EXECUTIVE DIRECTOR, NEUROLOGY CLINICAL DEVELOPMENTSUMMARY:Ionis is seeking an accomplished clinical development leader to join Neurology Clinical Development as Executive Director.
This individual will provide strategic and operational leadership for programs addressing neurologic disorders.
The role will provide leadership and support for integrated development strategy, clinical trial planning and execution, regulatory engagement, data interpretation, and cross-functional decision-making from early development through potential registrational pathways.
This is a highly visible role for a scientific and organizational leader who can operate at both strategic and hands-on levels. The Executive Director will help shape Ionis's growing neurology portfolio, including rare pediatric populations; build, maintain and further enhance high-performing cross-functional teams; and translate development strategy into timely, high-quality execution for patients and families.
Manage, support, and develop clinical-development professionals, providing strategic guidance, meaningful feedback, and opportunities for continued growth and expanded responsibility.
WORK LOCATION: Carlsbad, CA; onsite, hybrid, or remote options available. For remote, travel to Ionis headquarters in Carlsbad is expected approximately once per quarter, in addition to travel required for business meetings, investigator interactions, and scientific or regulatory activities.
KEY RESPONSIBILITIES:- Provide leadership and support for ongoing programs: the further evolution of integrated development plans, target product profiles, clinical strategies, and development milestones, with flexibility to assume additional programs over time.
- Provision of leadership and support in internal governance forums and external interactions, clearly communicating strategy, evidence, risks, options, and recommendations to senior leadership.
- Lead clinical development planning for early-stage programs, including the transition of preclinical assets into first-in-human development and for the progression of clinical programs toward pivotal and registrational strategies.
- Design and oversee clinical studies in neurology populations, including protocol concepts, endpoint and outcome-measure strategies, dose rationale, patient population definition, feasibility, and operational execution.
- Partner with Research, Biomarkers, Health Economics and Outcomes Research, Patient Advocacy, and external experts to address natural history, target engagement, pharmacodynamic, biomarker, and clinical outcome-assessment needs.
- Lead and contribute to regulatory strategies and interactions with health authorities, in partnership with Regulatory Affairs, including submissions, meeting preparation, responses, and development of efficient approaches for Ionis' programs.
- Provide scientific and medical leadership during study conduct, including review and interpretation of clinical data, safety and risk assessment, clinical issue resolution, and communication with investigators and study teams.
- Establish and maintain strong relationships with key opinion leaders, clinical investigators, advocacy organizations, and external scientific advisors in assigned disease areas.
- Lead and/or support action-oriented cross-functional program teams spanning Clinical Development, Clinical Operations, Statistics, Safety, Regulatory Affairs, Research, Medical Affairs, CMC, Commercial, Market Access, and Patient Advocacy.
- Lead and/or support the identification of emerging program risks and dependencies; develop mitigation plans and make timely, evidence-based recommendations on critical decisions and Go/NoGo milestones.
- Contribute to and/or oversee the preparation and review of key clinical and regulatory documents, including protocols, investigator brochures, IND and other regulatory submissions, clinical study reports, briefing documents, publications, abstracts, posters, and presentations.
- Make, or support others to prepare and deliver, high-quality scientific and program presentations to development and research governance committees, senior management, investigators, partners, and other stakeholders.
- Oversee program budgets and resource planning in partnership with Project Management and Finance/Development Control.
- Lead, coach, mentor, and develop direct reports and other clinical development colleagues. Establish clear expectations, decision rights, and accountability; provide support and challenge without micromanagement; and create opportunities for increasing ownership, leadership growth, and career development.
- Build an inclusive, accountable, and high-performing environment in which program leaders and scientists can grow their influence and operate with appropriate autonomy.
- Share learnings across the Neurology Clinical Development organization and contribute to department-wide process improvement and corporate objectives.
QUALIFICATIONS:- MD, PhD, PharmD, or another advanced degree in medicine, neuroscience, pharmacology, biology, or a related scientific discipline with 15+ years of experience.
- Significant biopharmaceutical industry experience in clinical development, with a demonstrated record of leading early- through mid-stage programs and multidisciplinary project teams.
- Experience in rare disease, pediatric neurology, neurodevelopmental disorders, epilepsy, or a closely related therapeutic area; experience with genetically defined patient populations is strongly preferred.
- Demonstrated ability to develop and execute integrated development plans and clinical strategies across more than one program or indication, with the breadth and adaptability to take on additional programs as needed.
- Experience designing, planning, and executing clinical studies, including studies involving small or heterogeneous patient populations and meaningful endpoint, biomarker, or natural-history challenges.
- Experience preparing for and participating in regulatory submissions and health-authority interactions, preferably with novel development approaches or rare disease programs.
- Strong understanding of the end-to-end drug development process, from translational and preclinical development through clinical development and potential registration.
- Demonstrated scientific credibility through relevant research, publications, clinical practice, or sustained engagement with external experts and the medical/scientific community.
- Experience working effectively with external partners, investigators, vendors, patient organizations, and key opinion leaders.
- Experience leading, mentoring, coaching, and developing direct reports and/or cross-functional team members, including individuals growing into broader leadership roles.
COMPETENCIES FOR SUCCESS:- Strategic thinker who can translate scientific and clinical complexity into clear priorities, decisions, and executable plans.
- Hands-on, practical, and action-oriented leader who can move work forward in a lean and entrepreneurial environment.
- Empowering people-leader who sets direction and accountability while giving capable colleagues room to lead, make decisions, and grow.
- Collaborative leader who builds trust, develops talent, and creates a safe and inclusive environment for high performance
- Exceptional communication and interpersonal skills, with the ability to influence without relying on hierarchy and to engage effectively with scientific and clinical experts.
- Rigorous and transparent approach to data, risk, quality, and patient safety.
- Decisive, resourceful, and comfortable making recommendations in situations of uncertainty or incomplete information.
- Passion for advancing transformative treatments for patients and families living with neurological disorders.
Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS004128
Ionis offers an excellent benefits package! Follow this link for more details:
Ionis BenefitsFull Benefits Link: https://ionis.com/careers#:~:text=Highly%20competitive%20benefits
The pay scale for this position is $269,100 to $339,900
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
