Summary
The Associate Director, Clinical Development β Neurology provides clinical development leadership and scientific expertise to one or more project teams, supporting design and execution of development plans for Ionis investigational assets. Focus includes leading Ionis-sponsored clinical trials, clinical data analysis and interpretation, communicating project information and risks, and contributing to regulatory submissions, publications, and presentations. May contribute over time to broader clinical development strategy and clinical trial design.
Responsibilities
- Serve as clinical lead for assigned studies; help ensure successful execution of high-priority Phase 3 programs by:
- Developing and maintaining relationships with investigators and clinical trial teams
- Delivering scientific presentations to investigators and site staff
- Providing guidance/training for external personnel
- Reviewing clinical study data and operational progress
- Identifying emerging risks and proactively managing/mitigating them
- Lead and/or contribute to writing/review of key regulatory clinical documents (e.g., study protocols, Investigatorβs Brochures, IND submissions, Clinical Study Reports)
- Engage internal/external stakeholders (e.g., KOLs, advocacy organizations, regulators)
- Communicate study progress, risks, plans, and recommendations
- Lead/contribute to clinical trial data analysis and preparation of manuscripts, abstracts, posters, and presentations
- Maintain clinical/technical expertise via literature review, meetings, and partnership with internal teams
- Contribute to broader department/corporate objectives; other duties as assigned
Requirements
- PhD, MD, or PharmD with 5+ years in pharma/biotech clinical development
- Self-driven, problem-solving mindset; hands-on, time-conscious βcan-doβ approach
Preferred/Desirable
- Experience in neurology, rare diseases, and/or pediatrics
- Cross-functional collaboration experience (clinical ops, regulatory, stats, data management)
- Protocol/protocol amendment and CSR writing; authoring/leading CSR development; NDA filing contributions
- Cross-functional data reviews; elluminate preferred
- FDA Pre-Approval and BIMO inspection support highly desirable
- Vendor/committee management (e.g., DSMBs) highly desirable
- Outstanding communication/interpersonal skills; ability to build relationships across development, research, commercial, and leadership
- Thrives in fast-paced environment; attention to detail; timely decision-making; constructively challenges status quo
Application
- Apply via ionis.com; reference requisition #IONIS004080.
- NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Benefits/Pay
- The pay scale is $168,820 to $250,502. Ionis offers an excellent benefits package (link provided in posting).