Associate Director, Regulatory Affairs (Global Regulatory Advertising and Promotion)

🏢 Summary: Senior Regulatory Affairs leadership role responsible for driving global labeling strategy and managing end-to-end regulatory labeling activities across development and post-approval phases. The position leads cross-functional collaboration, ensures compliance with global regulatory requirements, and oversees preparation, review, and maintenance of core and regional labeling documents. It also supports health authority interactions, policy development, and continuous improvement of labeling processes. 🗂️ Requirements: Bachelor's degree in life sciences, computer science, or related science discipline, Minimum 8+ years in biotech or pharmaceutical industry managing product labeling across at least two major geographic regions, Experience developing and maintaining global regulatory labeling throughout all development phases, Knowledge of FDA guidance documents and advertising promotion regulations, Experience negotiating with regulatory authorities and leading cross-functional discussions, Ability to review and ensure accuracy and compliance of regulatory labeling documents, Strong knowledge of MS Word formatting, PDF compliance, and validation tools, Valid work authorization in the country where the role is located 📃 Skills: Regulatory, Labeling, FDA, CCDS, USPI, SmPC, Veeva, RIM, AI, MSWord, PDF 🏢 Description: Arrowhead Pharmaceuticals, Inc. is a commercial stage biopharmaceutical company developing RNAi-based therapeutics designed to silence disease-causing genes. The company focuses on innovative treatments for genetically driven diseases, including programs targeting the liver and lung, supported by a broad RNA chemistry platform and advanced delivery technologies. The Position The Director of Regulatory Affairs serves as the company’s Labeling Lead, driving cross-functional development and execution of global regulatory labeling strategy. This role manages regulatory labeling across all phases of development and post-approval, ensuring compliance with current global requirements and standards. Responsibilities - Collaborate cross-functionally to develop labeling strategy and lead cross-functional labeling meetings. - Manage development, review, approval, and version control of labeling documents, including Target Product Labeling, Core Labeling (Company Core Data Sheet [CCDS]), and Regional Labeling (USPI, EU SmPC), in accordance with internal SOPs and external regulatory requirements. - Maintain expertise in global labeling requirements and guidelines, advising stakeholders on application of regulatory principles. - Research competitor and therapeutic class labeling to inform labeling text and negotiation strategies with regulatory authorities. - Perform proofreading and departmental quality control to ensure alignment of labeling text with data and regulatory standards. - Liaise with cross-functional stakeholders to resolve regulatory issues and implement labeling changes. - Partner with Clinical Regulatory teams to support labeling supplements, updates, and health authority interactions. - Ensure dissemination and controlled record maintenance of approved labeling documents and updates. - Build cross-functional partnerships to support strategic business goals. - Participate in continuous improvement initiatives for end-to-end labeling processes. - Monitor global regulatory environment and assess impact on labeling activities. - Facilitate policy development and updates with internal stakeholders. Requirements - Bachelor’s degree in life sciences, computer science, or related science discipline. - Minimum 8+ years in the biotech or pharmaceutical industry leading product labeling across two or more major geographic areas. - Knowledge of advertising promotion regulations and FDA guidance documents with technical understanding of drug development and labeling. - Experience leading cross-functional meetings and negotiating complex labeling issues with stakeholders and regulatory authorities. - Ability to review regulatory labeling documents for accuracy and compliance, identifying deviations and inconsistencies. - Strong knowledge of document formatting, including MS Word, PDF compliance, and validation tools. - High level of professionalism, integrity, and diplomacy. - Current, valid authorization to work in the country where the role is located. Preferred - Experience with regulatory information management systems (e.g., Veeva RIM, Registrations). - Knowledge of emerging technologies, including AI applications in regulatory operations. - Experience supporting global inspection readiness. Compensation and Benefits - California pay range: $210,000—$230,000 USD. - Competitive salary and excellent benefits package.

🏢 Summary: Director of Regulatory Affairs role responsible for leading global labeling strategy and execution across all development phases and post-approval activities. The position manages end-to-end regulatory labeling processes, collaborates cross-functionally, and ensures compliance with global regulatory requirements. It requires extensive experience in biotech/pharma labeling, health authority negotiations, and regulatory documentation management. 🗂️ Requirements: Bachelor's degree in life sciences, computer science, or related science discipline, Minimum 8+ years in biotech or pharmaceutical industry leading product labeling across at least two major geographic areas, Knowledge of advertising promotion regulations and FDA Guidance documents, Experience negotiating with regulatory authorities on complex labeling issues, Ability to review regulatory labeling documents for accuracy and regulatory compliance, Strong knowledge of document formatting and compliance tools (MS Word, PDF validation tools), Valid work authorization in the country where the role is located 📃 Skills: Regulatory, Labeling, FDA, CCDS, USPI, SmPC, Veeva, RIM, MSWord, PDF, AI 🏢 Description: Arrowhead Pharmaceuticals, Inc. is a commercial stage biopharmaceutical company developing RNAi-based therapies that silence genes responsible for intractable diseases. Using diverse RNA chemistries and delivery approaches, the company advances innovative treatments targeting genetically driven conditions across multiple therapeutic areas. The Position The Director of Regulatory Affairs serves as the Labeling Lead, driving cross-functional development and execution of global regulatory labeling strategy. This role manages regulatory labeling across all phases of development and post-approval, ensuring compliance with current regulatory standards and requirements. Responsibilities - Collaborate cross-functionally to develop labeling strategy and lead labeling meetings. - Manage development, review, approval, and version control of labeling documents, including Target Product Labeling, Core Labeling (e.g., Company Core Data Sheet [CCDS]), and Regional Labeling (e.g., USPI, EU SmPC), in accordance with internal SOPs and regulatory requirements. - Maintain expertise in labeling regulations and advise stakeholders on application of labeling principles. - Research competitor and therapeutic class labeling to guide labeling text and negotiation strategies. - Perform proofreading and quality control to ensure alignment with data and regulatory standards. - Liaise with stakeholders to resolve regulatory issues and implement labeling changes. - Support labeling supplements, updates, and health authority interactions. - Ensure dissemination and controlled documentation of approved labeling. - Build partnerships to support strategic business goals. - Participate in continuous improvement of labeling processes. - Monitor global regulatory environment and assess impact on labeling activities. - Facilitate policy development and updates. Requirements - Bachelor's degree in life sciences, computer science, or related science discipline. - Minimum 8+ years in biotech or pharmaceutical industry leading product labeling across two or more major geographic areas. - Knowledge of advertising promotion regulations and FDA Guidance documents with technical experience in drug development and labeling. - Experience leading cross-functional meetings and negotiating with regulatory authorities. - Ability to review labeling documents for regulatory accuracy and consistency. - Strong knowledge of MS Word document formatting, PDF compliance, and validation tools. - High degree of professionalism, integrity, and diplomacy. - Valid authorization to work in the country where the role is located. Preferred - Experience with regulatory information management systems (e.g., Veeva RIM, Registrations). - Knowledge of emerging technologies, including AI applications in regulatory operations. - Experience supporting global inspection readiness. Arrowhead provides competitive salaries and an excellent benefits package.

🏢 Summary: The Information Security Systems Analyst is responsible for administering and optimizing Microsoft Purview to ensure effective data governance, data loss prevention, and information protection within a regulated environment. The role focuses on managing sensitivity labels, DLP policies, eDiscovery, and insider risk management while supporting broader Microsoft 365 security operations. It involves monitoring compliance, investigating alerts, and collaborating with cross-functional teams to protect sensitive and regulated data. 🗂️ Requirements: Bachelor's degree in Information Security, Information Technology, Computer Science or related field or equivalent experience, 3+ years of experience in Information Security, IT compliance, or data governance, Hands-on experience administering Microsoft Purview or Microsoft 365 Compliance Center, Experience with at least two of the following: sensitivity labels, DLP, retention policies, eDiscovery, Insider Risk Management, Experience working in a regulated industry environment, Ability to investigate security alerts and interpret audit logs, Valid work authorization in the country of employment 📃 Skills: MicrosoftPurview, Microsoft365, DLP, eDiscovery, InsiderRiskManagement, Intune, Exchange, SharePoint, OneDrive, Teams, AuditLogs, SIEM, EDR, IAM, MCAS 🏢 Description: The Information Security Systems Analyst is responsible for the day-to-day administration, operation, and continuous improvement of the organization's Microsoft Purview platform, serving as the primary subject matter expert for data governance, data loss prevention (DLP), and information protection. This role operates at the intersection of information security, data governance, and regulatory compliance, ensuring that sensitive data - including intellectual property, clinical trial data, and personally identifiable information - is properly classified, protected, and governed in accordance with applicable regulations and internal policies. In addition to Purview-focused responsibilities, this analyst contributes to broader information security operations including troubleshooting endpoints, working in Microsoft 365, and Intune. Responsibilities The analyst will serve as the hands-on operational owner of Microsoft Purview, managing the platform on a daily basis across its core functional areas: Information Protection & Data Classification - Administer and maintain Microsoft Purview sensitivity labels, label policies, and auto-labeling configurations - Develop and refine classification taxonomies appropriate to pharmaceutical data types, including research data, regulatory submissions, and patient data - Review and tune auto-classification rules to minimize false positives and ensure accurate labeling across Microsoft 365 and connected data sources Data Loss Prevention - Build, maintain, and continuously tune DLP policies across Exchange, SharePoint, OneDrive, Teams, and endpoints - Investigate DLP policy matches and alerts, differentiate true policy violations from false positives, and refine rules without disrupting legitimate workflows - Document DLP incidents and escalate confirmed violations per the incident response process E-Discovery & Content Search - Support legal hold requests and eDiscovery collections - Work with Legal and HR to scope, execute, and export content searches in accordance with chain-of-custody requirements Insider Risk Management - Administer Purview Insider Risk Management policies and review alerts - Coordinate with HR, Legal, and Security leadership on confirmed or suspected insider risk cases - Maintain strict confidentiality in handling insider risk data Audit & Reporting - Generate and interpret Purview audit logs, compliance reports, and dashboard analytics - Provide regular reporting on DLP incidents, label adoption rates, policy effectiveness, and compliance posture - Identify trends and recommend adjustments to policies and configurations Platform Administration & Health Monitoring - Monitor the health and performance of the Purview platform - Apply configuration changes and updates in alignment with change management processes - Manage connector integrations with third-party data sources - Maintain clear documentation including runbooks, diagrams, standards, and exceptions - Triage security alerts and escalate as necessary Requirements - Bachelor's degree in Information Security, Information Technology, Computer Science, or related field, or equivalent practical experience - 3+ years of experience in Information Security, IT compliance, or data governance - Demonstrated hands-on experience administering Microsoft Purview or Microsoft 365 Compliance Center, including at least two of the following: sensitivity labels, DLP, retention policies, eDiscovery, or Insider Risk Management - Experience working within or supporting a regulated industry environment - Strong analytical and problem-solving skills - Effective written and verbal communication skills - Current, valid authorization to work in the country where this role is located Preferred - Microsoft certifications relevant to security and compliance such as SC-401 - Experience with Microsoft Defender for Cloud Apps (MCAS) - Experience supporting eDiscovery or legal hold workflows - Exposure to SIEM tools, endpoint detection and response (EDR) platforms, or identity and access management systems Compensation Wisconsin pay range $85,000—$100,000 USD California pay range $95,000—$110,000 USD Arrowhead provides competitive salaries and an excellent benefit package.

🏢 Summary: The Information Security Systems Analyst leads the administration and optimization of Microsoft Purview to enforce data governance, DLP, and information protection across Microsoft 365. The role supports eDiscovery, Insider Risk Management, audit reporting, and broader security operations in a regulated environment. This position ensures sensitive data is properly classified, protected, and compliant with internal policies and external regulations. 🗂️ Requirements: Bachelor's degree in Information Security, Information Technology, Computer Science, or related field (or equivalent experience), 3+ years of experience in Information Security, IT compliance, or data governance, Hands-on experience administering Microsoft Purview or Microsoft 365 Compliance Center, Experience with at least two: sensitivity labels, DLP, retention policies, eDiscovery, Insider Risk Management, Experience supporting a regulated industry environment, Ability to investigate alerts and interpret audit logs, Authorization to work in the country where the role is located 📃 Skills: Microsoft, Purview, Microsoft365, DLP, eDiscovery, InsiderRisk, Intune, Exchange, SharePoint, OneDrive, Teams, Defender, MCAS, SIEM, EDR, IAM 🏢 Description: The Position The Information Security Systems Analyst is responsible for the day-to-day administration, operation, and continuous improvement of the organization's Microsoft Purview platform, serving as the primary subject matter expert for data governance, data loss prevention (DLP), and information protection. This role operates at the intersection of information security, data governance, and regulatory compliance, ensuring that sensitive data - including intellectual property, clinical trial data, and personally identifiable information - is properly classified, protected, and governed in accordance with applicable regulations and internal policies. In addition to Purview-focused responsibilities, this analyst contributes to broader information security operations including troubleshooting endpoints, working in Microsoft 365, and Intune. Responsibilities Information Protection & Data Classification - Administer and maintain Microsoft Purview sensitivity labels, label policies, and auto-labeling configurations. Develop and refine classification taxonomies appropriate to pharmaceutical data types, including research data, regulatory submissions, and patient data. Review and tune auto-classification rules to minimize false positives and ensure accurate labeling across Microsoft 365 and connected data sources. Data Loss Prevention - Build, maintain, and continuously tune DLP policies across Exchange, SharePoint, OneDrive, Teams, and endpoints. Investigate DLP policy matches and alerts, differentiate true policy violations from false positives, and work with business stakeholders to refine rules without disrupting legitimate business workflows. Document DLP incidents and escalate confirmed violations per the incident response process. eDiscovery & Content Search - Support legal hold requests and eDiscovery collections. Work with Legal and HR to scope, execute, and export content searches accurately and in accordance with chain-of-custody requirements. Insider Risk Management - Administer Purview Insider Risk Management policies, review alerts, and coordinate with HR, Legal, and Security leadership on confirmed or suspected insider risk cases. Maintain strict confidentiality in handling all insider risk data. Audit & Reporting - Generate and interpret Purview audit logs, compliance reports, and dashboard analytics. Provide regular reporting to management on DLP incidents, label adoption rates, policy effectiveness, and compliance posture. Identify trends and recommend adjustments to policies and configurations. Platform Administration & Health Monitoring - Monitor the health and performance of the Purview platform, apply configuration changes and updates in alignment with change management processes, and stay current on Microsoft feature releases relevant to Purview. Manage connector integrations with third-party data sources as required. Maintain clear documentation (runbooks, diagrams, standards, exceptions) and contribute to a knowledge base. Triage security alerts and escalate as necessary. Requirements Bachelor's degree in Information Security, Information Technology, Computer Science, or a related field, or equivalent practical experience 3+ years of experience in Information Security, IT compliance, or data governance role Demonstrated hands-on experience administering Microsoft Purview or Microsoft 365 Compliance Center, including at least two of the following areas: sensitivity labels, DLP, retention policies, eDiscovery, or Insider Risk Management Experience working within or supporting a regulated industry environment Strong analytical and problem-solving skills with the ability to investigate alerts, interpret audit logs, and distinguish signal from noise Effective written and verbal communication skills, with the ability to explain technical concepts to non-technical stakeholders Preferred Microsoft certifications relevant to security and compliance, such as SC-401 Experience with Microsoft Defender for Cloud Apps (MCAS) and its integration with Purview Prior experience in the pharmaceutical, biotech, or life sciences sector Experience supporting eDiscovery or legal hold workflows in collaboration with Legal teams Exposure to SIEM tools, endpoint detection and response (EDR) platforms, or identity and access management systems Comfortable working across functional teams including Legal, Compliance, HR, and IT, and possesses the judgment to handle sensitive data and insider risk information with appropriate discretion. Compensation & Benefits Wisconsin pay range $85,000—$100,000 USD California pay range $95,000—$110,000 USD Competitive salary and excellent benefit package Candidates must have current, valid authorization to work in the country where this role is located.

🏢 Summary: Newly created Revenue Accounting Manager role responsible for full ownership of revenue recognition processes, including partnership and commercial revenue, in a life sciences environment. The position serves as the ASC 606 subject‑matter expert, leading complex contract assessments, month‑end close, SOX compliance, and revenue disclosures. This is a high‑impact role requiring strong technical accounting expertise and cross‑functional collaboration. 🗂️ Requirements: Bachelor's degree in Accounting, Finance, or related field, 5+ years financial accounting experience, Significant experience with revenue recognition (ASC 606), In‑depth knowledge of U.S. GAAP, Experience with SOX compliance requirements, Experience managing monthly and quarterly close processes, Ability to assess complex contracts and determine revenue treatment, Strong cross‑functional communication skills, Ability to manage complex, multi‑phase projects, Work authorization in the country of employment 📃 Skills: ASC606, GAAP, SOX, Accounting, Revenue, FP&A, JournalEntries, Reconciliations, SECReporting, OrderToCash 🏢 Description: The Position Arrowhead is seeking a Revenue Accounting Manager to join its Finance & Accounting team. Reporting to the Senior Accounting Manager and working closely with the Controller, this role will manage all aspects of partnership/collaboration accounting and commercial revenue. This is a newly created, high-impact role designed to build and scale revenue recognition processes in a complex life sciences environment. The Revenue Accounting Manager will own the company’s revenue framework and serve as the subject-matter expert for ASC 606 revenue accounting, ensuring accurate financial reporting, operational efficiency, and SOX compliance. Responsibilities Develop a deep understanding of partnership and customer contracts and serve as the subject-matter expert on revenue accounting under ASC 606 and U.S. GAAP. Review and assess complex contracts, including partnership arrangements, to determine appropriate revenue recognition treatment and disclosure requirements. Establish and maintain revenue accounting policies and procedures in accordance with regulatory standards and SOX control requirements. Partner with FP&A to lead cross-functional efforts to ensure accurate tracking of actual labor hours and facilitate updates to budgeted resource assumptions. Ensure inputs to input-method revenue recognition are accurate, well-supported, and audit-ready. Perform order-to-cash month-end and quarter-end close activities, including preparation and posting of journal entries, balance sheet reconciliations, and flux analysis. Assist with gross-to-net revenue accounting, including reviewing third-party support and month-end close activities. Lead the preparation of revenue-related disclosures for the Company’s Forms 10-Q and 10-K. Prepare and maintain SOX-compliant controls for the revenue and accounts receivable cycles, ensuring proper execution and documentation. Requirements Bachelor's degree in Accounting, Finance, or a related field. 5+ years of financial accounting experience, with significant focus on revenue recognition (ASC 606). In-depth knowledge of U.S. GAAP and SOX compliance requirements as they apply to revenue recognition, receivables, contract assets, and deferred revenue. Demonstrated ability to manage and execute complex monthly and quarterly close processes. Strong ability to communicate complex accounting guidance to non-finance and cross-functional partners. Strong organizational skills with attention to detail and ability to meet tight timelines. Ability to adapt to a rapidly changing environment and occasional travel between company locations. Preferred Experience in a technical accounting role within life sciences, biotech, or pharmaceutical industry. Big 4 accounting firm experience. Public company experience. Compensation and Benefits California pay range: $120,000–$145,000 USD. Competitive salary and comprehensive benefits package. Candidates must have current, valid authorization to work in the country where this role is located.

🏢 Summary: Newly created Revenue Accounting Manager role responsible for full ownership of revenue recognition processes, including partnership and commercial revenue, under ASC 606 in a life sciences environment. The position leads complex contract assessments, month‑end close activities, SOX-compliant controls, and revenue disclosures, while partnering cross‑functionally to ensure accurate financial reporting. This is a high-impact, in-office role requiring strong technical accounting expertise and experience in biotech or pharmaceutical settings. 🗂️ Requirements: Bachelor's degree in Accounting, Finance, or related field, 5+ years of financial accounting experience with strong focus on ASC 606 revenue recognition, In-depth knowledge of U.S. GAAP, Experience with SOX compliance requirements, Experience managing complex monthly and quarterly close processes, Ability to assess complex contracts and determine revenue recognition treatment, Experience preparing revenue-related disclosures (10-Q, 10-K), Authorization to work in the country of employment 📃 Skills: ASC606, GAAP, SOX, RevenueRecognition, FinancialReporting, JournalEntries, Reconciliations, OrderToCash, GrossToNet, SECReporting 🏢 Description: The Position Arrowhead is seeking a Revenue Accounting Manager to join its Finance & Accounting team at its Pasadena, CA headquarters. Reporting to the Senior Accounting Manager and working closely with the Controller, the Revenue Accounting Manager will manage all aspects of partnership/collaboration accounting and commercial revenue. This is a newly created, high-impact role designed to build and scale best-in-class revenue recognition processes in the life sciences industry, where revenue models are complex and highly specialized. The role carries full ownership of the company's revenue framework and serves as the subject-matter expert for ASC 606 revenue accounting. Success in this position requires a strong mix of technical accounting expertise, leadership, and cross-functional collaboration to ensure accurate financial reporting, operational efficiency, and SOX compliance. The ideal candidate is detail-driven, highly responsive, tech-savvy, and adaptable in a fast-moving environment, with 5+ years of progressive experience in finance or accounting, with a significant focus on revenue recognition (ASC 606), preferably within biotech or pharmaceutical companies. This role is based in Pasadena or San Diego, CA with an expectation to be in office 5 days a week. Responsibilities Develop a deep understanding of partnership and customer contracts and serve as the subject-matter expert on revenue accounting under ASC 606 and U.S. GAAP. Review and assess complex contracts, including partnership arrangements, to determine appropriate revenue recognition treatment and disclosure requirements. Establish and maintain revenue accounting policies and procedures in accordance with regulatory standards and SOX control requirements. Partner with FP&A to lead cross-functional efforts to ensure accurate tracking of actual labor hours and facilitate updates to budgeted resource assumptions. Ensure inputs to input-method revenue recognition are well-supported, accurate, and audit-ready. Perform order-to-cash month-end and quarter-end close activities, including the preparation and posting of journal entries, completion of balance sheet reconciliations and flux analysis. Assist with gross-to-net revenue accounting, including reviewing support provided by third parties and month-end close activities. Lead the preparation of revenue-related disclosures for the Company's Forms 10-Q and 10-K. Prepare and maintain SOX-compliant controls for the revenue and accounts receivable cycles, ensuring proper execution and documentation. Requirements Bachelor's degree in Accounting, Finance, or a related field. 5+ years of financial accounting experience, with a significant focus on revenue recognition (ASC 606). In-depth knowledge of U.S. GAAP and SOX compliance requirements as they apply to revenue recognition, receivables, contract assets and deferred revenue. Demonstrated ability to manage and execute complex monthly and quarterly close processes. Demonstrated ability to communicate complex accounting guidance clearly and effectively to non-finance and cross-functional partners. Strong capability to lead change initiatives and successfully manage complex, multi-phase projects. Strong organizational skills, with a focus on accuracy, detail orientation and the ability to produce in tight timelines. Strong interpersonal, oral and written communication skills. Possess the highest level of integrity. Ability to adapt to a rapidly changing environment. Excellent team player. Self-motivated with an insatiable desire to learn and be challenged. Ability for occasional travel between locations. Preferred Demonstrated experience in a technical accounting role within the life sciences, biotech, or pharmaceutical industry. Big 4 accounting firm experience. Public company experience. California pay range $120,000—$145,000 USD. Arrowhead provides competitive salaries and an excellent benefit package. Candidates must have current, valid authorization to work in the country where this role is located. California Applicant Privacy Policy.

🏢 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: 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: 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: 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