Job Details

Requisition Number 17-0122
Post Date 1/12/2018
Company Ionis
Title Clinical Development Data Scientist
Employment Type Full Time
Description

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.

CLINICAL SCIENTIST- CLINICAL DEVELOPMENT

Our Clinical Scientist is an individual contributor who provides technical support to one or more Clinical Project Teams to ensure the successful design and implementation of Development Plans. Major areas of responsibility include clinical trial design, clinical data analysis, internal and external communication of project information and plans, and contributions to regulatory submissions, publications and presentations.  Primary responsibilities will be on Ionis’ Rare Disease or Neurology clinical development programs, although the candidate may also work in other indication areas.

RESPONSIBILITIES:

  • In conjunction with the Project Team Leader, interact with external medical/scientific advisors, thought leaders and clinical investigators in the therapeutic areas as well as with internal management and drug development staff to prepare/revise/maintain and efficiently execute the drug development plan
  • Facilitate clinical trials in conjunction with Project Leader, Project Physician, and Clinical Operations by:
    • Writing/editing protocols
    • Analyzing clinical study data and making recommendations
    • Reviewing and selecting assays for pharmacodynamic endpoints or biomarkers
    • Contribute to, and coordinate, the writing and updating of clinical study protocols, Investigator Brochures, IND annual reports, clinical study reports and submissions and annual reports to regulatory agencies
    • Provide clinical education support for internal and external customers
  • 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 business teams
  • Act as lead advocate, with the Project Team Leader, with internal and external audiences
  • Develop external advocates for the company’s technology, products, and direction
  • Proactively provide feedback on emerging clinical/competitive trends
  • Facilitate, assist and/or participate in the preparation of clinical study manuscripts by Investigators, internal personnel, and/or contract writers
  • Assist in accomplishing department and corporate objectives
  • Other duties as assigned

REQUIREMENTS:

  • PhD in the life sciences required
  • A rigorous scientific background, with at least 3 years of Clinical or Pharmaceutical experience and knowledge of the drug development process a must
  • Excellent written and verbal communication skills
  • Strong public presentation skills
  • Strong attention to detail
  • Comprehensive and detailed knowledge of clinical trial implementation and sponsor/site interactions for clinical trials is required
  • Experience in rare disease or neurology drug development is preferred but not required
  • An ability to be productive and successful in an intense work environment

 

Excellent salary and benefits package offered.

For more information about Ionis and to apply for this position, please visit our website, www.ionispharma.com. Reference Requisition # 17-0122

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

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

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