Neurology Clinical Development Lead — Remote

Ionis Pharmaceuticals, Inc.; Carlsbad (CA); Hybrid; USD 169,000 - 251,000; Full time

Benefits offered by this job

Ionis Benefits

Job summary

Ionis Pharmaceuticals, Inc. seeks an Associate Director, Clinical Development – Neurology to lead clinical development activities for neurology assets, including planning and execution of Phase 3 programs, data analysis, and regulatory strategy.

The role may require onsite, remote or hybrid work with periodic travel to Carlsbad. The candidate will lead study design, contribute to CSR writing, engage with investigators and regulators, and help communicate study progress to senior leadership.

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 (clinical ops, regulatory, stats, data management).
• Experience with protocol/protocol amendments and CSR writing; NDA filings desirable.
• Outstanding communication and leadership skills across diverse stakeholders.

Responsibilities

• Serve as clinical lead for assigned studies and support high-priority Phase 3 programs.
• Develop relationships with investigators and trial teams.
• Deliver high-quality scientific presentations to investigators and site staff.
• Provide guidance for external personnel involved in Ionis studies.
• Perform ongoing review of study data and operational progress.
• Identify risks and work with teams to mitigate them.
• Lead/contribute to CSR writing and regulatory documents.

Skills

PhD/MD/PharmD

Neurology experience

Cross-functional collaboration

CSR writing

Regulatory submissions

Education

PhD/MD/PharmD

Tools

Elluminate

Job description

Ionis Pharmaceuticals, Inc. seeks an Associate Director, Clinical Development – Neurology to lead clinical development activities for neurology assets, including planning and execution of Phase 3 programs, data analysis, and regulatory strategy.

The role may require onsite, remote or hybrid work with periodic travel to Carlsbad. The candidate will lead study design, contribute to CSR writing, engage with investigators and regulators, and help communicate study progress to senior leadership.