Director, Clinical Development

Company Overview

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!

Summary

Provide clinical leadership and involvement in one or more Clinical Project Teams to ensure the successful design and implementation of Clinical Development Plans. Major areas of responsibility include:

• Clinical trial design (for future programs)
• Planning and strategic execution of ongoing Ionis-sponsored clinical trials
• Clinical data analysis
• Communication of project information and plans
• Contributions to regulatory submissions, publications including the CSR and presentations

This position will focus on the neurology therapeutic area, including Alexander disease.

Responsibilities

Facilitating the conduct of clinical trials by:

• Developing and maintaining excellent working relationships with internal cross-functional team to function as the Clinical Development lead for an ongoing Phase 3 clinical trial
• Reviewing clinical study data
• Delivering high quality and succinct scientific presentations on company technology, investigational agents and/or clinical study issues internally, to investigators and clinical site teams
• Working with patient advocacy groups and other groups on natural history and biomarker studies to fill gaps in clinical development pathways
• Interacting with regulatory agencies, in concert with the Regulatory Affairs Department and Project Team Lead, to develop novel and efficient clinical programs in rare neurological diseases without clearly defined developmental pathways
• Designing or assisting with design of clinical trials and contribute to the writing/review of protocols and other critical study documents (Investigator Brochures, IND submissions, Clinical Study Reports, etc.)
• Interacting with external medical/scientific advisors, thought leaders and clinical investigators in the therapeutic area and with internal management and drug development staff to prepare/revise/maintain and efficiently execute the drug development plan
• Leading action-oriented project team meetings and periodic project reviews
• Identifying emerging risks from ongoing clinical trials, aligning with the cross-functional team and managing them in concert with the team, as appropriate
• Developing and overseeing the Clinical Development budget for the project
• Providing clinical education support for internal company team members
• Facilitating, assisting and/or participating in the preparation of clinical study manuscripts by Investigators, internal personnel, and/or contract writers
• Maintaining clinical and technical expertise in the therapeutic area; reviewing scientific journals, attending scientific and key technical meetings and partnering with company medical, research and commercial teams
• Assisting in accomplishing department and corporate objectives
• Other duties as assigned

Competencies Identified For Success

• Demonstrated and capable leadership of a cross-functional team with ability to align the cross-functional team and assume accountability for team decisions and plans.
• 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 across functional areas and with senior management.
• Desire to build a world-class competency-based organization through a combination of vision, energy, drive, enthusiasm and flexibility/adaptability.
• It is imperative that this individual operate successfully both at a strategic level as well as in an operational, hands-on capacity in tight coordination with Clinical Operations within the team structure of Ionis.
• The latter requires a self-motivated, practical, can-do and time-conscious approach that is motivated by the need to do the things today that strategic plans indicate will get a transformative treatment to patients in the future in rare disease setting with limited or no developmental pathway precedent.
• Proactive critical thinking skills to analyze complex issues to weigh risks, develop relevant and realistic plans, programs and recommendations in a developmental program in rare neurologic disease with little or no developmental pathway precedent.
• Ability to thrive in a very fast-paced, innovative environment on complex programs while remaining flexible, proactive, resourceful and getting work done efficiently.
• Attention to detail and quality while also being aware of the need to make timely decisions and to execute.

Requirements

An MD, PharmD and/or PhD with 8 years of strong leadership skills and proven biopharmaceutical industry experience in leading clinical development for late-stage therapeutic programs, with experience in rare diseases, pediatrics and/or neurology strongly preferred. A thorough understanding of the full range of preclinical and clinical development processes would constitute a good fit for this role. A scientific background in addition to medical or PhD training, with focus in the fields of rare disease and/or neurology is strongly preferred. A demonstrated and interrogable record of strategic development planning, leadership and decision-making resulting in successful outcomes is expected. A record of accomplishment including leading the design, planning and execution of Phase 3 clinical studies through data read out and filing is also highly desirable. Excellent writing skills with ability to communicate succinctly and provide necessary level of detail for audience and scope of communication.

Application Process

Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS003638.

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

The pay scale for this position is $231,289 to $305,100.

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

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