Assistant Director/ Associate Director, Clinical Development Neurology

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 are pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs.With five currently marketed medicines for serious diseases and an expansive late-stage pipeline, we continue to build upon our groundbreaking innovations in science and technology to provide greater value to patients; and we 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 our success is a direct result of the exceptional talent 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 and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.We are building on our rich history, and believe our greatest achievements are ahead of us.We invite you to apply and join us if you're passionate about the opportunity to have meaningful impact on patients in need, our employees, and our organization.Experience and contribute to our unique culture while you develop and expand your career!ASSISTANT DIRECTOR / ASSOCIATE DIRECTOR, CLINICAL DEVELOPMENT NEUROLOGYSUMMARY: The Assistant Director / Associate Director provides clinical development support to one or more Clinical Project Teams to ensure the successful design and implementation of development plans for early- to late-stage assets.This is an excellent opportunity for candidates with a strong background in drug development, biomedical and/or behavioral sciences, or translational medicine. Major areas of responsibility include: Designing and executing Ionis-sponsored clinical trials and natural history studies in collaboration with the cross-functional teamIdentifying translational medicine needs (target engagement assays, biomarkers, natural history studies, etc) and creating development plans to enable successful clinical trialsAnalyzing and interpreting data from clinical trials and natural history studiesEngaging internal and external stakeholders (key opinion leaders, advocacy organizations, etc) to obtain advice and feedback on development plans, trial designs and study resultsCommunicating project information and plans to the cross-functional team and leadershipContributing to regulatory submissions, publications and presentations.This position will be in the neurology (including rare pediatric neurogenetic) franchise.RESPONSIBILITIES:Contribute to design and execution of clinical trials in collaboration with the cross functional team and external medical/scientific advisors, thought leaders and clinical investigators. Knowledge of innovative clinical study designs is a plus.Manage clinical development activities during study conduct. Facilitate conduct of clinical trials by:Perform ongoing analyses of clinical study data in conjunction with biostatisticsDeveloping and maintaining excellent working relationships with investigators and study teamDelivering high quality scientific presentations on company technology, investigational agents and/or clinical study issues to investigators and clinical site staffProviding guidance and/or training for external personnel/parties involved in Ionis's clinical studiesContribute to integrated clinical development plans outlining development pathway and evidence required from clinical trials to achieve regulatory approval and market access.Develop and implement plans to address translational medicine needs and enable successful clinical trials. Collaborate with cross-functional team, external medical/scientific advisers and opinion leaders on target engagement assay development, identification and analysis of biomarkers, analysis of data (natural history, real-world) to inform clinical trial design, and design and execution of natural history studies.Engage regulatory agencies, in concert with the Regulatory Affairs Department and cross-functional team, to develop novel and efficient clinical programs in rare disease populationsLead/contribute to the writing/review of clinical documents for regulatory submission (study protocols, Investigator Brochures, IND submissions, Clinical Study Reports, etc.)Lead action-oriented development team meetings and periodic project reviews including setting appropriate agendas and approving actionable minutesIdentify emerging risks and manage them with the team as appropriateLead/contribute to preparation of clinical study manuscripts, posters and presentationsMaintain clinical and technical expertise in the therapeutic area; review scientific journals, attend scientific and key technical meetingsAssist in accomplishing department and corporate objectivesOther duties as assignedREQUIREMENTS: A PhD in biomedical or behavioral sciences with 1+ year work experience in biopharmaceutical industry and the following:2+ years Phase 1, 2 or 3 clinical research experience OR1+ years relevant experience in translational medicine or epidemiology, with 1+ years in Phase 1-2 clinical research experience within Clinical DevelopmentUnderstanding of the pharmaceutical industry in general and specific to clinical development.Experience in rare diseases, pediatrics and/or neurology is preferred.Experience in designing, planning and executing clinical studies and/or natural history studies is highly desirable.A strong basic science background with an understanding of assay development methodologies and clinical trial enabling nonclinical studies is highly desirable.Ability to successfully work in a cross-functional environment and create strategic development plans for assets entering clinical trials. Ability to take a proactive and hands-on approach to efficiently operationalize plans is imperative.Elevated interpersonal and communication skills with ability to flexibly relate to both internal and external stakeholders. Ability to develop strong positive relationships with colleagues in Development, Research and senior management.Ability to work on multiple programs and thrive in a fast-paced, innovative environmentAttention to detail and quality while also being aware of the need to make timely decisions and to executePlease visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition #IONIS003505Ionis offers an excellent benefits package! Follow this link for more details: Ionis BenefitsFull Benefits Link: https://www.ionis.com/careers/working-at-ionis/#:~:text=our%20employee%20spotlight-,Benefits,-Employees%20are%20rewardedThe pay scale for this position is $126,000 to $195,000The pay scale for the Assistant Director position is $126,000 to $178,000The pay scale for the Associate Director position is $163,000 to $195,000NO PHONE CALLS PLEASE. PRINCIPALS ONLY.Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.