm, related to the diagnosis, treatment, and prevention of allergic and immunologic diseases, or other areas of clinical interest., • Participate in designing and conducting clinical trials, including trials on new therapies, biologic treatments, and immunotherapy options., • Analyze data, prepare research reports, and collaborate with research teams to publish findings in medical journals., • Contribute to the development of innovative clinical pathways and treatment strategies based on research findings., • Work closely with industry partners, academic institutions, and research foundations to advance clinical studies in allergy and immunology., • Provide mentorship and guidance to junior researchers interested in allergy and immunology research., • Present research findings at national and international conferences., • Additional duties as assigned.Qualifications & Requirements, • Education, • Doctor of Medicine (MD) or Doctor of Osteopathic Medicine (DO) degree from an accredited medical school., • Experience, • Completion of an accredited residency in Internal Medicine or Pediatrics., • Successful completion of a fellowship in Allergy and Immunology., • Board certified or board eligible in Allergy and Immunology., • 1–3 years of post-fellowship clinical experience preferred; will consider highly qualified new fellowship graduates., • Demonstrated experience in diagnosing and managing patients with allergies, asthma, and immunologic conditions., • Hands-on experience performing and interpreting allergy testing, spirometry, and administering immunotherapy, • Licensure & Certifications, • Board certification or eligibility in Allergy and Immunology (ABAI)., • Valid and unrestricted medical license to practice in California., • Skills & Abilities, • Strong knowledge of allergy, asthma, and immunologic diseases and treatments., • Interest and experience in clinical research, including trial design and data analysis., • Excellent communication and interpersonal skills, with the ability to build rapport with patients and their families., • Ability to work effectively both independently and as part of a collaborative healthcare team., • Compassionate and patient-centered approach to care., • Preferred Qualifications, • Experience in a clinical or private practice setting., • Bilingual in Spanish (preferred but not required)., • Expertise in immunotherapy and biologic treatments for allergy and asthma., • Experience in writing research protocols, grant submissions, or publishing research., • Competitive salary and benefits package, including medical, dental & vision insurance, 401(k) retirement plan with employer matching, and professional development opportunities, • In addition, we offer paid time Off (PTO), sick time, floating holiday and holiday pay, • Opportunity to shape the future of a thriving allergy and asthma practice in beautiful San Diego (and across our expanding network) California Consumer Privacy Act (CCPA) Notice Modena Health ("MH") and Modena Allergy & Asthma ("MAA") complies with the California Consumer Privacy Act ("CCPA"). Personal information provided in the job application process will be collected, used, and retained in accordance with applicable privacy laws. Candidates may request additional information regarding the categories of personal information collected and the purposes for which it is used during the hiring process.

Job Description POSITION SUMMARY: Performs study-related clinical procedures according to the study protocol and provides care under appropriate supervision for subjects enrolled in clinical trials. Performs duties in accordance with ProSciento’s values, policies, and procedures. This role should be available for the 3 shifts offered: (1) 6am-2:30pm PT (2) 2pm-10:30pm PT and (3) 10pm-6:30am PT. DUTIES AND RESPONSIBILITIES: • Understands the main objectives of each ongoing study and the study procedures for which he/she will be responsible., • Demonstrates proficiency at performing basic clinical procedures such as vital signs, ECGs, phlebotomy, and sample processing., • Demonstrates proficiency in documenting observations and study procedures correctly and legibly in the source document., • Understands and demonstrates proficiency in appropriately responding to medical emergencies onsite., • Performs study procedures as assigned., • Observes and records data related to patient safety and study procedures., • Ensures that all study data is recorded accurately and completely., • Assists nursing staff and Clinical Project Managers with study procedures and patient management as directed., • Assists in the transcription of study data from source documents to Case Report Forms (CRFs)/ (eCRFs)., • Understands and complies with Good Clinical Practices (GCPs), particularly those regarding the protection of human subjects and integrity of clinical trial data., • Understands and complies with ProSciento Standard Operating Procedures (SOPs) and Work Instructions (WIs)., • Participates as requested in ProSciento Continuous Quality Improvement (CQI) process., • Flexibility to work mornings, evenings, and/or overnight shifts as needed., • Attends and participates in all required training activities., • Participates as requested as a Clinical Operations Study Liaison., • Assists with Screening Receptionist duties and responsibilities as requested., • Assists with Recruitment duties and responsibilities as requested. JOB REQUIREMENTS / QUALIFICATIONS/EDUCATION: Qualifications: To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education and Experience: High school diploma or general education degree (GED) as well as experience as a Medical Assistant, EMT, LVN, Phlebotomist, Foreign Medical Graduate (FMG), or Corpsman in a clinical or laboratory setting and/or equivalent combination of medical education, training, certifications, and/or experience. KNOWLEDGE, SKILLS, AND COMPETENCIES REQUIRED Skills, Knowledge, and Abilities: Able to perform basic clinical procedures correctly including vital signs, ECGs, and sample processing. Demonstrates initiative and problem-solving skills. Able to respect subject confidentiality and blinding procedures. Understands medical terminology and calculations. Demonstrates a strong attention to detail with superior organizational skills. Under general supervision, exercises judgment in accordance with well-defined policies, procedures, and techniques. Able to self-monitor progress and complete assigned tasks independently. Competencies: • Functional/Technical Skills: Has the functional and technical knowledge and skills to do the job at a high level of accomplishment., • Peer Relationships: Can quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers., • Process Management: Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient workflow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can’t; can simplify complex processes; gets more out of fewer resources., • Action Oriented: Enjoys working hard; is action oriented and full of energy for the things he/she sees as challenging; not fearful of acting with a minimum of planning; seizes more opportunities than others., • Basic Life Support (BLS) certification is required and may be provided by the company. GCP training is required and will be provided by the company. Language Skills: • Must be proficient in both verbal and written English. Able to communicate effectively with both employees and management. Ability to read and interpret documents such as safety rules, WIs, SOPs, medical terminology, and procedure manuals. Math Skills: • Able to add, subtract, multiply, and divide in all units of measure using whole numbers, fractions and decimals. Able to compute rate, ratio, and percent and to draw and interpret bar graphs. Reasoning Skills: • Ability to apply common sense understanding to carry out instructions provided in written, oral or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. Computer Skills:

Job Description Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer's most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. The name "Erasca" has an important embedded meaning: it is a contraction of our audacious hope to "erase cancer" that drives our mission and everything that we do on behalf of patients with cancer. Position Summary: Reporting to the CMO, the VP Global Pharmacovigilance has overall responsibility for drug safety activities for early and late phase assets, including furthering the development and implementation of the clinical development strategy. The VP will be accountable for overseeing safety and pharmacovigilance across development and expected global launches and, ultimately, post-marketed products. The VP must possess a strong knowledge of global pharmacovigilance regulations, operational efficiencies, information systems, and best industry practices to effectively solve challenges and facilitate PVG compliance. Note this position can be hybrid in our San Diego or South San Francisco locations or fully remote anywhere in the United States. Essential Duties and Responsibilities: • Provide Safety Science leadership for clinical development programs and program teams and integrate safety science strategy with clinical development., • Represent GPV in communication with health and regulatory authorities., • Represent GPV at independent Data Safety Monitoring Committee meetings., • Provide medical oversight of the GPV function including medical review of all cases., • Provide medical input for maintaining REMS, RMP safety monitoring commitments., • In collaboration with other members of GPV, create and maintain a signal detection process for Erasca's products with a clearly defined signal detection strategy for each asset., • In collaboration with other members of GPV, ensure robust processes are implemented to meet REMS/RMP commitments., • Overall responsibility for development and implementation of QPV, in collaboration with Quality and GPV Systems., • Provide periodic benefit-risk assessment reports for internal use., • Contribute to the preparation of, review, and approve aggregate safety reports required by health authorities., • Serve as SME author, reviewer, and approver for drug-safety related regulatory reports and clinical study documents (including clinical study protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), product package labeling, Company Core Safety Information, etc)., • Work with external partners to jointly manage cases, safety reporting, and signal detection across global development for molecule candidates., • Manage implementation and/or operation of data analytics and data reporting tools to support drug safety compliance and analysis., • Build and lead highly functioning GPV team including Safety Operations and Safety Science, utilizing internal and external resources., • Develop operating plans and budgets and allocate resources to ensure budgets, schedules, and performance requirements are met., • Assess process, systems, and staffing needs to scale for multiple late-stage trials, including oversight of CROs and vendors., • Develop and maintain relationships across Erasca, particularly in Clinical Development, Clinical Operations, Biometrics, and Regulatory Affairs., • Doctor of Medicine or x-US equivalent with industry experience in safety science for oncology clinical development required; PharmD or other relevant clinical degree may be considered., • 12 or more years of experience in the biotechnology or pharmaceutical industry with knowledge of GCP, clinical trial conduct, data interpretation, and safety in clinical development. A mix of large and small company experience highly preferred., • Excellent scientific and clinical and analytical knowledge base, with the ability to assess data and understand safety and medical implications., • In-depth knowledge of clinical research, including FDA and international regulations, clinical study design, and documentation., • Experience with early clinical development required; experience in late-stage clinical development and NDA or BLA submission preferred., • Extensive experience interfacing with US (FDA) and x-US health authorities required. Experience executing clinical trials in China, reporting safety data to China health authorities preferred., • In depth knowledge of Safety Science and Safety Operations disciplines, with exposure to both internally and externally managed safety systems and databases., • Direct management experience with proven ability to effectively lead, coach, mentor, and manage others., • Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment., • Effective interpersonal, communication and influencing skills, including excellent writing skills; must be a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex technical problems. Along with our casual, collaborative, and fun work and the chance to make your mark in our mission to erase cancer, Erasca offers a comprehensive and competitive benefits package that includes: Paid Time Off, Holiday, and Sick Leave, Medical, Dental and Vision Plans, Short- and Long-Term Disability, Basic and Voluntary Life/AD&D Coverage, Flexible Spending Accounts (FSA, HSA, and Commute), Critical Illness and Accident Coverage, Pet Insurance, Employee Assistance Program, 401(k) Plan with Erasca contribution, and the opportunity to participate in an Employee Stock Purchase Program. Erasca, Inc., is an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of sex , race, religion, national origin, ancestry, physical or mental disability, protected medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military and veteran status or any other basis protected by federal, state or local law or ordinance or regulation.

Job Description Director, Clinical Project Management (Remote) Position Summary The Director of Project Management will oversee and drive the execution of global clinical trials in oncology. This leadership role is responsible for ensuring the successful planning, implementation, and completion of complex clinical programs, collaborating with cross-functional teams and external partners worldwide. Key Responsibilities • Lead the strategic planning and operational execution of global oncology clinical trials, ensuring projects are delivered on time, within scope, and budget., • Work with cross-functional project teams, including Clinical Development, Clinical Operations, Regulatory Affairs, CMC, Data Management, and external vendors., • Develop and maintain detailed project plans, timelines, and risk management strategies for all assigned studies., • Monitor trial progress, proactively identify issues, and implement solutions to ensure quality and regulatory compliance., • Contribute to process improvement initiatives and best practices in global project management., • Work closely with other professional project managers who work in our early stage development programs. Education & Qualifications • Bachelor’s degree in life sciences, healthcare, or related field; advanced degree (MS, PhD, MBA) preferred., • Minimum of 8 years’ experience managing global clinical trials in oncology, with demonstrated leadership in complex, multi-center studies and global regulatory submissions., • Proven track record in project management within the biopharmaceutical industry., • Strong understanding of regulatory requirements (FDA, EMA, ICH-GCP) for global clinical development., • Ability to travel domestically and internationally as required. Technical / Soft Skills • Exceptional communication, organizational, and leadership skills., • 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 Vivo HealthStaff is recruiting for a Clinical Trials Physician for a Vaccine Trial in the USA. We are seeking an experienced and licensed Pain Management Physician to provide locum tenens coverage at multiple clinic locations across the USA. The ideal candidate is board certified, has a current medical license, and is looking for contract work. Position Details: Specialty: Clinical Trials Start Date: [Flexible Based on Availability] Contract Length: 3-12 months, with extension potential Schedule: 1-2 days per week Call: No call required Practice Setting: Outpatient clinic Locations Available: * Washington DC * San Diego, CA * Denver, CO * San Jose, CA Responsibilities: * Evaluate patients for a vaccine trial * Collaborate with clinic staff and specialists for comprehensive clinical trial * Use EMR for documentation Requirements: * Active and unrestricted Medical License * Active DEA registration * Prior experience in Clinical Trials Compensation & Benefits: Pay Rate: Competitive hourly rate Payment: Weekly direct deposit Insurance: Malpractice insurance provided Support: Dedicated recruiter assistance throughout the assignment Onboarding Process: Expedited credentialing available Assistance with compliance and facility paperwork Orientation provided before the start date About Vivo HealthStaff: Vivo HealthStaff is a locum tenens staffing firm specializing in placing healthcare professionals in temporary and long-term assignments across the United States. We are committed to providing seamless placement experiences for providers and healthcare organizations.

Job Description POSITION SUMMARY: Participates in and assists in supporting the laboratory aspects of human clinical trials under the direction of the Laboratory Supervisor. Performs laboratory procedures while ensuring the integrity of the studies and the safety and well-being of human subjects. Performs duties in accordance with ProSciento’s values, policies, and procedures. DUTIES AND RESPONSIBILITIES: • Participates in day-to-day clinical and laboratory activities and procedures, ensuring efficient workflow, appropriate collection and management of research subjects’ laboratory samples, and adequate care and treatment of research subjects, maintaining quality control of specimen samples. Supports the laboratory with COVID-19 sample collections, testing, and procedures., • Serves as point of entry for all specimens coming to the laboratory. This entails processing all specimens, completing requisition forms, shipment of samples, and logging in samples on laboratory tracking logs according to procedures provided in study protocols and manuals., • Provides lab support including kit preparation, sample labeling, specimen preparation, sample inventory, appropriate storage, and specimen shipping, and helps to resolve laboratory requisition or sample queries from reference labs., • Assists with receipt and inspection of protocol specific supplies and with ordering and stocking of general materials and equipment, and assists with inventory and stocking of laboratory, clinical, and office supplies and consumables. To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education and Experience: • High school diploma or general education degree (GED) plus three months health service industry experience, and/or training in a laboratory, research, or clinical environment. Competencies: • Able to perform basic clinical procedures correctly including vital signs, ECGs, phlebotomy, and sample processing. Demonstrates initiative and problem-solving skills. Able to respect subject confidentiality and blinding procedures. Understands medical terminology and calculations. Demonstrates a strong attention to detail with superior organizational skills with ability to deal with large volumes of data and/or samples while maintaining efficiency and accuracy under tight deadlines. Under general supervision, exercises judgment in accordance with well-defined policies, procedures, and techniques. Able to self-monitor progress and complete assigned tasks independently., • Action Oriented: Enjoys working hard; is action oriented and full of energy for the things he/she sees as challenging; not fearful of acting with a minimum of planning; seizes more opportunities than others., • Functional/Technical Skills: Has the functional and technical knowledge and skills to do the job at a high level of accomplishment., • Priority Setting: Spends his/her time and the time of others on what’s important; quickly zeros in on the critical few and puts the trivial many aside; can quickly sense what will help or hinder accomplishing a goal; eliminates roadblocks; creates focus., • Process Management: Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient workflow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can’t; can simplify complex processes; gets more out of fewer resources. Must have Basic Life Support (BLS) and International Air Transport Association (IATA) certification and/or be willing to obtain certifications upon hire. Good Clinical Practices (GCP) training is required and will be provided by the company. Language Skills: Must be proficient in both verbal and written English. Able to communicate effectively with both employees and management. Ability to read and interpret documents such as safety rules, Work Instructions (WIs), Standard Operating Procedures (SOPs), medical terminology and procedure manuals. Reasoning Skills: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. Computer Skills: To perform this job successfully, an individual should have knowledge and proficiency in the current MS Office Suite, as well as Windows operating systems. This position requires open availability for shift scheduling, including the ability to work any of the following shifts on an as-needed basis: 1st Shift (Day), 2nd Shift (Evening), 3rd Shift (Overnight). Candidates must also be available to work weekends and holidays, as coverage during these times may be required to meet operational needs.

Job DescriptionJanux Therapeutics is seeking a Clinical Biomarker Lead to join our Translational group and contribute to the end-to-end planning and execution of clinical biomarker strategy for our early-stage clinical programs. This individual will closely work with the biomarker operations and research team to ensure timely clinical sample evaluation and generate data analytics strategy to derive critical insights from clinical trial data to inform strategic decision-making. The ideal candidate will bring an in-depth understanding of oncology and/ or immunology and clinical-translational research experience. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES • Lead end-to-end execution of the clinical biomarker strategy to support Janux’s oncology and autoimmune clinical programs, • Organize and maintain clinical biomarker and bioanalytical datasets and individual patient profiles for clinical programs., • Perform high throughput data analytics of, translational, and clinical datasets to identify and validate potential biomarkers of response/resistance to TRACTr, TRACIr, and/or ARM treatments., • Integrate functional biological readouts with patient’s clinicopathological features to contribute to patient selection strategies for clinical programs., • Collaborate with Biomarker and clinical operation teams to ensure end-to-end sample tracking and maintain oversight on all sample related timelines including subsequent data collection and distribution., • Manage multiple specialty vendor labs and maintain strong oversight on deliverables (proposals, timelines, experimental design, data analyses and reporting)., • Prepare and present data. Collaborate with internal Clinical Science and Research/ Immunology teams to evaluate data analytic approaches and ensure meaningful insights in the delivery. Perform in-depth scientific literature review to help address critical questions relating to target biology, clinical relevance, and associated assays., • Work cross-functionally with Research, Clinical and CMC teams to drive scientific programs and deliver critical insights to help inform decision-making across the portfolio. EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES, • Ph.D. in Immunology, Clinical/Health Sciences, Bioinformatics, or related scientific discipline with 4+ years of experience, preferably in an industry setting, with an emphasis in clinical biomarker analysis or translational medicine., • Strong understanding and experience working in immuno-oncology and/or solid tumor oncology with hands-on experience in designing, developing, and interpreting clinical biomarker datasets., • Competence with data analysis tools (Excel, GraphPad). Proficiency in data handling and visualization with R or Python is preferred., • Demonstrated ability to create impactful data visualization outputs and present meaningful insights., • Experience working with EDC systems and data listings is highly preferred., • Experience with Good Clinical Practice (GCP) principles and studies transitioning into clinical trials., • Experience working with external CROs (due diligence, proposals, oversight, project management, data analyses, and reporting) is highly preferred., • Strong analytical and critical thinking skills with the ability to work in a fast-paced environment. Excellent written and oral communication skills.In addition to a competitive base salary ranging from $150,000 to $163,000, we offer stock options, 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. 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.

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