Assistant Director, Clinical Development Manager

Ionis•Carlsbad, CA

24d•$132,798 - $168,896

About The Position

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: The Assistant Director, Clinical Development Manager provides support to the Clinical Development Department and Clinical Development Teams to ensure clinical trials are ready for inspection and are conducted according to GCP and SOPs. For the Clinical Development Department, responsibilities may include developing tools to support SOP compliance and supporting processes to facilitate compliance with SOPs and onboarding new employees to the department. For Clinical Development Teams, responsibilities may include supporting the management of key clinical development activities, including ongoing data review and ongoing risk assessments, ensuring appropriate documents are updated and filed throughout a study. Primary responsibilities include aiding the Project Team Leads on various Ionis’ clinical development programs, vendor management and helping with onboarding new team members, as well as providing SOP training and conducting process improvement initiatives.

Requirements

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 and Trial Master File (TMF) management and inspection readiness
Vendor/CRO oversight
Cross-functional clinical team collaboration
Strong understanding of ICH-GCP and clinical trial operations
Ability to work in a fast-paced work environment
Bachelor’s or Master’s degree in a life sciences or related field
6+ years of directly relevant experience required

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 ongoing management.
Conducts reviews of the TMF Plan and TMF Index, annually and at regular intervals during the study, uploads study documents (e.g. Blinding Plans, ODR Plans and meeting minutes, etc.), and performs periodic SME QC checks.
Facilitates team reviews and ensures documentation of team review and training of Protocols, Protocol Amendments and Protocol Clarification Letters (PCLs) are filed, as well as support QC review of these documents.
Reviews the contracts, scope of work, invoices, and is the direct contact for vendors.
Ensures the appropriate team members review the charters/plans/key documents from the vendor and supports vendor oversight.
Maintains study plans owned by Clin ical Dev elopment (e.g. ODR Plans, Blinding Plans, vendor oversight plans) and initiate team review, sign-off, training and filing.
Provides support with filing and additional assistance as needed for Medical Monitoring activities.
Collaborate with the Project Team Leader, organize the DSMB and similar oversight committees’ charters, activities, meetings, and documentation.
Attends internal team meetings (e.g. CTTMs) to be aware of project status and issues on the study to support Clin ical Dev elopment action items.
Supports Inspection Readiness activities which include assisting with storyboarding, responding to inspector requests, attending prep meetings, and supporting the back-room team during inspections.
Acts as lead advocate, with the Project Team Leader, for internal and external audiences.
Assists in accomplishing department and corporate objectives, e.g. developing tools to support SOP compliance and supporting processes to facilitate compliance with SOPs and onboarding new employees to the department.