Associate Director, Clinical Development - Neurology

Summary

The Associate Director, Clinical Development – Neurology provides clinical development leadership and scientific expertise to one or more project teams, supporting the successful design and execution of development plans for Ionis’ investigational assets. Near-term responsibilities focus on leading key aspects of Ionis-sponsored clinical trials, clinical data analysis and interpretation, communication of project information and risks, and contributions to regulatory submissions, publications, and presentations. Over time, the role may have opportunities to contribute to broader clinical development strategy and clinical trial design.

Responsibilities

• Serve as the clinical lead for assigned studies, representing Clinical Development in internal and external interactions and helping ensure successful execution of a high-priority Phase 3 program by:
• Developing and maintaining excellent working relationships with investigators and clinical trial teams
• Delivering high-quality scientific presentations on company technology, investigational agents, and clinical study issues to investigators and site staff
• Providing guidance and/or training for external personnel involved in Ionis clinical studies
• Performing ongoing review of clinical study data and operational progress
• Identifying emerging risks and partnering with the project team to proactively manage and mitigate them
• Lead and/or contribute to the writing and review of key clinical documents for regulatory submissions (e.g., study protocols, Investigator’s Brochures, IND submissions, Clinical Study Reports).
• Engage internal and external stakeholders (e.g., key opinion leaders, advocacy organizations, regulators) to obtain advice and feedback that informs development plans, trial designs, and study results.
• Communicate project information – including study progress, risks, plans, and recommendations – clearly to project teams and Ionis leadership.
• Lead and/or contribute to analysis of clinical trial data and the preparation of manuscripts, abstracts, posters, and presentations.
• Maintain up-to-date clinical and technical expertise in the relevant therapeutic areas by reviewing scientific literature, attending key scientific and technical meetings, and partnering with internal medical, research, and commercial teams.
• Contribute to broader department and corporate objectives, as needed.

Requirements

• The successful candidate is self-driven and effective both as an individual contributor and a flexible team player. They anticipate and identify risks/problems and excel at problem-solving. They bring a practical, hands-on, “can-do” and time-conscious approach, motivated by doing the things today that will deliver transformative treatments to patients with high unmet need tomorrow.
• 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 (e.g., clinical operations, regulatory, stats, data management)
• Experience with protocol/protocol amendment writing and CSR writing
• Experience authoring and/or leading Clinical Study Report (CSR) development. Experience contributing to NDA filings is highly desirable
• Experience leading cross-functional data reviews, experience with elluminate is preferred
• Experience supporting FDA Pre-Approval and BIMO inspections is highly desirable
• Experience managing vendors/committees (e.g., DSMBs) is highly desirable
• Outstanding interpersonal and communication skills, with the ability to flexibly relate to diverse internal and external stakeholders and to build strong, positive relationships across development, research, commercial, and senior leadership
• Strong attention to detail and quality combined with the ability to make timely decisions and drive execution
• Willingness to engage in thoughtful, interrogative debate around key issues and, when appropriate, to constructively challenge the status quo