Director / Executive Director

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/EXECUTIVE DIRECTOR - CLINICAL DEVELOPMENT CARDIOVASCULAR The Director/Executive Director provides clinical development leadership to more than one project teams to ensure the successful design and execution of clinical development plans. 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 contributions to regulatory submissions, publications and presentations. This position will focus in the cardiovascular therapeutic areas. RESPONSIBILITIES: Design clinical development plans; serve as program lead in internal and external interactions, championing programs and positioning them for success Acting as a Medical Monitor for Ionis-sponsored clinical trials (if medically qualified) Interact with regulatory agencies, in concert with the Regulatory Affairs Department, to develop novel and efficient clinical programs in both rare and common disease populations Design clinical trials and contribute to development of protocols and other critical study documents (Investigator Brochures, IND submissions, Clinical Study Reports, etc.) Establish external medical/scientific advisory teams and interact with thought leaders and clinical investigators in the therapeutic area to prepare/revise/maintain and efficiently execute the drug development plan Lead action-oriented project team meetings and periodic project reviews including setting appropriate agendas and approving actionable minutes Lead, manage the performance of, and develop, direct reports Identify emerging risks and manage them with the team as appropriate Develop and oversee the project budget with the Project Manager and Development Controller Facilitate the conduct of clinical trials by: Developing and maintaining excellent working relationships with investigators 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' clinical studies Reviewing clinical study data and performing analyses in conjunction with Biometrics Mentor the project team, including any clinical scientists and project team leaders directly or indirectly reporting to this position, and provide clinical education support for internal company customers Facilitate and participate in the preparation of clinical study manuscripts with Investigators, internal personnel, and/or contract writers Maintain clinical and technical expertise in the therapeutic area; review scientific journals, attend scientific and key technical meetings and partner with company medical, research and commercial teams Assist in accomplishing department and corporate objectives Other duties as assigned REQUIREMENTS: Ph.D. and/or M.D. with strong leadership skills and proven biopharmaceutical industry experience in leading clinical development for early- and mid-stage therapeutic programs. 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 cardiology and phase 3 experience. Experience in development of heart failure drugs would be desirable but not necessary Demonstrated record of strategic development planning, leadership and decision-making resulting in successful outcomes is expected. Demonstrated record of designing, planning and executing clinical studies is expected. 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. Experience providing leadership and guidance to project teams It is imperative that this individual operate successfully both at a strategic level as well as in an operational, hands-on capacity. The latter requires a 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. Ability to thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and getting work done efficiently A proactive ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations Attention to detail and quality while also being aware of the need to make timely decisions and to execute Please visit our website, for more information about Ionis and to apply for this position; reference requisition Ionis offers an excellent benefits package. Follow this link for more details: Ionis Benefits Full Benefits Link :text=our%20employee%20spotlight-,Benefits,-Employees%20are%20rewarded The pay scale for this position is $225,800 to $305,363 NO PHONE CALLS PLEASE. PRINCIPALS ONLY. Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.