Associate Director Clinical Processes & Solutions

Associate Director Clinical Processes & Solutions

Job ID REQ-10042402
Mar 19, 2025
Ireland
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).
About the Role

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
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
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-cultureYou’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.
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
Why Novartis:

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network:

Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:https://talentnetwork.novartis.com/network
IE02 (FCRS = IE002) Novartis Ireland Ltd
Alternative Location 1 London (The Westworks), United Kingdom
Functional Area Research & Development
Job Type Full time
Employment Type Regular
Shift Work No
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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