Job Details

Requisition Number 18-0146
Post Date 10/26/2018
Company Akcea
Title Sr. Clinical Scientist - Clinical Development
Employment Type Full Time
Description

Akcea Therapeutics is a biopharmaceutical company focused on developing and commercializing drugs to treat patients with serious rare diseases. Our priority is to bring important new therapeutics to patients in need. In order to do so, we must drive clinical program execution, understand patient and physician needs and work with regulators to gain global approval and market access to these new therapeutics. Akcea has a portfolio of development-stage drugs covering multiple targets and disease states using advanced antisense therapeutics.

Akcea was established by Ionis Pharmaceuticals in late 2014 and was listed on the NASDAQ stock exchange in July 2017 under the symbol “AKCA.” Akcea is a global company headquartered in Cambridge, MA with offices in Carlsbad, CA and across the EU and Canada. 

Akcea is interested in bringing together individuals with different skill sets into this creative environment to be part of a productive team to help us through the development and commercialization of our drugs.

 

SR. CLINICAL SCIENTIST - CLINICAL DEVELOPMENT

The successful candidate will provide technical support to 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, clinical data analysis, internal and external communication of project information and plans and contributions to regulatory submissions, publications and presentations.

RESPONSIBILITIES:

  • The clinical scientist will 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
  • Contribute to the planning and design of clinical studies
  • Contribute and coordinating the writing and updating of clinical study protocols
  • Review clinical study data
  • Establish good working relationships with investigators
  • Provide guidance and/or training for external personnel/parties involved in Akcea’s clinical studies
  • Contribute to the writing and review of patient narratives and clinical study reports
  • Facilitate, assist and/or participate in the preparation of clinical study manuscripts by Investigators, internal personnel, and/or contract writers
  • Develop external advocates for the company’s technology, products, and direction
  • Provide clinical education support for internal 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
  • Proactively provide feedback on emerging clinical/competitive trends
  • Contribute to the writing and updating of Investigator Brochures, IND annual reports, and annual reports to regulatory agencies
  • Assist in accomplishing department and corporate objectives
  • Other duties as assigned

REQUIREMENTS:

  • Advanced degree (Pharm.D., Ph.D., M.D.) with 5+ years of Clinical or Pharmaceutical experience and knowledge of the drug development process preferred
  • Prior management experience and/or team leadership skills
  • Cardiometabolic or neurological experience is preferred
  • Excellent written and verbal communication skills
  • Working knowledge of data organization and analysis
  • Strong public presentation skills
  • Comprehensive and detailed knowledge of clinical trial implementation and sponsor/site interactions for clinical trials is preferred
  • An ability to be productive and successful in an intense work environment

 

Excellent salary and benefits package offered.

For more information on Akcea and to apply for this position, please visit our website: www.akceatx.com 

Reference #18-0146

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Akcea Therapeutics, Inc. is proud to be an EEO employer.

 

 

 

 

 

 

 

 

 

 

 

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