Associate Director, Clinical Development Neurology

Associate Director, Clinical Development (Neurology)

Responsibilities
- Design or assist in designing Ionis-sponsored clinical trials and natural history studies; execute those studies with the cross-functional team
- Identify translational medicine needs (target engagement assays, biomarkers, natural history studies, etc.) and create development plans for successful clinical development
- Analyze and interpret data from clinical trials and natural history studies
- Engage internal/external stakeholders (e.g., key opinion leaders, advocacy organizations) for advice and feedback on development plans, study designs, and study results
- Communicate project information and plans to the cross-functional team and Ionis leadership
- Contribute to regulatory submissions, publications, and presentations
- Contribute to design and execution of clinical studies with cross-functional teams and external medical/scientific advisors, thought leaders, and clinical investigators
- Manage clinical development activities during study conduct (ongoing data review/analysis; cross-functional readiness for timely, high-quality clinical data; relationships with investigators/study teams)
- Deliver scientific presentations to investigators and clinical site staff
- Provide guidance/training to external personnel involved in Ionis clinical studies
- Lead and maintain a cross-functional risk assessment tool for risk-based quality management
- Develop integrated clinical development plans to support regulatory approval and market access
- Develop/implement translational medicine plans (target engagement assays, biomarkers, natural history/real-world data) and design/execute natural history studies
- Engage regulatory agencies to design novel and efficient clinical programs
- Lead/contribute to writing/review of regulatory documents (protocols, Investigator Brochures, IND submissions, Clinical Study Reports, etc.)
- Lead development team meetings and periodic project reviews
- Identify/manage emerging risks
- Lead/contribute to manuscripts, posters, and presentations
- Maintain clinical/technical expertise; review journals and attend scientific/key technical meetings
- Assist with department and corporate objectives; other duties as assigned

Requirements
- PhD in a scientific field with 5+ years’ biopharmaceutical industry experience; preference for clinical scientist experience in Phase 2 or Phase 3 trials
- Ability to work cross-functionally and create strategic development plans; proactive, hands-on operationalization of plans
- Demonstrated execution of clinical studies; experience designing/planning/executing clinical trials and/or natural history studies (highly desirable)
- Leadership and guidance experience for cross-functional project teams
- Communication/interpersonal skills to relate with internal/external stakeholders and build relationships
- Ability to work on multiple programs in a fast-paced environment
- Attention to detail and quality with ability to make timely decisions and execute

Preferred
- Experience in neurology, rare diseases and/or pediatrics
- Experience in innovative clinical trial designs
- Strong basic science background

Benefits
- Pay scale: $165,000 to $215,000

Application Instructions
- Apply via the website (http://www.ionis.com) and reference requisition #IONIS004009
- No phone calls; principals only