Research Associate, Analytical Development-CONTRACT

🏢 Summary: MSAT Process Engineer role focused on improving and supporting GMP drug product manufacturing processes for clinical and commercial cell therapy products. The position includes process monitoring, troubleshooting, validation, change control, and continuous improvement activities in a biotechnology manufacturing environment. Shift-based work is required, with competitive benefits, bonus eligibility, and equity opportunities. 🗂️ Requirements: B.S. in Engineering or related field, 3+ years of manufacturing process and equipment experience, Experience in biologics, pharmaceutical, drug substance, chemical, or food manufacturing, Experience in regulated GMP manufacturing operations, Ability to perform process monitoring and troubleshooting, Ability to execute validation and change control activities, Strong problem-solving and communication skills, Flexibility to work outside standard business hours, Ability to meet cleanroom gowning requirements, 20/20 vision and normal color vision 📃 Skills: GMP, MSAT, Biotechnology, Celltherapy, Validation, Troubleshooting, CAPA, Manufacturing, Rootcause, Changecontrol, Batchrecords, Processmonitoring, Engineering 🏢 Description: More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With purified, high-precision investigational cell therapies, the company aims to replace patients' blood and immune systems with healthy ones and restore their lives. The company is establishing manufacturing operations on the East Coast to ensure the consistent and reliable delivery of high-precision cell therapy products. This site is essential to advancing the clinical pipeline and supporting future commercial availability of therapies. The MSAT Process Engineer works to improve the efficiency and safety of the drug product manufacturing process. This role is responsible for life cycle management of clinical and commercial products including process monitoring and troubleshooting, implementation and validation of process improvements and changes, and supporting investigations and corrective/preventive actions. Essential Duties & Key Responsibilities: - Performs ongoing monitoring of existing products and processes - Generate metrics and reports for process monitoring and continuous process verification - Support process improvements and changes including electronic batch record creation and modifications - Investigates process events and implements corrective and preventive actions - Provides troubleshooting support for manufacturing events, equipment performance and material issues - Performs root cause analysis to isolate cause of events and determine appropriate corrective actions - Authors, executes and owns change controls, technical protocols, reports and activities to support improvements - Writes and ensures proper execution of validation protocols and testing in line with required life cycle management activities Minimum Qualifications: - B.S. in Engineering or similar fields - 3+ years of experience with manufacturing processes and equipment in related fields: biologics, pharmaceutical fill and finish or drug substance manufacturing, chemical or food industries - Prior experience in regulated, GMP manufacturing operations - Experience in biotechnology and cell therapy manufacturing preferred - Strong communication and problem solving skills, with a desire to improve upon established processes - Flexibility to work outside standard business hours when needed to support site priorities, deadlines, or critical business needs 2nd Shift: - Monday - Friday, 4:00pm - 12:30am 3rd Shift: - Monday - Friday, 12:00am - 8:30am Physical Demands: - Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment - Most roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed - Use of cosmetics, jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed Benefits: - Eligible for pre-IPO equity and annual bonus - Competitive medical, dental, and vision benefits - PTO - 401(k) plan - Life and accidental death and disability coverage - Parental leave benefits

🏢 Summary: Manufacturing Process Lead role focused on cGMP production of clinical and commercial cell therapies in a regulated biotech manufacturing environment. The position oversees aseptic manufacturing operations, supports process optimization, supervises shift activities, and ensures compliance with quality and regulatory standards. The role includes equipment operation, documentation, troubleshooting, employee training, and continuous process improvement across 2nd or 3rd shift operations. 🗂️ Requirements: Bachelor’s degree in Biology, Engineering, or related science field, 2-3 years of GMP manufacturing, process sciences, or discovery experience, Experience with aseptic techniques, Knowledge of cell or gene therapy processes, Experience working with human cells, Familiarity with cell characterization methods, Familiarity with cell separation techniques, Ability to work in regulated cGMP environments, Ability to support non-standard business hours, Ability to meet cleanroom gowning requirements, 20/20 visual acuity and normal color vision 📃 Skills: cGMP, Aseptic, Celltherapy, Genetherapy, Cellseparation, Cellcharacterization, GMP, SOP, Biology, Engineering, Manufacturing, Troubleshooting, Documentation, Cleanroom 🏢 Description: More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. We are establishing manufacturing operations on the East Coast to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies. The Manufacturing Process Lead conducts cGMP manufacturing activities to produce clinical and commercial cell therapies and helps to optimize manufacturing processes. The Lead ensures adherence to quality standards, regulatory requirements, and aseptic production techniques. This position involves repeatedly executing manufacturing processes, cleaning and maintaining production equipment and workstations, and documenting production activities in a highly regulated environment. This position also entails on-shift oversight of production activities to ensure timely, efficient, and quality-driven execution of each day’s objectives. Essential Duties & Key Responsibilities: - Oversee execution of routine manufacturing and occasional scientific protocols - Develop and refine procedures for cell separation technologies, sterile connections, and aseptic techniques - Serve as subject matter expert for cell therapy processes and new technology - Provide verification for results and ensure detailed records are maintained - Prepare, maintain, trouble-shoot, and operate instruments - Plan the shift, including break management, shift pass downs, and process-appropriate decisions - Supervise in-room operations and delegate individual tasks based on operator capacity - Complete deviations - Escalate issues appropriately - Review and support continuous improvements of business processes, records, and SOPs - Training and coaching employees - Other duties as assigned Minimum Qualifications: - Bachelor’s degree in a science-related field (Biology, Engineering, etc.) or related field required; Master’s degree preferred - 2-3 years of experience in GMP Manufacturing, process sciences, or discovery - Experience with aseptic techniques - Familiarity with cell and/or gene therapy, including working with human cells, cell characterization methods, or cell separation techniques - Direct or indirect people leadership preferred - Flexibility to work outside standard business hours when needed to support site priorities, deadlines, or critical business needs 2nd Shift: - Monday - Friday, 4:00pm - 12:30am 3rd Shift: - Monday - Friday, 12:00am - 8:30am Physical Demands: - Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment - Must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods as needed - Use of cosmetics, jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed The anticipated annual salary range for this job is based on prior experience in the role or industry, education, location, internal equity, and other job-related factors as permitted by law. Full-time positions are eligible for pre-IPO equity, annual bonus, medical, dental, and vision benefits, PTO, 401(k), life and disability coverage, and parental leave benefits. We are driven by a passion for science and compassion for patients. We act with urgency to ensure treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for patients. We innovate on a path that hasn’t been paved, embrace an entrepreneurial spirit, and take calculated risks to achieve our mission. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We’re proud to be an equal opportunity employer and recognize that celebrating differences creates stronger, lasting solutions that better serve our team, patients, and healthcare providers.

🏢 Summary: Senior Manager / Associate Director, Biostatistics role providing strategic and operational statistical leadership across clinical development programs. The position leads study design, analysis, regulatory interactions, and cross-functional collaboration to support global submissions and evidence generation. This role influences development strategy, applies advanced statistical methodologies, and oversees statistical deliverables for clinical trials and post-marketing research. 🗂️ Requirements: PhD in Biostatistics, Statistics or related quantitative field with 4–6+ years industry experience OR MS with 6–8+ years industry experience, Experience providing statistical leadership for clinical development programs and clinical trials, Strong knowledge of clinical trial methodology, study design, statistical analysis, and regulatory requirements, Experience supporting regulatory submissions and health authority interactions, Experience leading cross-functional teams, Expertise in adaptive designs, longitudinal analyses, survival analyses, integrated analyses, Experience overseeing CROs and external statistical vendors, Proficiency in SAS and/or R, Strong understanding of ICH, FDA, EMA and global regulatory guidance 📃 Skills: SAS, R, Biostatistics, Statistics, ClinicalTrials, AdaptiveDesign, LongitudinalAnalysis, SurvivalAnalysis, IntegratedAnalysis, HEOR, RealWorldEvidence, ICH, FDA, EMA 🏢 Description: Position Summary: Senior Manager / Associate Director, Biostatistics to provide strategic and operational statistical leadership across clinical development programs. This individual will serve as the lead biostatistician for one or more clinical development programs and will partner closely with Clinical Development, Medical Affairs, Data Management, Statistical Programming, Regulatory Affairs, and external partners to ensure the delivery of high-quality statistical strategy, analyses, and regulatory submissions. The successful candidate will contribute to study design, protocol development, analysis planning, interpretation of clinical data, regulatory interactions, and evidence generation activities that support development, registration, and lifecycle management of programs. This role offers the opportunity to influence development strategy, advance innovative statistical methodologies, and contribute to regulatory and business decision-making. Essential Duties and Responsibilities: Statistical Leadership & Clinical Development - Lead the biostatistics strategy for one or more clinical development programs and studies. - Serve as the statistical representative on cross-functional study teams, Clinical Development Teams, and governance committees. - Collaborate with Clinical Development and Medical teams to design clinical studies aligned with program objectives, regulatory expectations, and business needs. - Provide strategic input into clinical development plans, including study design, endpoint selection, sample size determination, interim analyses, and decision criteria. - Identify potential statistical, operational, or scientific challenges and proactively develop solutions. - Evaluate and implement innovative statistical methodologies to enhance development strategies and study efficiency. - Support quantitative decision-making, including benefit-risk assessments, probability of technical success analyses, and Go/No-Go evaluations. Study Design, Analysis & Reporting - Author and/or review statistical sections of protocols, statistical analysis plans (SAPs), data review plans, and study reports. - Develop and/or oversee analysis strategies, including tables, listings, and figures (TLFs), ensuring methodological rigor and regulatory compliance. - Ensure timely delivery and quality of statistical analyses for interim reviews, final analyses, integrated summaries, and regulatory submissions. - Interpret study results and effectively communicate findings to technical and non-technical audiences. - Prepare and review abstracts, posters, manuscripts, presentations, and scientific publications. Regulatory & External Interactions - Contribute to regulatory strategies and support global submissions. - Represent Biostatistics during interactions with health authorities, including FDA, EMA, PMDA, and other regulatory agencies, as appropriate. - Support responses to regulatory questions related to study design, analysis methodologies, and interpretation of results. - Ensure statistical deliverables meet applicable ICH, FDA, EMA, and other global regulatory requirements. Medical Affairs, HEOR & Evidence Generation - Provide statistical leadership for post-marketing studies, observational research, registry studies, real-world evidence initiatives, and outcomes research activities, as applicable. - Support evidence generation strategies that address clinical, scientific, payer, and market access objectives. - Collaborate with cross-functional partners to identify evidence gaps and develop analytical approaches to address unmet evidence needs. - Contribute statistical expertise to publications, scientific communications, and evidence dissemination activities. Vendor Oversight & Operational Excellence - Oversee CROs, functional service providers, and external statistical vendors to ensure high-quality deliverables and adherence to timelines. - Collaborate with Statistical Programming and Data Management to ensure data quality and efficient execution of analyses. - Support departmental initiatives focused on process improvement, innovation, quality standards, and inspection readiness. - Contribute to the development and maintenance of statistical standards, procedures, and best practices. Required Education and Experience: Sr Manager: - Ph.D. in Biostatistics, Statistics, or a related quantitative discipline with a minimum of 4 years of pharmaceutical, biotechnology, or clinical research experience; or M.S. with a minimum of 6 years of experience. Associate Director: - Ph.D. in Biostatistics, Statistics, or a related quantitative discipline with a minimum of 6 years of relevant pharmaceutical industry experience; or M.S. with a minimum of 8 years of experience. - Demonstrated experience providing statistical leadership for clinical development programs and clinical trials. - Strong knowledge of clinical trial methodology, study design, statistical analysis, and regulatory requirements. - Experience supporting regulatory submissions and health authority interactions. - Experience leading cross-functional teams and influencing development strategies. - Expertise in statistical methods applicable to clinical development, including adaptive designs, longitudinal analyses, survival analyses, and integrated analyses. - Experience overseeing CROs and external statistical vendors. - Proficiency in SAS and/or R. - Strong understanding of ICH, FDA, EMA, and other global regulatory guidance. - Experience with real-world evidence, observational studies, HEOR, or post-marketing research is a plus. - Experience in immunology, inflammation, autoimmune disease, or related therapeutic areas is preferred.

🏢 Summary: Senior Scientist role focused on integrating human genetics, multi-omics, and real-world clinical data to support therapeutic target validation, patient stratification, and drug development. The position involves analyzing biobank-scale datasets, EHRs, and population data using computational and statistical methods in a cross-functional research environment. This onsite role in San Diego emphasizes translational genetics, RWE analytics, and scalable data workflows for precision medicine. 🗂️ Requirements: PhD in Biostatistics, Statistical Genetics, Epidemiology, Bioinformatics, Computational Biology, Biomedical Data Science, or related quantitative field, 3+ years of experience in human genetics, biomedical data science, or real-world data analytics, Experience with AI/LLMs for coding, data analysis, literature synthesis, and report generation, Experience working with biobank-scale datasets and real-world data sources, Strong background in statistical genetics, epidemiology, or observational data analysis, Experience integrating genetics, omics, and clinical datasets, Proficiency in R or Python, Ability to work in a fast-paced cross-functional research environment, Valid authorization to work in the country where the role is located 📃 Skills: R, Python, AI, LLMs, RNAi, EHR, OMOP, OHDSI, PheWAS, Biostatistics, Bioinformatics, Epidemiology, Genetics, Omics, MachineLearning, Statistics 🏢 Description: Arrowhead Pharmaceuticals, Inc. is a commercial stage biopharmaceutical company developing RNA interference (RNAi)-based therapies for diseases with a genetic basis. The company leverages RNA chemistries and delivery technologies to silence disease-causing genes and advance therapeutics across multiple disease areas. The Senior Scientist will contribute to the integration of human genetics, multi-omics datasets, and real-world clinical data to generate human evidence supporting therapeutic development. This role works at the intersection of translational genetics, computational biology, and real-world evidence analytics to support target validation, patient stratification, clinical endpoint evaluation, and indication prioritization across therapeutic programs. The successful candidate will collaborate closely with Translational Genetics & Data Science and cross-functional teams including Real-World Evidence, Clinical Development, Translational Medicine, and Discovery Biology. The role leverages large-scale biobank datasets, electronic health records (EHR), and other clinical datasets to translate human data into actionable insights supporting drug discovery and development. This position is onsite 5 days a week in San Diego. Responsibilities - Integrate human genetics, multi-omics datasets, and real-world clinical data to generate evidence supporting therapeutic target validation and indication prioritization - Analyze large-scale biobank and population datasets to identify genetic associations and disease mechanisms relevant to therapeutic programs - Collaborate with the Real-World Evidence (RWE) team to analyze clinical datasets including electronic health records (EHR), claims databases, registries, and longitudinal cohort data - Conduct statistical and computational analyses to characterize disease progression, patient heterogeneity, and treatment outcomes using real-world datasets - Translate genetic findings and clinical observations into hypotheses that inform biomarker strategies, patient stratification, and clinical trial design - Develop scalable analytical workflows to integrate genetics, omics, and clinical data sources - Work collaboratively with cross-functional teams including Discovery Biology, Clinical Development, Translational Medicine, and Data Science to support program decisions - Present results to internal stakeholders and contribute to reports, project discussions, and scientific publications - Manage multiple projects simultaneously and communicate progress and findings effectively to project teams and leadership - Adhere to data governance and compliance standards when working with sensitive clinical datasets Requirements - PhD in Biostatistics, Statistical Genetics, Epidemiology, Bioinformatics, Computational Biology, Biomedical Data Science, or a related quantitative discipline - 3+ years of experience in human genetics, biomedical data science, or real-world data analytics - Strong experience leveraging AI/LLMs to accelerate end-to-end research workflows, including coding, data analysis, literature synthesis, and report generation - Experience working with biobank-scale datasets and real-world data sources such as EHR, claims databases, registries, or population cohorts - Strong background in statistical genetics, epidemiology, or observational data analysis - Experience integrating genetics, omics, and clinical datasets - Proficiency in R or Python for large-scale data analysis - Excellent problem-solving, analytical, and communication skills - Ability to work effectively in a fast-paced, collaborative, and cross-functional research environment Preferred - Post-doc and industry experience - Experience analyzing large-scale population genetics datasets such as UK Biobank, FinnGen, All of Us, or Genomics England - Familiarity with analytical frameworks including phenome-wide association studies (PheWAS), Mendelian randomization, causal inference methods, and survival analysis - Experience working with real-world clinical data models such as OMOP / OHDSI - Experience collaborating with clinical development or real-world evidence teams - Experience applying machine learning or advanced statistical methods to biomedical datasets - Strong interest in translating human data into actionable insights for drug development Benefits - Competitive salary range: $145,000—$165,000 USD - Excellent benefits package - Candidates must have current, valid authorization to work in the country where this role is located

🏢 Summary: Sales Operations leadership role focused on supporting global automotive and trucking accounts through sales strategy, CRM analytics, RFI/RFQ coordination, and performance management. The position involves partnering with global account managers, leading sales operations teams, and driving data-driven sales improvements across international markets. 🗂️ Requirements: 8+ years of experience in automotive/trucking sales operations, Bachelor's degree, Expertise in automotive/trucking industries, Experience tracking sales metrics using CRM systems, Experience working with global teams, Experience supporting day-to-day sales personnel activities, Experience supporting Bid, RFI, and RFQ activities 📃 Skills: CRM, RFI, RFQ, Analytics, Dashboards, Reporting, Salesforce, Benchmarking 🏢 Description: We're ALTEN Technology USA, an engineering company helping clients bring groundbreaking ideas to life—from advancing space exploration and life-saving medical devices to building autonomous electric vehicles. With 3,000+ experts across North America, we partner with leading companies in aerospace, medical devices, robotics, automotive, commercial vehicles, EVs, rail, and more. As part of the global ALTEN Group—57,000+ engineers in 30 countries—we deliver across the entire product development cycle, from consulting to full project outsourcing. When you join ALTEN Technology USA, you'll collaborate on some of the world's toughest engineering challenges, supported by mentorship, career growth opportunities, and comprehensive benefits. We take pride in fostering a culture where employees feel valued, supported, and inspired to grow. Job Purpose: In collaboration with the Global Account Managers (GAM) and the Business Units, the Director Salesops and Performance (DSP) coordinates the Sales activity for dedicated market sector(s) and set of Global Customers in each geography to achieve annual sales ambitions in top line growth, market share and profitability. Main Duties & Responsibilities Market Strategy Support - Support analysis of Alten and its competitors' performance in designated market sectors - Propose insights based on benchmarks, historical data and understanding of market trends - Identify and escalate risks that would impact Alten business - Animate a global community to share market trends and provide actionable take aways - Provide on demand analysis of market sub-segment or Global customers - Periodically assess list of selected Global customers Commercial Support - Act as Business Partner to GAM for selected accounts - Interact with customers at senior level to support commercial activity, identify and address risk/opportunities - Coach Managers to animate internal/external commercial rituals for Global Accounts Sales Performance Management - Monitor sales momentum and pipeline health - Generate data-driven insights from CRM analytics to guide sales strategies - Create dashboards and reports to provide visibility into key sales performance metrics - Drive win/loss analysis and recommendations for continuous improvement of sales performance RFI/RFQ Management - Orchestrate RFI answer across geographies and Alten organizations in coordination with Bid team - Support large RFQ for selected accounts Sales Process and Tools - Contribute to streamline and improve efficiency of the end-to-end sales process and tools - Ensure central repository of documents and data to support sales activity Lead Sales Operations Team - Recruit, mentor or develop Sales Operations Managers and Analysts - Set goals for the team and manage workload - Guarantee high service level Qualifications: - 8+ yrs of experience in automotive/trucking sales operations position - Bachelor's degree required, Master's degree preferred - Expertise of automotive/trucking industries - Experience with tracking sales metrics on a CRM - Experience working with global teams - Experience driving and supporting day to day activities of sales personnel - Experience supporting Bid, RFI and RFQ activities Salary Range: 100,000-150,000 + Bonus The actual salary offered is dependent on various factors including, but not limited to, location, the candidate's combination of job-related knowledge, qualifications, skills, education, training, and experience. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age, genetic information, or pregnancy. Compliance Notice: Alten USA is a federal contractor subject to the requirements of the Vietnam Era Veterans' Readjustment Assistance Act (VEVRAA) and Executive Order 11246. We are an Equal Opportunity Employer and consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Drug Screening Requirement: As a federal contractor, Alten USA maintains a drug-free workplace. All candidates selected for employment will be required to successfully complete a pre-employment drug screening as a condition of hire.

🏢 Summary: Senior research finance leadership role focused on clinical trial budgeting, contracting, sponsor negotiations, and operational support across a global research network. The position manages budgeting and contract teams, oversees study startup financial processes, and collaborates with clinical, legal, and sponsor stakeholders. The role also drives process improvements, compliance, and financial performance for multi-site clinical research operations. 🗂️ Requirements: Bachelor's degree in Business, Finance, Healthcare Administration, Life Sciences, or related field, 7+ years of experience in clinical trial budgeting, contracting, research finance, or research administration, 3+ years of team management experience, Experience negotiating clinical trial budgets and contracts, Knowledge of clinical trial operations and study startup processes, Experience managing cross-functional stakeholder relationships, Strong analytical and negotiation skills, Strong organizational and communication skills 📃 Skills: Finance, Budgeting, Contracting, CLM, ClinicalResearch, Negotiation, Compliance, Analytics, SOPs, Procurement 🏢 Description: Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. We built a leading performance-driven network of 100+ sites across the US, Europe, India, and Australia, conducting research directly in the communities where care is delivered across gastrointestinal, hepatology, obesity, and cardiology. By combining deep clinical trial expertise with cutting-edge AI, we connect sponsors' scientific ambitions with high-performing research teams that expedite and expand access to novel therapeutics for patients in need. Today, Iterative Health is headquartered in Cambridge, Massachusetts, and New York City with 250+ employees world-wide. The Research Finance Manager is a senior leader at the intersection of finance, clinical operations, and sponsor partnerships. This role owns clinical trial budgeting, contracting, and financial performance across Iterative Health's global research network — overseeing a team of Budget Specialists while serving as the key escalation point for complex negotiations with sponsors, CROs, and research sites. The ideal candidate is a seasoned clinical research finance professional who brings sharp negotiation instincts, strong team leadership, and the operational rigor to keep study startup moving efficiently at scale. Where You'll Drive Impact Clinical Trial Budgeting & Contracting Manage the development, negotiation, and execution of clinical trial budgets, Clinical Trial Agreements (CTAs), amendments, and related study agreements across a global network of research sites. Serve as the primary escalation point for complex budget, contract, and study startup issues involving sponsors, CROs, research sites, and internal stakeholders. Develop and maintain standardized budgeting methodologies, negotiation tools, and country-specific rate cards. Prepare sponsor budget estimates, feasibility assessments, and pricing analyses to support new study opportunities and partnerships. Team Leadership & Development Manage and mentor Clinical Trial Budget Specialists and Contract Administrators responsible for study budgeting and contracting activities. Provide coaching, training, and performance management to ensure high-quality execution and professional development across the team. Lead regular team meetings and establish priorities to support organizational goals and study startup timelines. Develop educational programs and training materials related to budgeting, contracting, and negotiation best practices. Site Network & Operational Support Partner with Clinical Operations and site leadership to support study startup, activation metrics, and operational readiness. Participate in site selection discussions by evaluating financial feasibility, budget assumptions, and operational considerations. Support sponsor alliance management activities and participate in regular sponsor governance and project meetings. Collaborate with post-award teams to ensure accurate invoicing and adherence to contractual payment terms. Contract Administration Assist with contract lifecycle management (CLM) initiatives, including workflow improvements, document repository management, and process standardization. Coordinate with Legal and Procurement teams to support contract compliance and operational efficiency. Process Improvement & Compliance Develop and maintain SOPs, workflows, templates, and process documentation supporting budgeting and contracting activities. Track and report key performance indicators related to contract turnaround times, budget negotiations, and study startup milestones. Implement process improvements to enhance efficiency, consistency, and stakeholder satisfaction. Ensure compliance with organizational policies, contractual requirements, and applicable regulatory standards. Performs related duties as requested What You Bring to the Team Bachelor's degree in Business, Finance, Healthcare Administration, Life Sciences, or a related field. 7+ years of experience in clinical trial budgeting, contracting, clinical research finance, or related research administration, including at least 3 years managing a team. Proven experience negotiating clinical trial budgets and contracts with sponsors, CROs, and research sites. Working knowledge of clinical trial operations, study startup processes, and research financial management. Demonstrated ability to lead teams and manage cross-functional relationships across clinical, finance, and legal stakeholders. Strong analytical, negotiation, and communication skills. Exceptional attention to detail and organizational skills, with the ability to manage multiple priorities in a fast-paced environment. Preferred Qualifications Experience supporting global research programs across Europe and Asia. Familiarity with contract lifecycle management (CLM) systems and tools. Background in healthcare technology, biotech, or a multi-site clinical research network. How We Work Collaborative and low-ego team environment High ownership and accountability culture Fast-paced and highly iterative growth environment Open communication and continuous learning mindset Mission-driven organization focused on improving patient outcomes Comfortable navigating evolving business priorities and opportunities Benefits That Support You We believe great teams do their best work when they feel supported — professionally and personally. Hybrid work environment with in-office collaboration two days per week in either our NYC or Boston office Comprehensive medical, dental, and vision coverage, with up to 80% of premiums covered by Iterative Health Mental health and wellness support through Spring Health Health HSA or FSA options, and commuter FSA contributions supported by Iterative Health Unlimited PTO, 12 company holidays, and a company-wide shutdown between Christmas and New Years 401(k) program with a company match of up to 3% (up to $3,000 annually) Weekly in-office lunch benefit every Tuesday 100% company-paid short-term and long-term disability coverage Annual wellness and professional development stipend to support your health and growth And more! At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.

🏢 Summary: Senior Automotive Test Engineer role focused on defining and leading end-to-end test strategies for AI-driven automotive software systems, ensuring performance, reliability, and safety. The position owns validation architecture, test automation, and cross-functional coordination within complex vehicle environments. It emphasizes advanced testing tools, data-driven validation, and continuous process improvement. 🗂️ Requirements: Bachelor's degree in Computer Science or Electronics Engineering, 8+ years of automotive software testing experience, Hands-on experience with dSPACE, CANoe, CANape, DIVA, or OpenTest, Strong programming or scripting skills in JavaScript, Python, or CAPL, Experience in test automation and validation processes, Strong knowledge of test coverage analysis and defect tracking metrics, Experience working in cross-functional automotive engineering environments 📃 Skills: dSPACE, CANoe, CANape, DIVA, OpenTest, JavaScript, Python, CAPL, HIL, SIL, Automation, Validation, AI, Analytics, ISO, ISTQB, IREB 🏢 Description: We're ALTEN Technology USA, an engineering company helping clients bring groundbreaking ideas to life—from advancing space exploration and life-saving medical devices to building autonomous electric vehicles. With 3,000+ experts across North America, we partner with leading companies in aerospace, medical devices, robotics, automotive, commercial vehicles, EVs, rail, and more. As part of the global ALTEN Group—57,000+ engineers in 30 countries—we deliver across the entire product development cycle, from consulting to full project outsourcing. When you join ALTEN Technology USA, you'll collaborate on some of the world's toughest engineering challenges, supported by mentorship, career growth opportunities, and comprehensive benefits. We take pride in fostering a culture where employees feel valued, supported, and inspired to grow.Bachelor's degree in Computer Science or Electronics Engineering. Minimum 8+ years of experience in automotive software testing. This position is focused on defining and leading testing strategies for AI-driven automotive software systems, ensuring performance, reliability, and safety of advanced in-vehicle technologies. The role involves end-to-end validation strategy ownership, test architecture definition, and coordination of cross-functional testing activities within complex automotive environments. The engineer will work closely with development, validation, and system engineering teams to ensure robust test coverage, high-quality deliverables, and continuous improvement of testing processes. The position requires strong expertise in automotive testing environments, test automation, and validation frameworks, with a focus on intelligent vehicle systems. Key Responsibilities : Test Strategy & Architecture Define and lead end-to-end test strategies for AI-driven automotive software systems Design validation approaches to ensure performance, reliability, and safety of vehicle technologies Establish test coverage frameworks and ensure alignment with system requirements Drive continuous improvement of testing methodologies and validation processes Automotive Testing & Validation Tools Execute and oversee testing activities using industry-standard tools such as dSPACE, CANoe, CANape, DIVA, and OpenTest Support integration of hardware-in-the-loop (HIL) and software-in-the-loop (SIL) environments when applicable Ensure effective use of measurement and diagnostic tools for system validation Support end-to-end validation across automotive software development lifecycle Test Automation & Scripting Develop and maintain test automation scripts using JavaScript, Python, and CAPL Support automation of diagnostic and validation workflows Improve efficiency and repeatability of testing processes through scripting and tooling Collaborate with engineering teams to integrate automated testing into development pipelines Data & Analytics in Testing Support use of data pipelines and analytics tools for automotive software validation Analyze test data to identify trends, defects, and system performance issues Contribute to data-driven decision-making for validation and quality improvements Defect Management & Quality Improvement Track and analyze defects using structured metrics and reporting systems Support root cause analysis and resolution of complex technical issues Drive continuous improvement initiatives based on test results and quality indicators Cross-Functional Collaboration & Coordination Collaborate with software, system, and validation engineering teams Coordinate testing activities across multidisciplinary teams and stakeholders Clarify responsibilities and ensure alignment across testing and development efforts Build strong internal networks to support alignment and execution success Communication & Reporting Communicate test results, validation status, and technical findings clearly to stakeholders Prepare technical documentation, reports, and test summaries Present complex technical concepts in a clear and structured manner Support decision-making through accurate and timely reporting Profile : Experienced automotive test engineer with strong background in software testing and validation Comfortable working in complex, cross-functional, and safety-critical environments Strong analytical mindset with demonstrated problem-solving capabilities Self-driven, organized, and capable of managing multiple priorities effectively Strong communicator with ability to align stakeholders and drive collaboration Must Have : 8+ years of experience in automotive software testing Bachelor's degree in Computer Science or Electronics Engineering Hands-on experience with testing tools (dSPACE, CANoe, CANape, DIVA, OpenTest) Strong programming/scripting skills in JavaScript, Python, and/or CAPL Strong understanding of test coverage analysis and defect tracking metrics Experience working in cross-functional automotive environments Strong analytical, troubleshooting, and problem-solving skills Good communication and coordination abilities across teams Experience in test automation and validation processes Good to Have : ISTQB or IREB certification Experience with AI-driven or autonomous vehicle systems Knowledge of data pipelines and automotive analytics tools Experience with HIL/SIL environments Exposure to automotive safety or compliance standards (functional safety, ISO, etc.) Experience in large-scale OEM or Tier 1 automotive environments ALTEN Technology is an Equal Opportunity Employer. Our Policy is to extend opportunities to qualified applicants and employees on an equal basis regardless of an individual's age, race, color, sex, religion, national origin, disability, sexual orientation, gender identity/expression or veteran status. Please beware of job seeker scams and see this important notice on our careers page for more information about our recruiting process. Compliance Notice: Alten USA is a federal contractor subject to the requirements of the Vietnam Era Veterans' Readjustment Assistance Act (VEVRAA) and Executive Order 11246. We are an Equal Opportunity Employer and consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Drug Screening Requirement: As a federal contractor, Alten USA maintains a drug-free workplace. All candidates selected for employment will be required to successfully complete a pre-employment drug screening as a condition of hire.

🏢 Summary: Full-time onsite Associate Medical Director/Medical Director role focused on advancing RNAi-based cardiometabolic therapies from late-stage clinical research through regulatory submissions. The position involves leading clinical study design, safety monitoring, data interpretation, and cross-functional collaboration for cardiac, lipid, and obesity programs. 🗂️ Requirements: M.D. or MD/Ph.D., Research experience in pharmaceutical, biotechnology, or academic settings, Hands-on translational research experience, Understanding of drug development processes, Knowledge of Good Clinical Practices, Knowledge of FDA regulations and regulatory requirements, Ability to evaluate external scientific advice, Strong scientific and medical communication skills, Ability to work independently in a fast-paced team environment, Project management skills, Strong clinical, scientific, and technical skills, Valid work authorization in the country where the role is located 📃 Skills: RNAi, siRNA, GCP, FDA, NDA, MAA, IRB, Biometrics, ClinicalTrials, Regulatory, Pharmacology, Cardiology, Endocrinology 🏢 Description: Arrowhead Pharmaceuticals, Inc. is a commercial stage biopharmaceutical company focused on developing RNA interference (RNAi)-based therapies for genetically driven diseases. The Associate Medical Director/Medical Director will report to the head of cardiometabolic clinical development and will be instrumental in bringing new RNAi therapies to patients. This individual will collaborate with scientific and clinical teams to advance drugs from late-stage clinical research through NDA filings, with an initial focus on siRNA programs targeting cardiac and metabolic indications including lipids and obesity. This is a full-time onsite position based at the corporate headquarters in Pasadena, CA. Responsibilities - Support the conceptualization, design, development, execution, and communication of clinical studies across therapeutic areas - Act as a medical lead within cross-functional teams including medical, scientific, clinical, safety, program management, and regulatory staff - Communicate protocols and study information with clinical site investigators and staff - Interpret clinical trial data and communicate results accurately - Provide ongoing clinical monitoring including eligibility assessment, toxicity management, and drug safety surveillance - Contribute to IRB submissions, protocols, study reports, publications, and regulatory submissions including NDA/MAA filings - Provide scientific and clinical guidance to Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory, and Project Management teams - Identify key opinion leaders and participate in advisory board meetings - Deliver scientific presentations at advisory boards and scientific meetings - Identify and evaluate medical needs and new applications of RNA interference therapies - Monitor developments in RNA interference across industry and academia - Support licensing activities and partner relationships Requirements - M.D. or MD/Ph.D. with research experience - Hands-on translational research experience in pharmaceutical, biotechnology, or academic environments - Understanding of the drug development process - Knowledge of Good Clinical Practices, FDA regulations, and regulatory requirements - Ability to evaluate expert scientific advice - Strong written and verbal scientific communication skills - Ability to work independently in a fast-paced team environment - Strong clinical, scientific, and technical skills - Strong interpersonal and collaboration skills - Sense of urgency with problem-solving initiative - Project management skills and results-oriented mindset Preferred - Fellowship training in cardiology or endocrinology - Research focused on lipids or obesity Benefits - Competitive salary and benefits package - California pay range: $260,000–$310,000 USD - Candidates must have valid authorization to work in the country where the role is located.

🏢 Summary: Hybrid Data Analyst role focused on transforming and standardizing clinical study data into analysis-ready datasets, enabling cross-study consistency and reusability. The position involves data wrangling, anomaly detection, FAIR data improvements, and building reproducible workflows using Python, SQL, and AWS tools. The role requires close collaboration with stakeholders to translate ambiguous business questions into structured analytical outputs within a GDPR-compliant environment. 🗂️ Requirements: Proficiency in Python for data analysis and transformation, Proficiency in SQL for querying and validation, Experience with AWS environments including S3, Experience standardizing and harmonizing heterogeneous datasets, Ability to detect patterns, anomalies, and structural differences across datasets, Experience building reproducible data workflows, Experience with data visualization tools, Knowledge of GDPR-compliant data handling, Fluent English (spoken and written) 📃 Skills: Python, SQL, AWS, S3, PowerBI, GDPR, CDISC, SDTM, ADaM, SAS, MachineLearning, AI, LLM 🏢 Description: Data Analyst within Study Patient Operations About the project We are looking for a Data Analyst in collaboration with a global, science‑driven biopharmaceutical company that uses data and advanced analytics to accelerate the development of innovative therapies. As a Data Analyst in Study Patient Operations, you will transform diverse clinical study data into reliable, analysis‑ready datasets and support cross‑study standardisation and reusability. This role is ideal for someone who thrives in ambiguity, shows strong analytical curiosity, and proactively proposes structured solutions even with incomplete information. Work mode: hybrid — based in Warsaw, with one day per week on-site at the client’s office . Tasks Cross‑study data standardisation: Standardise and harmonise data from multiple studies with varying conventions to enable consistent cross‑study analysis. Pattern and anomaly detection: Identify patterns, discrepancies, anomalies, and structural differences across datasets and convert them into actionable mapping rules and validation checks. FAIR data improvement: Strengthen metadata, lineage, definitions, and data quality to enhance data accessibility and reusability, even when documentation is incomplete. Problem framing & stakeholder collaboration: Translate broad or ambiguous business questions into clear data requirements, analytical approaches, and defined pipeline outputs. Data wrangling & transformation: Extract, join, transform, and reconcile datasets using Python, SQL, and AWS‑based tools to support downstream analysis. Compliance, documentation & insight communication: Ensure GDPR‑aligned data handling, maintain audit‑ready documentation, and clearly communicate insights, limitations, and assumptions. Expectations Strong analytical problem‑solving skills in ambiguous contexts and ability to iterate toward clarity. Learning agility , with motivation to quickly understand new domains and clinical data standards. Standardisation mindset , with experience proposing consistent mappings across heterogeneous datasets. Pattern recognition ability across multiple datasets/studies. Proficiency in Python and SQL for analysis, validation, and reproducible workflows. Experience with AWS environments , especially S3 and analytical/querying tools. Data visualisation skills (Power BI or similar). Excellent communication and documentation abilities , especially explaining “what the data means.” Fluent in English (spoken and written) Beneficial Skills Familiarity with clinical trial standards (e.g., CDISC SDTM, ADaM ). Experience with SAS-formatted clinical datasets . Understanding of clinical study processes , privacy/consent principles, and patient data handling. Exposure to machine learning / AI / agentic tools . Interest or experience in LLM-based tooling , especially for metadata, documentation, or analytics workflows. We offer Ongoing support from a dedicated agent , taking care of your project continuity, client contact, necessary formalities, work comfort and development, Consultant Development Program – advice on growth planning based on the latest trends and market needs in IT, including consultations with agents and growth mentors, Access to 7N Learning & Development – a development and educational platform with webinars, a library of articles and industry reports, and regular invitations to one-time and recurring development events – technical, business, and lifestyle, Spectacular integration events , both for you (e.g., annual Kick-Off trip , Christmas parties, or Summer Olympics sports events) and for your loved ones (e.g., family picnics, movie premieres), Professional development not only during the project – you can get involved in knowledge transfer to others within the 7N Services offering directed at 7N clients, Relationships and access to the knowledge of the most experienced IT experts in the market – the average professional tenure of our consultants in Poland is over 10 years, A complete benefits package , including funding for medical care, life insurance, sports cards for you and your loved ones, as well as discounts in stores in Poland and abroad. About 7N Constantly searching for projects, difficult rate negotiations, lack of development support – sounds familiar? At 7N, you gain not only stability of contracts but also the personal involvement of a dedicated agent who ensures your professional comfort and continuous access to development initiatives. Our mission is to provide stable and rewarding collaborations that drive your success as an IT expert and the success of our clients. We build long-lasting relationships based on Scandinavian values and 30 years of experience creating IT solutions for over 200 organizations.

🏢 Summary: The role involves building and maintaining scalable automated testing solutions for CRM platforms and AI-driven components, combining TOSCA-based automation, functional testing, and AI validation. The engineer will design automation frameworks, execute regression tests, and ensure quality across global releases in an Agile environment. This position focuses on high-quality automation, AI testing practices, and continuous improvement within a mature engineering setup. 🗂️ Requirements: 4-6 years of hands-on experience in test automation, Experience with TOSCA and TOSCA Test Case Design, Ability to design and implement automation frameworks, Experience in functional and regression testing, Experience testing CRM applications, Knowledge of AI testing and prompt engineering, Experience working in Agile/Scrum environment, Familiarity with test management tools such as JIRA or Azure DevOps 📃 Skills: TOSCA, Automation, Testing, AI, CRM, JIRA, AzureDevOps, Agile, Scrum, Regression, PromptEngineering 🏢 Description: Tester AI / Automation Engineer (TOSCA) 📍 Location: Kraków (hybrid - 2 days in the office per week) 📄 B2B: 160–190 PLN /h We are looking for a Tester AI / Automation Engineer to join a global team responsible for building scalable, automated testing solutions for CRM platforms and AI‑driven components. The role combines test automation (TOSCA or similar) , functional testing , and AI testing , including prompt engineering and validation of AI‑based features. You will work in a mature engineering environment focused on automation, quality, and continuous improvement, collaborating with teams across multiple regions. Key Responsibilities: Design, develop and maintain automated test cases using TOSCA (or other automation tools). Create and execute functional and regression test scenarios. Build scalable, high‑quality automation components aligned with engineering best practices. Perform AI testing , including prompt engineering and validation of AI‑driven functionalities. Review business and system requirements, identifying defects early in the lifecycle. Estimate testing effort for new features and regression cycles. Manage defects, test environments, and testing metrics. Collaborate with global teams and ensure release governance is met. Identify process inefficiencies and propose pragmatic improvements. Requirements: 4-6 years of hands‑on experience in test automation (TOSCA preferred; certification is a plus). Ability to work across automation and functional testing . Experience designing and implementing automation frameworks. Strong knowledge of TOSCA Test Case Design (templates, RTBs, classes). Experience testing CRM applications and understanding CRM components. Exposure to Agile/Scrum delivery. Familiarity with test management tools such as JIRA or Azure DevOps . Nice to have: understanding of Investment Banking or Risk Management domains. What We Offer: Long‑term project in a global financial organization. Work with modern AI testing approaches and automation frameworks. Hybrid model - 2 days per week in the Kraków office. Mature engineering culture with strong focus on quality and automation. Private healthcare (Luxmed) and Multisport card. Why apply for an Antal job offer? When your application is successful, you will be supported by a dedicated Consultant who will stay in regular contact with you (via email or phone), help you prepare for interviews with your future employer, and ensure a smooth and professional recruitment process. About Antal Antal is a leading recruitment and HR advisory company, present in Poland since 1996 and later expanded to the Czech Republic and Hungary. Across the CEE region, we employ around 150 professionals who deliver a full range of services – from specialist and executive recruitment, employee outsourcing and HR consulting, to employer branding and market research. Our division-based structure combines deep industry expertise with functional specialisation, enabling us to provide tailored solutions for companies in every sector. We act as a trusted partner for both employers and candidates, sharing our knowledge and guiding them through every stage of the talent journey. We connect exceptional people with the right opportunities and help organisations build successful teams.