Director, Clinical Development Neurology

Ionis Pharmaceuticals, Inc., is headquartered in Carlsbad, California, with offices in Boston, Massachusetts, and Dublin, Ireland. For more than 30 years, Ionis has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with our novel antisense technology. Ionis currently has three marketed medicines and a premier late-stage pipeline highlighted by industry-leading cardiovascular and neurological franchises. Our scientific innovation began and continues with the knowledge that sick people depend on us, which fuels our vision to become the undisputed leader in genetic medicine, utilizing a multi-platform approach to discover, develop and deliver life-transforming therapies.

As the first company to fully harness the power of RNA technology for human therapeutics, Ionis’ platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. We are building upon our innovative research and drug development excellence to provide greater value to patients, and we are well positioned financially to deliver on our strategic goals.

Ionis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence. Our success is a direct result of our outstanding employees. We are interested in bringing together a diverse group of individuals with different skill sets and perspectives into this creative environment to be part of a productive and inclusive team. While acknowledging people are actively engaged in hybrid/remote work, we continue to invest time, money, and energy into making our workplace locations a place where our culture and employees can thrive. We believe engaging on a day-to-day basis, in person, builds solid and lasting relationships, and contributes positively to our culture and innovation. From the heart of our stunning Carlsbad campus, we aim to provide a central connection point for all our employees. These facilities give us the opportunity to connect cross-functionally, collaborate and to build on the success of our business as we continue to grow. Join us and experience our unique culture while you develop and expand your career.

DIRECTOR, CLINICAL DEVELOPMENT NEUROLOGY

SUMMARY:

The Director provides clinical development leadership and support to one or more Clinical Project Teams to ensure the successful design and implementation of development plans for early-stage assets. Major areas of responsibility include overall development plan design, clinical trial design and execution of Ionis-sponsored clinical trials, clinical data analysis, communication of project information and plans, and contribution to regulatory submission, publications, and presentations. This position will be in the neurology (including rare diseases) franchise.

RESPONSIBILITIES:

• Developing and maintaining excellent working relationships with investigators and study team
• Providing guidance and/or training for external personnel/parties involved in Ionis’s clinical studies
• Lead/contribute to design and execution of clinical trials in collaboration with the cross functional team and external medical/scientific advisors, thought leaders and clinical investigators. Knowledge of innovative clinical study designs is a plus.
• Delivering high quality scientific presentations on company technology, investigational agents and/or clinical study issues to investigators and clinical site staff
• Perform ongoing analyses of clinical study data in conjunction with biostatistics
• May serve as program lead in internal and external interactions, championing programs and positioning them for success
• Lead/contribute to integrated clinical development plans outlining development pathway and evidence required from clinical trials to achieve regulatory approval and market access.
• Manage clinical development activities during study conduct. Facilitate conduct of clinical trials by:
  • Developing and maintaining excellent working relationships with investigators and study team
  • Delivering high quality scientific presentations on company technology, investigational agents and/or clinical study issues to investigators and clinical site staff
  • Providing guidance and/or training for external personnel/parties involved in Ionis’s clinical studies
  • Perform ongoing analyses of clinical study data in conjunction with biostatistics
• Engaging internal and external stakeholders (key opinion leaders, advocacy organizations, etc) to obtain advice and feedback on development plans, trial designs and study results
• Maintain clinical and technical expertise in the therapeutic area; review scientific journals, attend scientific and key technical meetings
• Develop and implement plans to address translational medicine needs and enable successful clinical trials. Collaborate with cross-functional team, external medical/scientific advisers and opinion leaders on target engagement assay development, identification and analysis of biomarkers, analysis of data (natural history, real-world) to inform clinical trial design, and design and execution of natural history studies.
• Assist in accomplishing department and corporate objectives
• Lead action-oriented development team meetings and periodic project reviews including setting appropriate agendas and approving actionable minutes
• Other duties as assigned
• Identify emerging risks and manage them with the team as appropriate
• Analyzing and interpreting data from clinical trials and natural history studies
• Mentor the development team and provide clinical education support for internal company customers
• Engage regulatory agencies, in concert with the Regulatory Affairs Department and cross-functional team, to develop novel and efficient clinical programs in rare disease populations
• Lead/contribute to the writing/review of clinical documents for regulatory submission (study protocols, Investigator Brochures, IND submissions, Clinical Study Reports, etc.)
• Lead/contribute to preparation of clinical study manuscripts, posters, and presentations
• Communicating project information and plans to the cross-functional team and leadership

REQUIREMENTS:

• Experience in rare diseases, pediatrics and/or neurology is preferred.
• Ability to successfully work in a cross-functional environment and create strategic development plans for assets entering clinical trials. Ability to take a proactive and hands-on approach to efficiently operationalize plans is imperative.
• Experience providing leadership and guidance to project teams.
• Elevated interpersonal and communication skills with ability to flexibly relate to both internal and external stakeholders. Ability to develop strong positive relationships with colleagues in Development, Research, and senior management.
• 5+ years relevant experience in translational medicine, basic science research or epidemiology with 3+ years Phase 1-2 clinical research experience
• A strong basic science background with an understanding of assay development methodologies and clinical trial enabling nonclinical studies is highly desirable.
• A PhD in biomedical science or epidemiology with 5+ years work experience in the biopharmaceutical industry and the following:
  • 5+ years Phase 1-2 clinical research experience OR
  • 5+ years relevant experience in translational medicine, basic science research or epidemiology with 3+ years Phase 1-2 clinical research experience
• Attention to detail and quality while also being aware of the need to make timely decisions and to execute
• Experience in designing, planning and executing clinical studies and/or natural history studies is highly desirable.
• Ability to work on multiple programs and thrive in a fast-paced, innovative environment
• 5+ years Phase 1-2 clinical research experience OR
• Demonstrated record of designing, planning and executing clinical studies is expected.

Please visit our website, www.ionispharma.com for more information about Ionis and to apply for this position; reference requisition # IONIS003068

Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits

Full Benefits Link: https://www.ionispharma.com/careers/working-at-ionis/#:~:text=our%20employee%20spotlight-,Benefits,-Employees%20are%20rewarded

The pay scale for this position is $191,536 to $253,583

NO PHONE CALLS, PLEASE. PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.