Ionis Pharmaceuticals, Inc., located in the North San Diego County city of Carlsbad, was founded in 1989 to create advanced, novel medicines to treat diseases with an unmet medical need. We are the pioneer and leader in the discovery and development of antisense
drugs. By exploiting various cutting-edge RNA targeting technologies, we are capable of specifically and efficiently targeting any gene of interest, including ones which are not targetable by small molecules or antibodies. We currently have three approved
drugs, and a robust pipeline of over 30 drugs in various stages of clinical trials.
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 individuals with different skill sets
into this creative environment to be part of a productive team. Join us and experience our unique culture while you develop and expand your career.
DIRECTOR/ EXECUTIVE DIRECTOR- CLINICAL DEVELOPMENT
Reporting to the Vice President of Clinical Development, the Director/Executive Director of Clinical Development will provide strategic leadership within the therapeutic area franchise and clinical leadership to one or more Clinical Project Teams to ensure
successful design and implementation of Clinical Development Plans. Major areas of responsibility include strategic leadership in the assigned therapeutic area(s), design and ownership of the Clinical Development Plans, KOL liaison and management, clinical
trial design, medical monitoring of Ionis-sponsored clinical trials, clinical data analysis, internal and external communication of project information and plans, and contributions to regulatory submissions, publications and presentations.
- Making key tactical and strategic decisions related to the assigned project(s)
- Developing and keeping current the Clinical Development Plans
- Designing clinical trials and writing/reviewing protocols and other critical study documents (Investigator Brochures, IND submissions, Clinical Study Reports, etc.)
- Leading action-oriented, project team meetings and periodic project reviews, including setting appropriate agendas and communicating decisions
- Identifying emerging risks and managing them with the Project Manager and other team members as appropriate
- Acting as a Medical Monitor for Ionis-sponsored clinical trials
- 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 development plans
- Maintaining medical/scientific standards, educating team members & managing the Scientific Advisory Boards (SAB)
- Involvement in management (and other oversight) committee meetings, including Development Management Committee (DMC) and Research Management Committee (RMC)
- Interacting with regulatory agencies, in concert with the Regulatory Affairs Department
- Representing project(s) to corporate partners, investors and clinical investigators as required
- Developing and overseeing the project budgets with assistance from the Project Manager and Development Controller
- Developing external advocates for the company’s technology, products, and direction
- Facilitating the effective conduct of clinical trials by:
- Developing and maintaining excellent working relationships with investigators
- Ensuring that all GCP requirements are consistently met
- 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
- Performing clinical study data review and analyses in conjunction with Biometrics
- Mentoring Clinical Scientists, Clinical Fellows, Project Managers and Project Team Members while providing clinical education support for internal company customers
- 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
- Performing other duties as assigned
- MD degree or its equivalent; specialty training in cardiology (Board Certification is a plus)
- At least 5 (Director) to 8 (Executive Director) years of Clinical Research experience (with at least 3 years obtained in the Pharmaceutical Industry) and excellent knowledge of the drug development process
- Hands-on experience of designing and conducting clinical trials in heart failure is essential; additional experience in other therapeutic areas within the Ionis portfolio would also be desirable
- Comprehensive and detailed experience of clinical trial design, implementation and sponsor/site interactions in conduct of clinical trials
- Must have experience working in a leadership role within the multidisciplinary project team, e.g. member of a core project team, sub-team leader or study team leader, etc.
- Effective communication skills (including writing and presentation skills) with success in influencing at all levels cross-functionally
- Proven leadership abilities in a highly complex and fast-paced environment where negotiation skills are essential for success
- Excellent business acumen and demonstrated ability to align teams to the corporate strategy and drive to achieve business and project objectives
- Experience working with corporate partners would be an advantage
Excellent salary and benefits package offered.
Please visit our website,
www.ionispharma.com, for more information about Ionis and to apply for this position; reference requisition # 18-0162
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers