Associate Director, Clinical Development & Analytics

Novartis Pharmaceuticals East Hanover , NJ 07936

Posted 6 months ago

Job Description:

The Clinical Development & Analytics Associate Director (CD&A-AD) is responsible for leading and driving operational and scientific excellence through data standards, and process improvement in CD&A across all Development Units. This includes but is not limited to actively driving updates of clinical processes (process improvement, SOP development) and document templates. The CD&A-AD will also serve as a clinical representative on cross-functional governance boards and development initiatives (including other line function initiatives).

Your responsibilities:

  • Drive the update of clinical documents template such as Clinical Trial Protocol, Informed Consent, Investigator Brochure and Integrated Development Plan according to clinical guidance

  • Participate and represent CD&A on important strategic cross-functional projects as defined by CD&A Leadership Team.

  • Drive cross Development Unit alignment of processes as part of the deliverables of CD&A and drive implementation at the Unit level.

  • QA/SOP activities within CD&A, serve as clinical representative on Process, Training & Governance Board (PTGB) which includes coordinating Subject Matter Experts (SME) identification; applying clinical applicabilities; performing collegial reviews of SOPs and P&SPs.

  • Can serve as a Lead SME or as an SME.

  • Drive best practices by identifying clinical training needs and development opportunities. Identify cross-functional issues, gaps and lead global process improvement work streams as applicable

  • In collaboration with QA, responsible to implement quality initiatives as needed: inspection readiness, records tracking, support audits preparation and follow up.

  • Drive efficiency and track performance against metrics

  • From a people standpoint, work with the CD&A to make sure that CD&A Leadership is informed at all points about key issues and has access to information when needed

Employment Type

Regular


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Associate Director, Clinical Development & Analytics

Novartis Pharmaceuticals