Associate Director, Clinical Development Neurology

Ionis Pharmaceuticals, Inc.•Carlsbad, CA

23d

About The Position

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’re pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and 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 that our success is a direct result of the exceptional talents 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, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive. We’re building on our rich history, and we believe our greatest achievements are ahead of us. If you’re passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career! The Associate Director provides clinical development support to one or more Project Teams to ensure the successful design, implementation, and execution of development plans for Ionis assets. Major areas of responsibility include: Designing, or assisting with the design of, Ionis-sponsored clinical trials and natural history studies; executing those studies in collaboration with the cross-functional team Identifying translational medicine needs (target engagement assays, biomarkers, natural history studies, etc.) and creating development plans to enable successful clinical development 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, study designs, and study results Communicating project information and plans to the cross-functional team and Ionis leadership Contributing to regulatory submissions, publications, and presentations This position will be in the neurology franchise.

Requirements

PhD in a scientific field with 5+ years’ work experience in the biopharmaceutical industry. Preference will be given to candidates with direct experience working as a clinical scientist in Phase 2 or Phase 3 trials.
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.
Demonstrated record of executing clinical studies is expected; experience in designing, planning, and executing clinical trials and/or natural history studies is highly desirable
Experience providing leadership and guidance to cross-functional project teams
Experience in neurology, rare diseases and/or pediatrics is preferred
Experience in innovative clinical trial designs is highly desirable
A strong basic science background is highly desirable
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

Responsibilities

Contribute to design and execution of clinical studies in collaboration with the cross functional team and external medical/scientific advisors, thought leaders and clinical investigators
Manage clinical development activities during study conduct. Facilitate conduct of clinical studies by: Performing ongoing review and analyses of clinical study data in conjunction with cross functional team Leading cross functional readiness to ensure timely, high-quality clinical data to meet internal data needs and enable program-level decision making 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 involved in Ionis’ clinical studies Leading and maintaining development of cross-functional risk assessment tool to enable risk-based quality management in Ionis’ clinical studies
Contribute to integrated clinical development plans outlining development pathway and evidence required from clinical trials to achieve regulatory approval and market access
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 design novel and efficient clinical programs
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
Lead/contribute to preparation of clinical study manuscripts, posters and presentations
Maintain clinical and technical expertise in the therapeutic area(s); review scientific journals, attend scientific and key technical meetings
Assist in accomplishing department and corporate objectives
Other duties as assigned

Benefits

Ionis offers an excellent benefits package!
Follow this link for more details: Ionis Benefits [https://ionis.com/careers#:~:text=Highly%20competitive%20benefits]
Full Benefits Link: https://ionis.com/careers#:~:text=Highly%20competitive%20benefits

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