Director, Clinical Development Neurology

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases.

We are pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs.

With five currently marketed medicines for serious diseases and an expansive late-stage pipeline, we continue to build upon our groundbreaking innovations in science and technology to provide greater value to patients;

and we are well positioned financially to deliver on our strategic goals.

At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence.

We know our success is a direct result of the exceptional talent and dedication of our employees.

With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team.

We continue to invest time, money, and energy into making our onsite and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

We are building on our rich history, and believe our greatest achievements are ahead of us. We invite you to apply and join us if you’re passionate about the opportunity to have meaningful impact on patients in need, our employees, and our organization.

Experience and contribute to 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 :

• May serve as clinical / 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.
• 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.

• 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.
• 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
• Analyzing and interpreting data from clinical trials and natural history studies
• Engaging internal and external stakeholders (key opinion leaders, advocacy organizations, etc) to obtain advice and feedback on development plans, trial designs and study results
• Communicating project information and plans to the cross-functional team and leadership
• 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
• Lead / contribute to the writing / review of clinical documents for regulatory submission (study protocols, Investigator Brochures, IND submissions, Clinical Study Reports, etc.)
• Lead action-oriented development team meetings and periodic project reviews including setting appropriate agendas and approving actionable minutes
• Identify emerging risks and manage them with the team as appropriate
• Mentor the development team and provide clinical education support for internal company customers
• Lead / contribute to preparation of clinical study manuscripts, posters, and presentations
• Maintain clinical and technical expertise in the therapeutic area; review scientific journals, attend scientific and key technical meetings
• Assist in accomplishing department and corporate objectives
• Other duties as assigned

REQUIREMENTS :

• A PhD in biomedical science or epidemiology with 4+ years work experience in the biopharmaceutical industry. Preference will be given to candidates with direct experience working as a clinical scientist in Phase 1-3 studies.
• Demonstrated record of designing, planning and executing clinical studies is expected.
• Experience providing leadership and guidance to project teams.
• Experience in neurology, rare diseases and / or pediatrics is preferred.
• Experience in designing, planning and executing clinical studies and / or natural history studies is highly desirable.
• A strong basic science background with an understanding of assay development methodologies and clinical trial enabling nonclinical studies is highly desirable.
• 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.

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.

• Ability to work on multiple programs and thrive in a fast-paced, innovative environment
• Attention to detail and quality while also being aware of the need to make timely decisions and to execute
• Salary contingent upon experience

Benefits

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