Assistant Director, Clinical Development Manager

Assistant Director, Clinical Development Manager Job Category: Development - Ionis Requisition Number: IONIS003647 Posted: March 16, 2026 Full-Time Locations Showing 1 location 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!

ASSISTANT DIRECTOR, CLINICAL DEVELOPMENT MANAGER

SUMMARY:

TheAssistant Director,Clinical DevelopmentManagerprovides support tothe Clinical Development Department andClinical DevelopmentTeams to ensureclinical trialsareready for inspectionandare conducted according to GCP and SOPs.For the Clinical Development Department, responsibilitiesmayincludedeveloping tools to support SOP compliance and supporting processes tofacilitatecompliance with SOPs and onboarding new employees to the department.For Clinical Development Teams, responsibilitiesmayincludesupporting the management of key clinical development activities,including ongoing data review andongoing risk assessments,ensuringappropriate documentsare updated and filed throughouta study.Primary responsibilitiesincludeaiding the Project Team LeadsonvariousIonis’ clinical development programs, vendor managementand helping with onboarding new team members, as well as providing SOP training andconducting process improvement initiatives.

RESPONSIBILITIES:

In partnership with the Project Team Leader, collaborate with cross-functional team members to ensure proper oversight, maintenance, and management of Clinical Development trial documentation. Supports the completion, maintenance, and filing of the RACT tool, including scheduling cross-functional meetings for ongoingmanagement. Conducts reviewsofthe TMF Plan and TMF Index,annually andatregular intervals during the study, uploadsstudy documents (e.g.Blinding Plans, ODR Plans and meeting minutes, etc.),andperformsperiodic SME QC checks. Facilitatesteam reviewsand ensuresdocumentation of team review and training of Protocols, Protocol Amendmentsand Protocol Clarification Letters (PCLs)arefiled,as well as support QC reviewof these documents. Reviews the contracts, scope of work, invoices,and is thedirect contact for vendors.Ensurestheappropriate teammembers review the charters/plans/key documents from the vendorandsupportsvendor oversight. Maintainsstudy plans owned by Clin ical Dev elopment (e.g.ODR Plans,Blinding Plans, vendor oversight plans) andinitiateteam review, sign-off, training and filing. Provides support withfiling andadditionalassistance as needed for Medical Monitoringactivities. Collaboratewith the Project Team Leader,organizethe DSMB and similar oversight committees’ charters, activities,meetings,and documentation. Attendsinternal team meetings(e.g.CTTMs)to be aware of project status and issues on thestudytosupport Clin ical Dev elopment action items. SupportsInspection Readiness activitieswhich includeassisting with storyboarding, responding to inspector requests, attending prep meetings, and supporting the back-room team during inspections. Actsas lead advocate, with the Project Team Leader,forinternal and external audiences. Assistsin accomplishing department and corporateobjectives,e.g.developing tools to support SOP compliance and supporting processes tofacilitatecompliance with SOPs and onboarding new employees to the department.

COMPETENCIES IDENTIFIED FOR SUCCESS

Excellent written and verbal communication skills Strong attention to detail and problem-solving skills Comprehensive and detailed knowledge of clinical trial implementation and sponsor/site interactions for clinical trials is preferred Experience with clinical documentation andTrial Master File (TMF)management and inspection readiness Cross-functional clinical team collaboration Strong understanding of ICH-GCP andclinical trial operations Ability toworkin a fast-paced work environment

REQUIREMENTS:

Bachelor’s or Master’sdegreeina lifesciences or related field 6+years of directly relevant experiencerequired Please visit our website, for more information about Ionis and to apply for this position; reference requisition # IONIS003647 Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits The pay scale for this position is $132,798 to $168,896

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor. #J-18808-Ljbffr Ionis Pharmaceuticals, Inc.