Associate Director Clinical Processes

3 days ago

Dublin, Dublin City, Ireland Healthcare Businesswomen's Association Full time

Job Description Summary

LOCATION: London, UK or Dublin, Ireland
ROLE TYPE: Hybrid Working, #LI-Hybrid

The Associate Director Clinical Processes & Solutions is responsible for leading and driving operational and scientific excellence through clinical process improvement across the portfolio. This includes but is not limited to actively driving updates of standard operating procedures, templates, guidance, and trainings. This position also serves as a clinical representative on cross-functional governance boards and development initiatives (including other line function initiatives).

Job Description

Key Responsibilities:

  • Drive the update of clinical document templates such as Clinical Trial Protocol, Investigator Brochure, Clinical Data Review, and Clinical Development Plan according to clinical guidance.

  • Participate and represent Clinical Development (CD) on important strategic cross-functional projects as defined by CD Leadership Team.

  • Drive cross CD and Global Line Function alignment of processes as part of the deliverables of CD and drive implementation at the Unit level.

  • Lead QA/standard operating procedure (SOP) activities within CD, which includes coordinating Subject Matter Experts (SME) identification; applying clinical applicability; performing collegial reviews of SOPs, templates and processes.

  • Can serve as a Lead SME or as an SME for clinical process-related work such as protocol deviations.

  • 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.

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

Key Performance Indicators:

  • Clinical excellence, sharing of best practices, harmonized across Functions & Divisions.

  • High quality CD processes & successful execution of CD initiatives.

  • Well managed, effective and engaged teams.

Essential Requirements:

Education: Advanced degree in life sciences/ healthcare (or clinically relevant degree) is required. Master, PharmD, or PhD strongly preferred (or equivalent).

Languages: Fluent oral and written English.

Experience/Professional requirement:

  • Strong understanding of Pharmaceutical Development processes.

  • ≥5 years technical and operational experience in planning, executing, reporting and publishing clinical studies in industry or Academia.

  • Thorough knowledge of Good Clinical Practice.

  • Strong scientific background in basic and clinical research.

  • Strong skills in leading and managing cross-functional projects with significant (visible) business impact.

  • Act as change agent and actively generate and foster creativity and innovation in CD.

  • Strong project management skills.

  • Leadership presence with the ability to present and interact with senior management.

Why Novartis?:

Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us Learn more here: https://www.novartis.com/about/strategy/people-and-culture. You'll receive You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.

Commitment to Diversity and Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Join our Novartis Network:

If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.

Skills Desired: Adaptive Strategy And Innovation, Clinical Research, Cross-Functional Teams, Drug Development, Financial Management, Interpersonal Communication Skills, Microsoft Project, Npd (New Product Development), Pmi (Project Management Institute), Pmp (Project Management Professional), Program Management, Project Delivery, Project Execution, Project Life Cycle, Project Planning, R&D (Research And Development), Resource Allocation, Risk Management, Senior Management, Stakeholder Management, Time Management Skills, Waterfall Model.

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