Ionis Pharmaceuticals

Title: Ioniverse (Data & AI) Platform Owner / Enterprise Solutions Architect Job Category: R&D Support - Ionis Requisition Number: IONIS004049 Full-Time Locations 2855 Gazelle Ct HQ USA Carlsbad, CA 92010, USA Boston, MA 02108, USA Job Description: Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We’re pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals. At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees. With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive. We’re building on our rich history, and we believe our greatest achievements are ahead of us. If you’re passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career! Director, Enterprise Data & AI Platform SUMMARY: Reporting to the VP, Data & Analytics, the Ioniverse (Data & AI) Platform Owner / Enterprise Solutions Architect will serve as the senior technical leader responsible for operationalizing the Ioniverse as an enterprise-scale data and AI platform centered on Databricks and modern cloud engineering practices. This role owns the platform roadmap, technical direction, architecture standards, and delivery guardrails for the Ioniverse. It establishes reusable engineering patterns and governance controls, enables teams across enterprise domains, and helps move trusted data and AI solutions into production safely, quickly, and consistently. Location: preference is onsite/hybrid but willing to consider remote What Success Looks Like: • Ionis has a clear, enforced, modular, and future-ready architecture for data and AI solutions on the Ioniverse. • Teams move data and AI solutions from sandbox to production faster with less reinvention, stronger controls, and more consistent delivery practices. • Trusted data, semantic assets, and solution patterns are discoverable, governed, and reusable, powering AI-driven insights, automation, and business workflows across the enterprise. • Governance and platform standards support both speed and compliance while reducing fragmentation and strengthening internal capability across enterprise domains. RESPONSIBILITIES: • Own the Ioniverse platform roadmap, technical direction, and architecture standards for enterprise data and AI solutions, with Databricks as the core platform foundation. • Define and implement target-state patterns for data pipelines, semantic access, AI enablement, observability, security, and production support. • Lead the design, automation, optimization, and operational support of data engineering environments across development, test, and production. • Establish onboarding standards, guardrails, and promotion paths that move domain data products from sandbox experimentation to certified, trusted production use. • Define and enforce standards for data quality, metadata, lineage, certification, stewardship, access control, and reuse in partnership with governance, privacy, compliance, and security stakeholders. • Build reusable accelerators, templates, reference architectures, playbooks, and shared platform services that improve delivery speed, consistency, scalability and maintainability across teams. • Implement DevOps best practices for CI/CD, monitoring, cost optimization, and MLOps to support advanced analytics and AI initiatives in production. • Partner with BRPs, portfolio leads, domain product owners, data stewards, and technical teams to align priorities, intake, definitions, service levels, and certification expectations. • Assess tools, vendors, and partner recommendations with a bias toward leveraging Ionis investments, reducing fragmentation, and strengthening long-term internal capability. • Partner across data engineering, data science, AI engineering, data intelligence, and business teams to accelerate delivery of priority data and AI solutions into trusted production use. • Define interoperable data, workflow, and semantic patterns that enable consistent adoption across Commercial, Research, Development, Finance, and other enterprise domains. • Experience leading consulting or partner teams and delivering business value in Agile, iterative environments. • Ensure solution patterns incorporate appropriate security, role-based access, lifecycle controls, fit-for-purpose AI and analytics delivery patterns, and sound cloud cost management. • Lead consulting and vendor partners while serving as a hands-on platform leader who prototypes, troubleshoots, and helps implement the architecture and patterns they define. REQUIREMENTS: • Significant experience in data platform, data engineering, analytics engineering, AI/ML platform, or architecture roles with hands-on delivery responsibility. • Strong experience with Databricks and cloud-based data platforms in enterprise production environments. • Proven ability to design and implement production-grade data, analytics, automation, and AI solutions. • Experience with cloud architecture, pipeline design, data engineering, DevOps, and production support. • Experience defining standards for data quality, metadata, lineage, governance, access control, and lifecycle management. • Strong SQL and Python skills, with the ability to work directly with engineers and technical platform teams. • Ability to translate business priorities into practical architecture, roadmaps, engineering standards, and execution decisions. • Strong judgment in architecture trade-offs, build-versus-buy decisions, and vendor evaluation. • Experience in life sciences or another regulated industry, including enterprise data governance, cross-functional data product design, and platform operating models. • Familiarity with Unity Catalog, MLflow, semantic layers, AI-assisted analytics, and enterprise systems spanning SAP, CRM, ERP, Commercial, and Clinical domains. • 15 years of related experience with a bachelor’s degree or 12 years and a master’s degree. The pay scale for this position is $159,053-$268,000

• Interact within assigned accounts to support patient access, providing proactive face-to-face (or virtual if appropriate) education on programs to providers and staff to support integration of those programs into office processes and workflows. • Leverage data and analytical tools to address customer questions for issues related to payer policies and access requirements . • Work with key members of customer accounts (e.g., providers, administrators, billing and coding staff, etc.) to appropriately support patient access. • Address customer questions related to payer policies (e.g., utilization management, denial, and appeals) and patient reimbursement. • Collaborate with aligned cross-functional partners (identified above) to share insights on customer needs and barriers related to access and reimbursement. • Maintain a deep understanding of Ionis policies and requirements and perform all responsibilities with integrity and in a manner consistent with company guidance and prescribed Values and Behaviors. • Handle Patient Identifiable Information (PII) appropriately (understand and ensure compliance with HIPAA and other privacy laws and regulations and internal Company compliance policies/guidelines). • Responsible for identifying and reporting adverse events via the established Ionis systems as per applicable processes.

• Responsible for the launch of Ionis’s first wholly owned commercial product • Drive performance and work with cross-functional partners and external customers. • Build, maintain, and leverage networks and relationships in the local healthcare system. • Educate HCPs on sHTG disease state awareness and treatment urgency. • Execute brand strategic plans by developing customer focused territory strategic account plans. • Participate in field meetings and training programs to understand customer engagement tactics.

Role Description The Associate Director, Clinical Development – Neurology provides clinical development leadership and scientific expertise to one or more project teams, supporting the successful design and execution of development plans for Ionis’ investigational assets. Near-term responsibilities focus on leading key aspects of Ionis-sponsored clinical trials, clinical data analysis and interpretation, communication of project information and risks, and contributions to regulatory submissions, publications, and presentations. Over time, the role may have opportunities to contribute to broader clinical development strategy and clinical trial design. This position sits within the neurology franchise (including rare diseases). The primary focus will be neurology, including neuromuscular diseases, neurodegenerative diseases, and rare pediatric neurogenetic disorders. This position can be fully onsite, remote, or hybrid. For remote employees, periodic travel to Ionis’ headquarters in Carlsbad is expected, approximately once per quarter. Responsibilities - Serve as the clinical lead for assigned studies, representing Clinical Development in internal and external interactions and helping ensure successful execution of a high-priority Phase 3 program by: - Developing and maintaining excellent working relationships with investigators and clinical trial teams - Delivering high-quality scientific presentations on company technology, investigational agents, and clinical study issues to investigators and site staff - Providing guidance and/or training for external personnel involved in Ionis clinical studies - Performing ongoing review of clinical study data and operational progress - Identifying emerging risks and partnering with the project team to proactively manage and mitigate them - Lead and/or contribute to the writing and review of key clinical documents for regulatory submissions (e.g., study protocols, Investigator’s Brochures, IND submissions, Clinical Study Reports) - Engage internal and external stakeholders (e.g., key opinion leaders, advocacy organizations, regulators) to obtain advice and feedback that informs development plans, trial designs, and study results - Communicate project information – including study progress, risks, plans, and recommendations – clearly to project teams and Ionis leadership - Lead and/or contribute to analysis of clinical trial data and the preparation of manuscripts, abstracts, posters, and presentations - Maintain up-to-date clinical and technical expertise in the relevant therapeutic areas by reviewing scientific literature, attending key scientific and technical meetings, and partnering with internal medical, research, and commercial teams - Contribute to broader department and corporate objectives, as needed - Other duties as assigned Qualifications - PhD, MD or PharmD with 5+ years of pharma/biotech experience in clinical development - Experience in neurology, rare diseases, and/or pediatrics is highly desirable - Significant experience with cross-functional collaboration (e.g., clinical operations, regulatory, stats, data management) - Experience with protocol/protocol amendment writing and CSR writing - Experience authoring and/or leading Clinical Study Report (CSR) development. Experience contributing to NDA filings is highly desirable - Experience leading cross-functional data reviews, experience with elluminate is preferred - Experience supporting FDA Pre-Approval and BIMO inspections is highly desirable - Experience managing vendors/committees (e.g., DSMBs) is highly desirable - Outstanding interpersonal and communication skills, with the ability to flexibly relate to diverse internal and external stakeholders and to build strong, positive relationships across development, research, commercial, and senior leadership - Ability to thrive in a fast-paced, innovative environment - Strong attention to detail and quality combined with the ability to make timely decisions and drive execution - Willingness to engage in thoughtful, interrogative debate around key issues and, when appropriate, to constructively challenge the status quo Requirements - The successful candidate is self-driven and effective both as an individual contributor and a flexible team player - They anticipate and identify risks/problems and excel at problem-solving - They bring a practical, hands-on, “can-do” and time-conscious approach, motivated by doing the things today that will deliver transformative treatments to patients with high unmet need tomorrow Benefits - Ionis offers an excellent benefits package! - Highly competitive benefits Company Description For more information about Ionis and to apply for this position; reference requisition # IONIS004080, please visit our website: http://www.ionis.com The pay scale for this position is $168,820 to $250,502. NO PHONE CALLS PLEASE. PRINCIPALS ONLY. Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.

• The Clinical Account Specialist (CAS) is a field-based role responsible for the launch of Ionis’s first wholly owned commercial product within their respective territory and will possess a deep understanding of the healthcare market and the Familial Chylomicronemia Syndrome (FCS) community, including the key customers and accounts treating cardiovascular and lipid related diseases. • The CAS will be responsible for driving performance and working with cross-functional partners and external customers to support Ionis goals and come together to help patients in need. • The CAS will understand the unique objectives and needs of each customer in their pursuit of improved patient outcomes, and will achieve this by building, maintaining, and leveraging networks and relationships in the local healthcare system to develop and execute effective business plans to meet customer and Ionis goals. • The CAS will serve as a cross-functional teammate: building trust and collaborating with a diverse team of people with deep functional and therapeutic area expertise operating with integrity and in compliance with Ionis Code of Ethics and Business Conduct continuing our efforts for the FCS community. • Educate HCPs and office staff to raise FCS disease state awareness, educate on diagnostic pathway, and instill an urgency to treat familial chylomicronemia syndrome (FCS). • Create positive prescribing experience through valuable added resourcing and hcp/patient support materials and programs. • Participate in conferences, congresses, and other scientific meetings to educate HCPs on FCS disease state and treatment. • Gather insights to profile accounts and provide feedback to field leadership and marketing to inform product sales & marketing strategy. • Understand local referral networks, including primary treaters, secondary treaters, and referral patterns for FCS patients. • Identify, validate, and document potential HCPs treating FCS patients to inform commercial strategy.

• Responsible for the launch of Ionis’s first wholly owned commercial product within their respective territory • Build, maintain, and leverage networks and relationships in the local healthcare system • Develop and execute effective business plans to meet customer and Ionis goals • Serve as a cross-functional teammate, building trust and collaborating with a diverse team • Educate HCPs and office staff to raise FCS disease state awareness • Create a positive prescribing experience through value-added resourcing • Participate in conferences and other scientific meetings to educate HCPs on FCS • Execute brand strategic plans by developing customer-focused territory strategic account plans • Adjust strategies to meet business goals in an assigned region

• The Clinical Account Specialist (CAS) is a field-based role responsible for the launch of Ionis’s first wholly owned commercial product within their respective territory • Understand the unique objectives and needs of each customer in their pursuit of improved patient outcomes • Achieve this by building, maintaining, and leveraging networks and relationships in the local healthcare system to develop and execute effective business plans to meet customer and Ionis goals • Serve as a cross-functional teammate: building trust and collaborating with a diverse team of people with deep functional and therapeutic area expertise • Educate HCPs and office staff to raise FCS disease state awareness • Create positive prescribing experience through value added resourcing and HCP/patient support materials and programs • Participate in conferences, congresses, and other scientific meetings to educate HCPs on FCS disease state and treatment • Gather insights to profile accounts and provide feedback to field leadership and marketing to inform product sales & marketing strategy • Understand local referral networks, including primary treaters, secondary treaters, and referral patterns for FCS patients • Identify, validate, and document potential HCPs treating FCS patients to inform commercial strategy • Execute the brand strategic plans by developing and executing customer focused territory strategic account plans to maximize business opportunities and customer satisfaction • Partner with cross-functional teammates to understand and address the unique needs of their customers.

• Building and managing long-term relationships with physicians, Centers of Excellence (COEs) and other customers for the accounts in their assigned territory • Providing access/reimbursement support and product/disease education to the accounts • Delivering key promotional messages to advocate on behalf of people suffering from Alexander disease (AxD) • Representing the organization in the AxD community educating external Healthcare Professionals (physicians, nurses, billing managers, pharmacists, office/hospital staff and other account stakeholders) about the approved indication and clinical information in relation to the AxD disease state • Supporting healthcare provider offices with access & reimbursement support in a compliant manner • Building, maintaining, and leveraging networks and relationships in the local healthcare system to develop and execute effective business plans to meet customer and Ionis goals • Collaborating effectively and compliantly with other Account Specialists and other field teams (e.g., Patient Education Managers, Field Medical Directors) in pursuit of customer/account success

Role Description This position reports to the Assistant Director, Compliance Operations, Systems & Process Lead. The Compliance Operations Manager or Senior Manager supports the day-to-day execution of Ionis’ Healthcare Compliance Operations activities, including: - HCP engagement operations - Transparency reporting - Compliance systems - Operational data quality - Reporting and dashboards - Business process execution This role serves as a key operational partner for core workflows, collaborating across various departments to support compliant, scalable, and efficient operations. The position also supports operational excellence through: - Systems support - Training assistance and coordination - Technology enablement - Continuous improvement This is a remote role for candidates in the U.S., with preference given to individuals located in or near the Boston, MA area to enable periodic on-site collaboration. Responsibilities - Provide daily Healthcare Compliance Operations support and triage for operational inquiries, including compliance mailbox management, request routing, follow-up tracking, and timely resolution. - Support the full HCP engagement lifecycle, including business needs assessments, due diligence, FMV tiering, contracting, and payment documentation. - Administer HCP engagement and other compliance systems, including user support, configuration coordination, testing, troubleshooting, and issue resolution. - Support transparency reporting operations, including data collection, processing, reconciliations, validation, remediation, and reporting readiness for timely and accurate submissions under U.S. federal, state, and ex-U.S. disclosure requirements. - Manage operational data quality initiatives and partner with stakeholders to resolve data issues, monitor trends, and strengthen process controls. - Develop and maintain SOPs, business rules, process maps, work instructions, FAQs, job aids, training materials, and related communications for HCP engagement and transparency reporting processes and systems; deliver end-user training and onboarding. - Coordinate user acceptance testing, system implementations, upgrades, enhancements, and change management activities for compliance-related technologies and workflows. - Track KPIs, operational metrics, dashboards, recurring reports, and trends; recommend corrective actions and process improvements. - Develop operational reports and presentation materials using HCP engagement and transparency data. - Identify automation and emerging digital tools, including AI-enabled workflow solutions, to reduce manual effort, improve user experience, and strengthen controls. - Support audit readiness, inspections, internal monitoring activities, and regulatory inquiries by maintaining accurate, complete, audit-ready documentation, system records, and evidence of key controls. - Support broader Compliance Operations priorities, cross-functional projects, and other day-to-day operational needs as required (e.g., training and communications, compliance ambassador program, etc.). Qualifications - Bachelor’s degree required. - For the Manager position, at least 2 years of related experience in pharmaceutical, biotechnology, medical device healthcare compliance operations with a Bachelor’s degree. - For the Senior Manager position, at least 5 years of related experience in pharmaceutical, biotechnology, medical device healthcare compliance operations with a Bachelor’s degree (or 3+ years with an advanced degree). - Direct experience with HCP engagement, transparency reporting, and compliance systems administration. - Strong understanding of HCP engagement lifecycle activities, including business needs assessments, FMV tiering, due diligence, contracting, payment documentation, and related process controls. - Experience working with data from multiple systems to identify trends, resolve issues, and generate operational insights. - Experience with aggregate spend and transparency reporting, including U.S. federal, state, and ex-U.S. disclosure requirements. - Knowledge of healthcare compliance requirements and industry guidance, including the Anti-Kickback Statute, FCPA, PhRMA Code, OIG guidance, and PDMA. - Experience implementing, administering, or supporting compliance technologies and digital workflow solutions including AI-enabled tools and other operational technologies. - Experience with process improvement, system implementation, reporting, or cross-functional initiatives. - Strong Excel skills, plus Power BI, Tableau, or similar dashboarding and visualization tools. - Ability to translate regulatory requirements into practical, system-enabled processes. - High level of integrity and ability to protect proprietary and confidential information. - Occasional domestic travel of up to 20%. What We Seek in a Candidate - Self-motivated with strong analytical, organizational, and communication skills and able to work independently and collaboratively in a team environment. - Ability to convey complex information clearly to diverse audiences. - Comfortable managing multiple priorities in a fast-paced, dynamic environment. - Agile and willing to take on new projects and additional responsibilities as needed. Compensation - The pay scale for this position is $72,800 to $129,967. - The pay scale for the Manager position is $72,800 to $106,562. - The pay scale for the Senior Manager position is $90,310 to $129,967. Benefits Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits Application Process Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS004065. NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

• Develop and lead U.S. market access strategies aligned with brand and portfolio objectives across a 3+ year horizon. • Define value proposition and access roadmap from pre-launch through lifecycle management. • Shape and implement integrated evidence plans, in partnership with HEOR and Medical Affairs to support access and payer negotiations • Serve as the enterprise subject matter expert on access, payer dynamics, and policy trends across the landscape and within specialty and rare disease • Oversee development of AMCP dossiers, payer communication tools (including Pre-approval Information Exchange and Payer Value Proposition) and field access tools (including product coverage, prior authorization criteria and patient support options). • Guide economic modeling and budget impact analyses to support payer discussions • Collaborate and partner closely with Commercial to align access strategy with brand strategy. • Engage with Government Affairs on policy implications and advocacy priorities. • Represent the organization in external advisory boards and industry forums. • Monitor payer landscape, competitive dynamics, and regulatory changes to inform strategy. • Lead, coach, and develop high-performing Market Access professionals. • Select and retain agency partners, holding full budget authority for access strategies • Drive cross-functional alignment in matrixed environments.