Director, Drug Safety

Location
80301, Boulder
Salary
Commensurate with Experience
Posted
May 10, 2018
Required Education
Bachelors Degree
Position Type
Full time

miRagen Therapeutics, Inc. is a clinical stage biopharmaceutical company developing proprietary RNA-targeted therapeutics with a specific focus on microRNAs and their role in diseases where there is a high unmet medical need. Using our expertise in RNA-based therapeutics and systems biology we have created a diverse pipeline of RNA-targeted product candidates.

The Director, Drug Safety, is responsible for providing strategic leadership for the Clinical safety monitoring and pharmacovigilance activities in the execution of the Company’s clinical studies while meeting the required quality standards and miRagen Standard Operating Procedures. Primary responsibilities include:

  • Responsible for oversight of the Drug Safety (DS) operational group
  • Accountable for all of the activities and deliverables for the DS operational group
  • Business owner of the safety database
  • Provides and/or assists the clinical development team in the compilation of safety sections on IBs, clinical trial reports, periodic safety reporting, ad-hoc materials for regulatory consultation 
  • Ability to review summarize and interpret medical safety clinical data in individual safety case reports
  • Oversees and leads effective review, reporting and follow-up of any adverse events
  • Initiates and writes queries to clarify information received from individual safety case reports
  • Provides compliance related medical assessments
  • Assesses safety profile by reviewing all safety parameters
  • Assists with developing custom reports to assess safety data including safety signal and trend analyses in the premarketing and post marketing setting
  • Responsible for interpreting aggregate safety data and determining their potential impact (e.g. investigator brochure, development and periodic safety update reports)
  • Participates in overseeing the preparation and management of medical safety documents submitted to the FDA
  • Assists in implementation of the global safety strategy
  • Responsible for meeting defined expectations and commitments on a therapeutic program
  • Gives medical support, advise and expertise regarding clinical issues
  • Works with Clinical Sciences and Operations in the compilation of safety sections of documents (e.g., protocols, study reports, informed consent forms)
  • Leads, guides and develops direct reports and supports the process for successful project teams
  • Interacts with senior management to report on project or program milestones
  • Sets performance standards and responsible for performance management
  • Demonstrates the ability to deal effectively with all functional departments
  • Point of contact and accountability for release of safety data
  • Supports the development the safety sections of internal and external presentations for clinical projects

Qualifications:

  • Minimum of a BS degree with drug safety management experience, global experience a plus.
  • Expertise in large, multi-site, clinical trials
  • 10 years’ experience in drug safety
  • Experience in oncology in the pharmaceutical industry preferred
  • Experience supporting regulatory submissions
  • Able to think creatively and develop and execute in a fast-paced environment
  • Demonstrates excellent organizational skills
  • Effective communicator with strong verbal and written skills
  • Seen as a strong and highly skilled, influential leader and manager of employees
  • Ability to identify issues, analyze situations and provide effective solutions
  • Good understanding of the clinical process is important
  • Knowledge of applicable regulatory and ICH guidance regarding clinical research and GCP

Required Skills and Abilities:

  • In-depth knowledge of best drug safety practices
  • Expert scientific, clinical and analytical base knowledge
  • Solid knowledge of FDA and international regulations
  • Solid understanding of overall business needs
  • Identifies issues, analyzes situations and provides effective solutions
  • Advanced proficiency in Microsoft Office, Microsoft Project
  • Reliable, self-motivated, team player
  • Detail oriented with excellent organizational skills