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’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!

ASSOCIATE DIRECTOR, CLINICAL DEVELOPMENT NEUROLOGY

The Associate Director provides clinical development support to one or more Project Teams to ensure the successful design, implementation, and execution of development plans for Ionis assets.  Major areas of responsibility include:

• Designing, or assisting with the design of, Ionis-sponsored clinical trials and natural history studies; executing those studies in collaboration with the cross-functional team
• Identifying translational medicine needs (target engagement assays, biomarkers, natural history studies, etc.) and creating development plans to enable successful clinical development
• Analyzing and interpreting data from clinical trials and natural history studies
• Engaging internal and external stakeholders (key opinion leaders, advocacy organizations, etc.) to obtain advice and feedback on development plans, study designs, and study results
• Communicating project information and plans to the cross-functional team and Ionis leadership
• Contributing to regulatory submissions, publications, and presentations

This position will be in the neurology franchise.

Responsibilities:

• Contribute to design and execution of clinical studies in collaboration with the cross functional team and external medical/scientific advisors, thought leaders and clinical investigators
• Manage clinical development activities during study conduct. Facilitate conduct of clinical studies by:
• Performing ongoing review and analyses of clinical study data in conjunction with cross functional team
• Leading cross functional readiness to ensure timely, high-quality clinical data to meet internal data needs and enable program-level decision making
• Developing and maintaining excellent working relationships with investigators and study team
• Delivering high quality scientific presentations on company technology, investigational agents, and/or clinical study issues to investigators and clinical site staff
• Providing guidance and/or training for external personnel involved in Ionis’ clinical studies
• Leading and maintaining development of cross-functional risk assessment tool to enable risk-based quality management in Ionis’ clinical studies
• Contribute 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 design novel and efficient clinical programs
• Lead/contribute to the writing/review of clinical documents for regulatory submission (study protocols