Sr. Manager/ Associate Director, Biostatistics

🏢 Summary: The Senior Manager / Associate Director, Statistical Programming leads and oversees statistical programming activities across clinical development programs, ensuring high-quality, regulatory-compliant deliverables for trials and submissions. The role drives strategy, vendor oversight, CDISC standards implementation, and cross-functional collaboration while mentoring programming teams. It offers significant impact on regulatory submissions, data standards, and biometrics process innovation. 🗂️ Requirements: Master’s degree in Statistics, Biostatistics, Mathematics, Computer Science, or related quantitative field (or Bachelor’s with significant relevant experience), 7+ years (Senior Manager) or 9+ years (Associate Director) statistical programming experience in biotech, pharma, or CRO, Experience as lead programmer supporting clinical development programs and regulatory submissions, Advanced proficiency in SAS programming (Base, Stat, Graph, Macro, SQL), Extensive experience with CDISC standards (SDTM, ADaM, Define.xml), Strong knowledge of ICH, GCP, FDA, EMA regulatory requirements, Experience managing CROs, FSPs, or external programming vendors 📃 Skills: SAS, BaseSAS, SASStat, SASGraph, SASMacro, SQL, R, CDISC, SDTM, ADaM, Define.xml, Pinnacle21, ICH, GCP, FDA, EMA 🏢 Description: Position Summary: The Senior Manager / Associate Director, Statistical Programming will provide strategic and operational leadership for statistical programming activities across one or more clinical development programs. This individual will be responsible for the planning, execution, oversight, and delivery of statistical programming outputs supporting clinical trials, regulatory submissions, publications, and internal decision-making. The successful candidate will serve as a key partner to Biostatistics, Clinical Data Management, Clinical Operations, Medical, Medical Affairs, Regulatory Affairs, Pharmacovigilance, and external vendors to ensure high-quality, compliant, and timely programming deliverables. This role offers the opportunity to influence programming standards, mentor team members, and contribute to the continued growth of the Biometrics organization. Essential Duties and Responsibilities: Statistical Programming Leadership Lead statistical programming activities for one or more clinical studies, programs, or therapeutic areas. Provide strategic oversight and accountability for the development, validation, and delivery of statistical programming outputs, including SDTM and ADaM data packages (SDRG, ADRG, Define.xml, submission-ready datasets), and Tables, Listings, Figures (TLFs). Ensure programming deliverables meet quality, timeline, regulatory, and audit-readiness requirements. Support regulatory submissions, health authority interactions, publications, and ad hoc analyses. Vendor and CRO Oversight Manage and oversee outsourced statistical programming activities conducted by CROs and external partners. Review and validate datasets, TLFs, specifications, and programming documentation generated by vendors. Monitor vendor performance, timelines, quality metrics, and resource allocation to ensure successful project execution. Establish and maintain effective partnerships with external programming and biometrics vendors. Cross-Functional Collaboration Partner closely with Biostatistics, Data Management, Clinical Operations, Medical, Medical Affairs, Regulatory Affairs, Pharmacovigilance, and other stakeholders to deliver high-quality clinical data and analyses. Review and provide programming input on Protocols, Statistical Analysis Plans (SAPs), Data Management Plans (DMPs), CRFs, annotated CRFs, data review plans, and dataset and TLF specifications. Collaborate on the development of data review tools, dashboards, visualizations, and other statistical applications to support clinical development activities. Communicate programming strategies, timelines, risks, and resource needs to project teams and leadership. Standards, Innovation, and Process Improvement Contribute to the development, implementation, and continuous improvement of internal statistical programming standards, processes, and best practices. Assist with establishing framework of programming environment, including library of macros. Drive adoption of CDISC standards, programming automation, and innovative analytical solutions. Maintain expertise in regulatory requirements, industry standards, and emerging technologies related to statistical programming. Support inspection readiness and represent Statistical Programming during audits and regulatory inspections as needed. Team Leadership and Development Mentor, coach, and develop junior statistical programmers to support individual growth and organizational success. Provide leadership and technical guidance to internal and external programming teams. Participate in recruiting, onboarding, and developing programming talent. Foster an inclusive, collaborative, and psychologically safe environment that encourages innovation, learning, and accountability. Required Education and Experience: Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related quantitative discipline. Bachelor's degree with significant relevant experience will also be considered. Sr Manager: 7+ years of statistical programming experience within the biotechnology, pharmaceutical, or CRO industry; Associate Director: 9+ years of experience. Demonstrated experience serving as a lead programmer supporting clinical development programs and regulatory submissions. Advanced proficiency in SAS programming, including Base SAS, Stat, Graph, Macro, SQL, and generation of submission-ready deliverables. Working knowledge of R or other modern statistical programming languages is a plus. Experience with producing publication-quality statistical graphics using SAS/R is a plus. Experience with building/contributing to global SAS macro library for TFL generation is highly desirable. Extensive experience with CDISC standards, including SDTM, ADaM, Define.xml, controlled terminology, and regulatory submission requirements. Experience with Pinnacle 21 is a plus. Strong understanding of ICH guidelines, GCP, FDA, EMA, and other global regulatory requirements. Experience managing external CROs, FSPs, or programming vendors. Excellent project management, organizational, communication, and stakeholder management skills. Preferred Experience supporting multiple clinical programs from early development through regulatory submission. Experience implementing programming standards, automation initiatives, or modern analytics platforms.

🏢 Summary: Leadership role overseeing clinical data management across development programs, ensuring high-quality, compliant clinical trial data from study start-up through database lock and regulatory submission. The position drives data strategy, database design, vendor oversight, PK data review, and cross-functional collaboration to support successful clinical and regulatory outcomes. Strong focus on regulatory compliance, inspection readiness, and industry data standards. 🗂️ Requirements: BS/BA in bioscience, engineering, computer science, medical or related field, 6+ years (MS) or 9+ years (BS) clinical data management experience for Senior Manager, 9+ years (MS) or 12+ years (BS) clinical data management experience for Associate Director, Experience leading data management from study start-up through database lock, Strong vendor and CRO oversight experience, Experience supporting regulatory submissions and inspection readiness, Knowledge of ICH-GCP and FDA regulations, Experience with EDC systems (e.g., Medidata Rave) 📃 Skills: EDC, Medidata, Rave, CDISC, CDASH, SDTM, MedDRA, WHODrug, ICH-GCP, FDA, 21CFRPart11, PK, UAT, SOP, GCDMP 🏢 Description: Position Summary: Senior Manager / Associate Director, Clinical Data Management to provide leadership and oversight of clinical data management activities across one or more development programs. This individual is responsible for ensuring the quality, integrity, timeliness, and regulatory compliance of clinical trial data from study start-up through database lock and submission readiness. Working closely with Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Clinical Pharmacology, Pharmacovigilance, Regulatory Affairs, Information Technology, and external partners, this role serves as the Data Management lead for assigned studies and programs, driving data strategy, vendor oversight, process excellence, and inspection readiness. Essential Duties and Responsibilities: Clinical Data Management Leadership - Lead clinical data management activities for assigned studies (especially PK trials) from protocol development through database lock and submission readiness. - Serve as primary point of contact for CROs and vendors, ensuring data delivery on time, within budget, and in compliance with ICH-GCP guidelines. - Represent Data Management on cross-functional study teams, aligning deliverables with study objectives, timelines, and regulatory requirements. - Develop and execute study-specific data management strategies to ensure high-quality, analyzable clinical trial data. - Oversee and maintain Data Management Plans (DMPs), data review plans, and study-level documentation. Database Design, Build, and Validation - Collaborate on design and review of electronic Case Report Forms (eCRFs). - Develop and review database build specifications, edit check specifications, CRF completion guidelines, and validation plans. - Lead User Acceptance Testing (UAT) and oversee database go-live readiness. - Ensure databases are designed and validated in accordance with protocol requirements, CDASH standards, and best practices. Data Review and Quality Oversight - Lead ongoing PK and clinical data review, discrepancy management, query generation, and resolution. - Establish and monitor data quality metrics to ensure accuracy, consistency, completeness, and analysis readiness. - Oversee reconciliation activities including SAEs, laboratory data, medical coding, protocol deviations, and external data sources. - Manage MedDRA and WHODrug coding activities. - Support database lock activities and final data transfers for statistical analysis and regulatory submissions. Vendor and CRO Management - Manage bioanalytical vendors for PK assays and ensure appropriate data collection. - Provide oversight of CROs, EDC providers, specialty laboratories, and other external vendors. - Participate in vendor selection, RFP reviews, and vendor assessments. - Review vendor contracts, data transfer agreements, and service deliverables. - Monitor vendor performance, timelines, quality metrics, and issue resolution. Cross-Functional Collaboration - Partner with Biostatistics and Statistical Programming to support data review, SAP development, listings review, and submission readiness. - Collaborate with Clinical Operations, Clinical Pharmacology, Safety, Regulatory Affairs, and Medical teams to ensure accurate data collection and reporting. - Provide data management updates, risk assessments, and recommendations in study team meetings. - Support preparation and review of clinical study reports, tables, listings, and regulatory submission deliverables. Process Improvement and Compliance - Contribute to development and continuous improvement of Data Management processes, SOPs, standards, and best practices. - Ensure compliance with ICH-GCP, FDA regulations, CDISC/CDASH standards, GCDMP guidelines, and company procedures. - Support inspection readiness and participate in regulatory inspections and audits. - Mentor junior team members and contribute to team development. Required Education and Experience: - BS/BA in bioscience, engineering, computer science, medical training, or related field; MS/MA preferred. - Senior Manager: 6+ years (MS/MA) or 9+ years (BS/BA) of clinical data management experience in biotechnology, pharmaceutical, or CRO industry. - Associate Director: 9+ years (MS/MA) or 12+ years (BS/BA) of clinical data management experience in biotechnology, pharmaceutical, or CRO industry. - Experience leading data management from study start-up through database lock. - Strong vendor and CRO oversight experience. - Experience supporting regulatory submissions and inspection readiness. Preferred: - Management of PK trial data and clinical pharmacology experience. Additional Skills, Knowledge, and Abilities: - Deep understanding of clinical data management principles and industry standards. - Working knowledge of ICH-GCP, FDA regulations, 21 CFR Part 11, CDISC/CDASH, SDTM, MedDRA, and WHODrug. - Experience with EDC systems such as Medidata Rave or equivalent. - Experience with drug development and PK sample collection. - Strong understanding of external data integrations, reconciliation processes, and database lock procedures. - Strong project management, organizational, and problem-solving skills. - Ability to manage multiple priorities in a fast-paced environment.

🏢 Summary: The Director Clinical Data Management leads and oversees all clinical data management activities across multiple clinical trials, ensuring high-quality, inspection-ready data to support regulatory submissions and business objectives. This role sets data strategy, manages CROs and vendors, and drives risk-based quality and process excellence across Phase I–III programs. The position collaborates cross-functionally to deliver compliant data aligned with global regulatory standards. 🗂️ Requirements: BS/BA in Life Sciences, Engineering, Computer Science, Mathematics, Statistics or related field, 12+ years (MS) or 15+ years (BS) in clinical data management in biotech, pharma, or CRO, 5+ years of people management experience, Experience supporting Phase I–III clinical trials, Experience overseeing CROs and external data management vendors, Strong knowledge of CDISC standards, Strong knowledge of GCP and ICH Guidelines, Strong knowledge of FDA and global regulatory requirements, Experience with modern EDC systems (Medidata Rave, Veeva CDMS, Oracle or equivalent), Experience with risk-based quality management (RBQM) 📃 Skills: CDISC, GCP, ICH, FDA, EDC, Medidata, Rave, Veeva, Oracle, RBQM 🏢 Description: Position Summary: The Director Clinical Data Management provides strategic and operational leadership for all clinical data management activities across the clinical development portfolio. This individual serves as the functional leader for Data Management, responsible for establishing data strategy, overseeing external partners, driving process excellence, and ensuring the delivery of high-quality, inspection-ready clinical data that supports clinical development, regulatory submissions, and business objectives. Essential Duties and Responsibilities: Lead and oversee all clinical data management activities across multiple clinical studies and development programs. Develop and implement data management strategies that support clinical, regulatory, and business objectives. Provide leadership and oversight of CROs and technology vendors responsible for data management deliverables. Ensure quality, integrity, consistency, and timely availability of clinical trial data. Collaborate closely with Biostatistics, Statistical Programming, Clinical Operations, Clinical Development, Medical Monitoring, Regulatory Affairs, and Pharmacovigilance teams. Review and approve key study documentation including: Data Management Plans Edit Check Specifications CRF Design Data Review Plans Database Build and Validation Documentation Drive risk-based data review and quality management practices. Support regulatory inspections and audits. Contribute to submission readiness activities including NDA, BLA, MAA, and other global regulatory filings. Build scalable data management processes, standards, and SOPs as the organization grows. Mentor and develop internal team members and consultants. Required Education and Experience: BS/BA degree in Life Sciences, Engineering, Computer Science, Mathematics, Statistics, or related field; MS/MA degree preferred. 12+ (if MS/MA degree) or 15+ (if BS/BA degree) years of clinical data management experience within biotechnology, pharmaceutical, CRO, or related environments. 5+ years of people management experience. Demonstrated experience supporting Phase I–III clinical trials. Experience overseeing external data management vendors and CRO partnerships. Strong understanding of: CDISC standards GCP ICH Guidelines FDA and global regulatory requirements Experience with modern EDC systems such as Medidata Rave, Veeva CDMS, Oracle, or equivalent platforms. Additional Skills, Knowledge, Abilities: Experience with risk-based quality management (RBQM).

🏢 Summary: Senior commercial leadership role responsible for architecting and executing global and U.S. launch strategy for a lead biologic candidate in Hidradenitis Suppurativa. The position drives brand strategy, launch readiness, market access, and cross-functional alignment to ensure successful first product commercialization. This role combines strategic vision with hands-on execution in a fast-paced biotechnology environment. 🗂️ Requirements: Bachelor’s degree, 12+ years biotechnology, pharmaceutical, or healthcare industry experience, 5+ years leading launch planning or commercial operations, Experience leading at least one major pharmaceutical or biotechnology product launch, Experience managing cross-functional initiatives in a matrixed environment 📃 Skills: Commercialization, Launch, Forecasting, CompetitiveIntelligence, MarketAccess, HEOR, Regulatory, Biologics, Immunology, Dermatology, Pricing, Contracting, KPIs 🏢 Description: Position Summary: This individual will serve as the commercial architect for Avalo's first potential product launch. The successful candidate will be responsible for developing and executing global and U.S. launch readiness plans, shaping brand strategy, generating deep customer insights, building commercial capabilities, and partnering cross-functionally to maximize the value of the HS franchise. This highly visible leadership role requires a strategic thinker who can operate effectively in a fast-paced biotechnology environment while balancing long-term commercial vision with hands-on execution. The individual will work closely with Clinical Development, Medical Affairs, Market Access, Regulatory Affairs, Investor Relations, Business Development, and external partners to position Avalo for a successful commercialization and growth trajectory. Essential Duties and Responsibilities: Commercial Strategy & Brand Leadership Advance and lead the overall commercial strategy for abdakibart, Avalo's lead drug candidate, in Hidradenitis Suppurativa (HS). Build the brand vision, positioning, messaging, value proposition, and lifecycle strategy. Direct market assessment, forecasting, competitive intelligence, and commercial planning activities. Translate clinical and scientific data into differentiated customer-focused strategies. Identify market opportunities, risks, and competitive dynamics to inform business decisions. Serve as the commercial lead on cross-functional program teams. Manage external agency partners. Launch Excellence Build and execute comprehensive cross-functional launch readiness plans. Establish launch milestones, KPIs, governance structures, and performance tracking mechanisms. Lead pre-launch customer engagement and market shaping initiatives. Ensure organizational readiness across marketing, sales, market access, patient services, and operations. Develop launch scenarios and contingency plans to support evolving clinical and regulatory timelines. Customer Insights & Market Development Generate actionable insights from healthcare providers, patients, payers, advocacy groups, and key opinion leaders. Develop customer segmentation and targeting strategies. Establish strong relationships with external experts, advocacy organizations and HS stakeholders. Market Access & Value Strategy Partner closely with Market Access to develop payer, reimbursement, and value communication strategies. Support pricing, contracting, and access planning efforts. Ensure commercial strategies are aligned with payer expectations and patient access objectives. Cross-Functional Leadership Collaborate closely with Clinical Development and operations, HEOR, Medical Affairs, Regulatory Affairs, Manufacturing, and Supply Chain to ensure commercial perspectives are integrated throughout development. Partner with Medical Affairs to optimize scientific communication plans and publication strategies. Support investor and board communications regarding the commercial opportunity for abdakibart in HS and launch readiness plans. Represent commercial perspectives in governance and strategic planning discussions. Required Education and Experience: Bachelor's degree required; advanced degree (MBA, MPH, PharmD, MS, or PhD) preferred. 12+ years of biotechnology, pharmaceutical, or healthcare industry experience. 5+ years leading launch planning, launch excellence, commercial operations, new product planning, or strategic program management. Demonstrated success leading at least one major pharmaceutical or biotechnology product launch. Experience coordinating complex, cross-functional initiatives in a matrixed environment. Experience in dermatology and/or immunology/inflammation specialty products, preferred. Preferred Qualifications Experience launching biologics or specialty therapies. Understanding of HS, dermatology, immunology, or inflammatory disease markets. Experience within emerging biotechnology companies and first-launch organizations. Familiarity with global launch planning and commercialization frameworks.

🏢 Summary: The Bioinformatics Scientist role supports NIH research by independently designing and implementing advanced computational analyses for high-dimensional omics data. The position focuses on statistical genomics, machine learning, and multi-omics integration to generate biologically meaningful insights. The scientist develops scalable pipelines, custom software, and reproducible workflows while collaborating with interdisciplinary research teams. 🗂️ Requirements: Ph.D. in Bioinformatics, Computational Biology, Genomics, Data Science, Biostatistics, Computer Science, Biomedical Engineering or related quantitative field (Master’s with relevant experience acceptable), Minimum three years of relevant research experience, Experience in machine learning or advanced statistical modeling for high-dimensional biological data, Expertise in next-generation sequencing data analysis, Experience with multi-omics data integration, Proficiency in programming for bioinformatics analysis, Experience developing and maintaining analytical pipelines, Ability to work with large-scale datasets, Experience establishing reproducible workflows and documentation practices 📃 Skills: R, Python, MATLAB, Linux, Unix, Java, Shell, Perl, Bash, SAS, Git, Docker, Singularity, Apptainer, HPC, RNA-Seq, ChIP-Seq, miRNA-Seq, GWAS, Microarray, MachineLearning, DeepLearning, Multiomics, Statistics, Genomics, Transcriptomics, Epigenomics, Proteomics, DataVisualization, WorkflowManagement, Cloud 🏢 Description: Axle is seeking a Bioinformatics Scientist to support research activities at the National Institutes of Health (NIH) in Research Triangle Park, NC. Benefits We Offer: - 100% Medical, Dental & Vision Coverage for Employees - Paid Time Off and Paid Holidays - 401K match up to 5% - Educational Benefits for Career Growth - Employee Referral Bonus - Flexible Spending Accounts: - Healthcare (FSA) - Parking Reimbursement Account (PRK) - Dependent Care Assistant Program (DCAP) - Transportation Reimbursement Account (TRN) Position Information: This position independently provides bioinformatics and data science support to advance the institute's operational and research objectives. The role requires expertise in statistical genomics, machine learning, and scalable analysis and integration of high-dimensional omics data, applying AI-driven methods to generate biologically meaningful insights. Additional Qualifications: - Ph.D. preferred (or Master's) in Bioinformatics, Computational Biology, Genomics, Data Science, Biostatistics, Computer Science, Biomedical Engineering, or a closely related quantitative field - Three years of experience in a relevant discipline - Demonstrated training or experience in machine learning, artificial intelligence, or advanced statistical modeling applied to high-dimensional biological data Software: - R - Python - MATLAB - Linux - Unix - Java - Shell - PERL - Bash - SAS - HPC - Git - Docker / Singularity / Apptainer - Workflow management tools Core Technical Areas: - Next-generation sequencing data analysis (Bulk RNA-Sequencing, Single Cell RNA-Sequencing) - Genome-wide association studies - Microarray data analysis - Multi-omics analysis and integration - Pipeline development - Machine learning and deep learning - Representation learning for omics data - Cloud platforms - Reproducible research practices - Data visualization Deliverables and Responsibilities: - Design analytical strategies and resolve scientific or technical challenges - Analyze and interpret high-throughput biological data - Develop and maintain custom analytical software, scripts, and computational pipelines - Establish reproducible workflows and standard operating procedures (SOPs) - Optimize analytical pipelines for multi-omics datasets - Perform preprocessing, quality control, integration, clustering, and differential expression analysis of single-cell datasets - Conduct analyses on NextGen sequencing data including ChIP-Seq, RNA-Seq, miRNA-Seq and related platforms - Perform genomic platform analysis including expression, exon, tiling, and promoter arrays - Apply machine learning approaches to integrate large-scale, complex multi-omic data - Develop computational infrastructure resources for large and complex datasets - Provide statistical support and devise novel analytical methods - Prepare scientific reports, publication-quality figures, and manuscripts - Present findings at meetings, seminars, and conferences - Train staff and provide technical support for bioinformatics tools and pipelines - Collaborate with interdisciplinary teams to design experiments and interpret results - Maintain detailed documentation and reproducible data analysis practices

🏢 Summary: Full-time Allergist/Immunologist Physician role focused on diagnosing and managing allergic, asthma, and immunologic conditions in a patient-centered, multidisciplinary setting. The position combines comprehensive clinical care with active involvement in clinical research and trials. Opportunity to contribute to innovative immunotherapy and biologic treatments while shaping care delivery in a growing practice. 🗂️ Requirements: MD or DO degree from accredited medical school, Completed residency in Internal Medicine or Pediatrics, Completed fellowship in Allergy and Immunology, Board certified or board eligible in Allergy and Immunology (ABAI), Valid and unrestricted California medical license, Experience diagnosing and managing allergies, asthma, and immunologic conditions, Hands-on experience with allergy testing, spirometry, and immunotherapy administration 📃 Skills: Immunotherapy, Spirometry, AllergyTesting, PulmonaryFunctionTesting, ClinicalResearch, ClinicalTrials, DataAnalysis, Biologics, OralImmunotherapy, SublingualImmunotherapy, EMR 🏢 Description: About 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. Position Summary We are seeking a highly skilled and compassionate Allergist/Immunologist Physician to join our growing practice at our Alhambra and Hacienda Heights location. 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. 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). - Start allergy immunotherapy for environmental allergies and oral immunotherapy for food allergy. - Recommend food or drug challenges as part of allergy evaluation. - Collaborate with other specialists to ensure comprehensive patient care. - Maintain accurate and up-to-date medical records in compliance with healthcare regulations. - Participate in continuing medical education (CME). - Ensure high patient satisfaction and provide empathetic, patient-centered care. Research Responsibilities - Engage in clinical research initiatives related to the diagnosis, treatment, and prevention of allergic and immunologic diseases. - Participate in designing and conducting clinical trials on new therapies, biologic treatments, and immunotherapy options. - Analyze data, prepare research reports, and collaborate with research teams to publish findings. - Contribute to the development of innovative clinical pathways and treatment strategies based on research findings. - Work with industry partners, academic institutions, and research foundations to advance clinical studies. - Provide mentorship to junior researchers. - Present research findings at national and international conferences. 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; highly qualified new fellowship graduates considered. - Demonstrated experience diagnosing and managing 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. 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. - Interest in innovative treatments and advancement of immunology. Compensation The annual salary range for this position in California is $130,000–250,000 per year. Actual compensation will be determined based on skills, education, and experience. Physical Requirements Ability to stand, walk, and move throughout the clinic for extended periods; occasionally lift up to 25 lbs.; bend, stoop, or reach as needed. Frequent use of hands and fingers for patient care and equipment operation. Normal (or corrected) vision and hearing required. What We Offer - Competitive salary and benefits package, including medical, dental, and vision insurance. - 401(k) retirement plan with employer matching. - Professional development opportunities. - Paid time off (PTO), sick time, floating holiday, and holiday pay. - Supportive, mission-focused culture with opportunities to impact patient outcomes and practice growth.

🏢 Summary: Full-time Prior Authorization (Buy and Bill) Specialist role in a clinic setting, responsible for managing insurance verifications, prior authorizations, medication scheduling, and inventory processes to ensure timely reimbursement and compliance. The position supports injection and medication workflows, monitors billing outcomes, and collaborates across clinics to streamline operations. Ideal for candidates with healthcare billing experience and strong knowledge of buy-and-bill procedures in a fast-paced medical environment. 🗂️ Requirements: 2+ years experience in healthcare administration, medical billing, or inventory management, Experience with buy-and-bill medication processes, Knowledge of insurance prior authorizations and reimbursement policies, Understanding of HIPAA and Medicare/Medicaid guidelines, Proficiency in medical software systems, Proficiency in inventory management tools, Proficiency in Microsoft Office Suite 📃 Skills: EHR, Billing, Buy-and-Bill, HIPAA, Medicare, Medicaid, Microsoft, Inventory, Authorization 🏢 Description: About 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 detail-oriented and proactive Prior Authorization (Buy and Bill) Specialist to join our clinic team. In this role, you will handle scheduling, inventory management, and authorization processes, while collaborating on innovative tech solutions and supporting site expansions along the Prior Authorization Manager and/or Practice Manager. This position requires strong organizational skills, knowledge of healthcare billing practices (Buy & Bill), and the ability to work in a fast-paced medical environment. This is a full-time, non-exempt (hourly) position, scheduled for 40 hours per week. Work hours may vary based on assigned clinic location, Monday through Friday. This role will be based primarily in our Sorrento Valley clinic but may also provide support to other nearby locations within San Diego County. The ideal candidate is adaptable and enjoys collaborating across multiple sites to ensure seamless operations and excellent patient experiences. Key Responsibilities Call insurance companies to verify coverage (PPO and HMO), obtain benefit details, and confirm authorization requirements. Submit, track, and manage prior authorizations in a timely manner, ensuring documentation meets payer and clinical requirements. Coordinate with clinics and Practice Managers to align on injection and medication timelines, patient scheduling, and clinical administration. Schedule appointments and times for patients to receive their medications, coordinating with clinical staff to ensure timely and appropriate administration. Track medication inventory levels, monitor stock to prevent shortages, and initiate purchasing orders as needed to maintain adequate supplies. Monitor reimbursement and billing success rates, analyze denials or discrepancies, and collaborate with billing teams to resolve issues and improve collection processes. Implement checks to prevent patients from receiving medications too early, adhering to prescribed intervals and regulatory guidelines. Verify that all necessary authorizations are in place prior to medication administration, minimizing risks of non-reimbursement or compliance violations. A Typical Day May Include Calling payers, submitting new and renewal prior authorizations, and following up to ensure timely approvals. Updating patient notes and EHR records to reflect authorization status and next steps. Coordinating with clinics and patients to manage scheduling, follow-ups, and re-authorizations. Communicating with pharmacies to confirm shipments and ensure medications are delivered on time. Monitoring injection timelines to prevent care delays and authorization lapses. Qualifications & Requirements Education: Bachelor's degree in healthcare administration, business, or related field preferred Experience: 2+ years of experience in healthcare administration, medical billing, or inventory management, with familiarity in buy-and-bill processes for medications. Relevant certifications (e.g., Certified Medical Assistant or Billing Specialist) preferred. Medical or medical assistant background strongly preferred. Strong understanding of insurance prior authorizations, reimbursement policies, and healthcare compliance regulations (e.g., HIPAA, Medicare/Medicaid guidelines). Proficiency in medical software systems, inventory management tools, and Microsoft Office Suite; experience with automation or tech integration projects is a plus Skills & Abilities: Excellent organizational and multitasking skills, with the ability to prioritize tasks in a dynamic environment. Strong communication and negotiation abilities for working with vendors, tech partners, insurers, and internal teams. Attention to detail and problem-solving mindset to handle complex billing and authorization scenarios. Ability to work independently and collaboratively in a team-oriented settings. Compensation The hourly range for this position is $22.00-30.00/hour. The actual compensation for this role will be determined by a variety of factors, including but not limited to the candidate's skills, education, and experience.Physical Requirements Ability to stand, walk, and move throughout the clinic, if applicable, for extended periods; occasionally lift objects up to 25 lbs., bend, stoop, or reach as needed. Frequent use of hands and fingers for patient care and equipment operation. Must have normal (or corrected) vision and hearing and be able to respond quickly in a fast-paced clinical environment, if applicable. What We Offer 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) A supportive, mission-focused culture where your contributions directly impact patient outcomes and team growth If this role excites you, please submit your resume and a cover letter outlining your relevant experience and why you're passionate about joining our team. We look forward to hearing from enthusiastic candidates ready to drive our success! California Consumer Privacy Act (CCPA) NoticeModena 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.

🏢 Summary: Full-time Allergist/Immunologist Physician role focused on diagnosing and managing allergic, asthma, and immunologic conditions in a patient-centered clinical environment, with opportunities to engage in clinical research and trials. The position combines comprehensive outpatient care, advanced immunotherapy procedures, and collaboration with multidisciplinary teams. This is a salaried Monday–Friday role with minimal travel and involvement in innovative treatment and research initiatives. 🗂️ Requirements: MD or DO degree from accredited medical school, Completed residency in Internal Medicine or Pediatrics, Completed fellowship in Allergy and Immunology, Board certified or board eligible in Allergy and Immunology (ABAI), Valid and unrestricted California medical license, Hands-on experience in allergy testing, spirometry, and immunotherapy administration, Ability to diagnose and manage allergies, asthma, and immunologic conditions 📃 Skills: Allergy, Immunology, Spirometry, Immunotherapy, Biologics, ClinicalResearch, ClinicalTrials, DataAnalysis, SkinTesting, PulmonaryFunctionTesting 🏢 Description: About the Role We are seeking a highly skilled and compassionate Allergist/Immunologist Physician to join a growing practice in Riverside County. This is a full-time, exempt (salary) position 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). Start allergy immunotherapy for environmental allergies. Start oral immunotherapy for food allergy. Recommend food or drug challenges as part of allergy evaluation. Collaborate with other specialists (e.g., pulmonologists, dermatologists, primary care physicians) to ensure comprehensive care. 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, patient-centered care. Additional duties as assigned. Research Responsibilities Engage in clinical research initiatives related to the diagnosis, treatment, and prevention of allergic and immunologic diseases. 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 with industry partners, academic institutions, and research foundations to advance clinical studies in allergy and immunology. Provide mentorship and guidance to junior researchers. 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; highly qualified new fellowship graduates considered. Demonstrated experience diagnosing and managing 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. 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. Interest in innovative treatments and advancing immunology. Compensation Annual salary range in California: $130,000–$250,000 per year. Compensation is based on skills, education, and experience. Physical Requirements Ability to stand, walk, and move throughout the clinic for extended periods; occasionally lift up to 25 lbs.; bend, stoop, or reach as needed. Frequent use of hands and fingers for patient care and equipment operation. Normal (or corrected) vision and hearing required and ability to respond quickly in a fast-paced clinical environment. What We Offer Competitive salary and benefits package including medical, dental, and vision insurance. 401(k) retirement plan with employer matching. Professional development opportunities. Paid time off (PTO), sick time, floating holiday, and holiday pay. Supportive, mission-focused culture with opportunity to impact patient outcomes and practice growth.

🏢 Summary: Full-time Medical Assistant I role in an allergy and immunotherapy clinic, supporting patient care, pulmonary testing, and immunotherapy treatments across multiple locations. The position focuses on administering injections, conducting diagnostic tests, documenting in EHR systems, and ensuring compliance with clinical standards. Ideal for candidates with clinical experience seeking to grow in a fast-paced specialty environment. 🗂️ Requirements: High school diploma or GED, 1–3 years of experience as a Medical Assistant in a clinical setting, Active Medical Assistant certification in California, CPR certification or willingness to obtain, Ability to administer immunotherapy injections, Ability to perform pulmonary function testing, Experience with EHR systems, Knowledge of HIPAA and OSHA compliance standards 📃 Skills: EHR, Immunotherapy, Injections, PulmonaryFunctionTesting, PFT, FeNO, PeakFlow, SkinTesting, PatchTesting, VitalSigns, HIPAA, OSHA, CPR, Sterilization, PriorAuthorizations 🏢 Description: Position Summary We are seeking a compassionate and detail-oriented Medical Assistant I to join our allergy and immunotherapy team. This clinical role is ideal for candidates with a strong interest in patient care and a desire to grow in a fast-paced specialty clinic. You will play a critical role in supporting patient treatment, ensuring safety, and maintaining a clean, organized clinical environment. This role is non-exempt (hourly) and full-time, working 40 hours per week, Monday through Friday. This role will be based primarily in our El Centro clinic but may also provide support to other nearby locations within San Diego County. The ideal candidate is adaptable and enjoys collaborating across multiple sites to ensure seamless operations and excellent patient experiences. Key Responsibilities Patient Care & Clinical Support: - Greet patients and assist with intake and preparation for provider visits - Provide general care and administer prescribed treatments, including allergy/immunotherapy injections - Educate patients and families on immunotherapy protocols and safety - Monitor and document vital signs, treatment responses, and observation periods post-injection Procedures & Testing: - Assist with skin testing, patch testing, and pulmonary function testing - Calibrate and operate PFT equipment (Pulmonary Function Testing) - Support clinical team during peak times and complex procedures Clinical Operations & Documentation: - Maintain clean, stocked exam and injection rooms - Document patient vitals, test results, and care summaries in the EHR - Perform routine equipment sterilization and ensure compliance with HIPAA and OSHA standards - Support limited submission of prior authorizations (PAs) when requested Team Collaboration: - Assist LVNs or RNs during procedures as needed - Function as part of the immunotherapy nursing team, administering injections per protocols - Perform other clinical or administrative duties as assigned by supervisors or providers - Additional duties as assigned Qualifications & Requirements Education: - High school diploma or GED (minimum requirement) Experience: - 1–3 years of experience as a Medical Assistant in a clinical setting - Experience with EHR systems preferred - Experience in allergy or immunology preferred but not required Licensure & Certifications: - Active MA certification in the state of California - CPR certification required (or willingness to obtain) Skills & Abilities: - Strong communication and organizational skills - Comfortable working independently and exercising sound judgment - Skilled in pulmonary function testing, FeNO testing, and peak flow monitoring - Knowledge of patient education for medications and environmental controls Compensation The hourly range for this position is $23.00–28.00/hour. The actual compensation for this role will be determined by a variety of factors, including but not limited to the candidate's skills, education, and experience. Physical Requirements Ability to stand, walk, and move throughout the clinic for extended periods; occasionally lift objects up to 25 lbs., bend, stoop, or reach as needed. Frequent use of hands and fingers for patient care and equipment operation. Must have normal (or corrected) vision and hearing and be able to respond quickly in a fast-paced clinical environment. What We Offer - Competitive salary and benefits package, including medical, dental & vision insurance, 401(k) retirement plan with employer matching, and professional development opportunities - Paid time off (PTO), sick time, floating holiday, and holiday pay - Opportunity to shape the future of a thriving allergy and asthma practice - A supportive, mission-focused culture where your contributions directly impact patient outcomes and team growth

🏢 Summary: The role focuses on ensuring GxP‑regulated digital systems, particularly LIMS and connected laboratory platforms, remain validated, compliant, and fit for purpose throughout their lifecycle. It combines hands‑on CSV validation, data integrity oversight, and system integration control with product ownership and stakeholder collaboration in Agile/DevOps environments. The position supports global validation, user adoption, and continuous improvement of regulated laboratory systems. 🗂️ Requirements: Bachelor’s or Master’s degree in Computer Science, Engineering or related field, Minimum 5 years of experience in product specialist or validation roles, Strong experience with GxP / CSV validation of laboratory or scientific software, Hands-on experience with ValGenesis and/or Azure DevOps, Knowledge of software development lifecycle in Agile/DevOps environments, Experience with validation lifecycle activities (IQ, OQ, PQ), Understanding of data integrity principles (ALCOA+), Experience validating system integrations and interfaces, Knowledge of role-based access control and electronic records/signatures compliance 📃 Skills: GxP, CSV, LIMS, SDMS, SAP, ValGenesis, Azure, DevOps, ALCOA+, IQ, OQ, PQ, ERP, Agile, RBAC 🏢 Description: At Bayer, we are committed to transparency, equal pay for equal work or work of equal value, and objective reward practices in line with EU and local regulations. The minimum annual gross compensation for this role is 20 240 PLN , with final pay determined based on objective factors such as experience, qualifications, scope of responsibility, and internal alignment. This position is eligible for variable pay components , such as performance‑based bonuses, awarded in accordance with the applicable employee group, role scope, and compensation structure. In addition, Bayer offers a competitive and holistic benefits package, including: - Medical care above statutory requirements - Flexible benefits supporting leisure, and well‑being/sports programs - Life, accident, and disability insurance through group coverage - Employer‑supported pension plans with regular company contributions - Home office allowance to support hybrid or remote work - Extra Paid Holidays Benefits may vary depending on country, role, and employment conditions. For Digital Hub Warsaw, we are looking for: Senior Product Specialist: As a Senior Product Specialist, you will ensure regulated digital products remain compliant, validated, and user-friendly throughout their lifecycle. You will combine GxP validation expertise, product enablement, and stakeholder collaboration to deliver high-quality solutions, particularly across LIMS and connected laboratory systems. YOUR TASKS AND RESPONSIBILITIES Validation & Compliance Lead GxP validation activities across the full system lifecycle (implementation → decommissioning). Plan and oversee IQ/OQ/PQ, ensuring systems remain in a validated state in Agile/DevOps environments. Manage validation deliverables (plans, risk assessments, testing, deviations, change control). Ensure data integrity (ALCOA+), audit trails, e-signatures, and access controls. Validate integrations with LIMS, SDMS, instruments, and ERP/SAP. Act as SME for validation and compliance topics . Product Adoption & Collaboration Drive user adoption through training, communication, and documentation. Align stakeholders across business, quality, and engineering. Coordinate UAT, acceptance criteria, and release readiness. Translate technical and compliance topics for diverse audiences. Use feedback and metrics to improve product performance and user experience . Leadership & Delivery Lead cross-functional initiatives and validation workstreams. Manage timelines, risks, and dependencies. Support continuous improvement and mentor junior team members. WHO YOU ARE: Required Qualifications Bachelor’s or Master’s degree in Computer Science, Engineering, Life Sciences, or related field. 5–7+ years of experience in product specialization, validation, or similar roles in regulated environments. Strong hands-on experience in GxP / CSV validation of scientific or laboratory software. Proven experience with validation tools such as ValGenesis and/or Azure DevOps. Strong understanding of software development lifecycle (SDLC) and Agile/DevOps methodologies. Demonstrated ability to lead cross-functional initiatives and manage complex projects. Excellent communication, stakeholder management, and influencing skills. Preferred Qualifications Experience with LIMS, SDMS, or SAP in regulated laboratory environments. Exposure to product development, backlog management, or product ownership concepts. Formal project management experience or certification. Experience working in global, multi-regional, or multi-platform environments. Ability to influence without formal authority and navigate complex stakeholder landscapes Please send your CV in English.