Job Details

Requisition Number 15-0132
Post Date 9/29/2017
Company Ionis
Title Manager or Senior Manager, Disclosure & Transparency
Employment Type Full Time
Description

Ionis Pharmaceuticals, Inc., located in the North San Diego County city of Carlsbad, is the industry leader in the discovery and development of antisense drugs. Ionis was founded in 1989 in order to create advanced, novel medicines to treat complex and challenging diseases. We are the leader in antisense technology and drug development with a pipeline of more than 30 drugs (developed by Ionis and its partners). The Company establishes partnerships with large pharmaceutical and smaller biotechnology companies that provide dedicated and focused drug development and technology in order to maximize the potential of the technology we pioneered. This strategy provides Ionis with significant financial strength through a continuing stream of revenue from upfront license fees and milestone payments. In this way, we remain a powerhouse in antisense technology, discovering new ways to treat disease while remaining small with a core, dedicated group of employees. 

Ionis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence. Our founding goals have changed little in 28 years and 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 developing and expanding your career.

Manager or Senior Manager, Disclosure & Transparency

The Disclosures & Transparency function resides organizationally within Regulatory Affairs and is responsible for Clinical Trial Disclosure and Data Transparency activities.  The overall responsibilities include providing oversight and driving the development strategy, operations and processes to ensure transparency and compliance in line with internal and external requirements.  This manager will ensure comprehensive, high quality and compliant clinical trial registration and results submission of Ionis-sponsored clinical trials on publicly accessible websites, such the Food Drug Administration’s (FDA) Clinical Trials Registry (www.clinicaltrials.gov) and the European Union Clinical Trial Register (www.clinicaltrialsregister.eu). This position may also support transparency activities such as preparation of Policy 0070 packages for submission to the European Medicines Agency (EMA).  This is an individual contributor position.

RESPONSIBILITIES:

  • Develops strategic Disclosures & Transparency initiatives within the group and cross-functionally
  • Works with project team and manages clinical trial disclosure activities, including authorship of new protocol registrations/registration updates and results postings for release on the ClinicalTrials.gov and EU-CTR clinical trial registries.
  • Drives development and implementation of cross-functional processes, procedures and training material related to disclosure and transparency activities
  • Interacts with internal groups such as Clinical Development, Clinical Operations, Project Management, Quality Assurance, Legal, Regulatory Affairs and Corporate Communication, and ensures consistency and alignment of disclosed data across multiple registries, publications and press releases.
  • Participates in redaction of clinical trial documents and generation of redaction justification tables required for Policy 0070
  • Evaluates evolving regulations and guidance documents on clinical trial disclosure and data transparency to maintain Ionis compliance
  • Serves as subject matter expert and corporate resource for disclosure requirements

  REQUIREMENTS:  

  • Bachelor’s degree
  • 5+ years of relevant clinical development or regulatory affairs experience in the pharmaceutical/biotechnology development environment (e.g. Sponsor or Clinical Research Organization)
  • Preferably 3+ years of direct experience in disclosures and/or data transparency, or closely related area (e.g. regulatory, clinical operations trial management, data management or medical writing)
  • Knowledge and understanding of global requirements for clinical trial disclosure and relevant regulations and guidelines
  • Familiarity with Clinicaltrials.gov and EudraCT
  • Core understanding and familiarity with drug development, clinical research and trial design
  • Well-developed computer skills including proficiency in MS Office
  • Ability to work effectively with Clinical Trial Management Systems, Regulatory Document Management Systems (e.g. Documentum, Veeva) and Transparency Management Systems (e.g. PharmaCM)
  • Excellent attention to detail and organizational skills
  • Exceptional oral and written communication skills with an ability to effectively communicate with a variety of teams and individuals, including leadership and members of senior management staff
  • Ability to work both independently and collaboratively with a team and can effectively work on multiple projects simultaneously
  • Ability to be productive and successful in an intense work environment

Excellent salary and benefits package offered.

For more information on Ionis and to apply for this position, please visit our website, www.ionispharm.com

Reference Requisition # 15-0132

NO PHONE CALLS PLEASE.  PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. is proud to be an EEO employer.

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