Associate Director, Regulatory Affairs

1 month ago


Canada GlaxoSmithKline Full time
About the Role

We are seeking an experienced Associate Director to join our Epidemiology Department at GlaxoSmithKline. As a key member of our team, you will provide scientific leadership in the application of epidemiological expertise and methods to drive Epidemiology strategy and studies across the spectrum of drug development.

Key Responsibilities
  • Develop and execute the Epidemiology strategy across the entire spectrum of drug development, from early drug discovery to registration and lifecycle management.
  • Identify new vendors, tools, and data sources to deliver epidemiology solutions for the asset/disease area.
  • Contribute to strategic initiatives on the role of Epidemiology at the departmental level.
  • Represent GSK on scientific discussions with internal governance bodies and external regulators/external conferences.
  • Accountable for the program of epidemiology for an asset or disease area.
  • Bring RWE insights to inform asset/disease area strategy, development activities for one asset or disease area.
  • Propose and negotiate content of epidemiologic program and budget with matrix leader.
  • Provide expert epidemiological consultation to asset matrix teams.
Requirements
  • PhD in Epidemiology or other Quantitative Public Health discipline.
  • Experience operating in a matrix environment with independent delivery of increasingly complex epidemiological studies including regulatory requirements.
  • Demonstrated epidemiological expertise and developing the ability to influence key internal (matrix leaders) and external (regulators) stakeholders.
  • ~ years in the pharmaceutical industry or equivalent experience in an academic or government setting preferred.
  • Expertise in complex research techniques, tools, and procedures.
  • Broad knowledge of private and public use datasets.
About Us

We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology and oncology). We are committed to equal employment opportunities and welcome applications from diverse candidates.



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