Major accountabilities:

• Supports and if assigned leads delivery of all assigned clinical deliverables in the assigned section of a clinical program. Clinical deliverables may include the clinical development strategy for assigned program section(s), clinical sections of individual protocols consistent with the Integrated Development Plans (IDP), clinical data review and program specific standards, clinical components of regulatory documents/registration dossiers, and publications
• Provides input into final analyses and interpretation including the development of the Clinical Study Report(s) (CSRs), publications and internal/external presentations.
• Leads development of clinical sections of trial and program level regulatory documents (e.g., Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)
• Oversees/conducts ongoing clinical and scientific review of clinical trial data with medical monitor, Clinical Scientific Expert(s) with appropriate oversight from Medical Lead. Work in close collaboration with the data management and statistics teams to ensure proper data quality and analysis of clinical trial results.
• Inspection Readiness and interaction with QA - risk assessments, audit preparation, mock interviews, storyboard and presentation prep; Author and/or review abstracts, presentations and manuscripts for accuracy of clinical data and content
• May be the Program Manager of other associates (e.g., CSE)
• Provides support to Sr CDMD and/or GPCH in monitoring and safety data and signals the molecule for the assigned section of the clinical trial, may be a member of the Safety Management Team (SMT), and supports overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with the medical monitor, CDMD and Patient Safety

This hybrid role can be based in London, Dublin, Basel or Barcelona.

Minimum Requirements:

Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. PharmD, or PhD preferred. Experience in Neuroscience, Cell & Gene, Rare or neuromuscular diseases, and/or Neuroinflammation (preferred).
 

Work Experience:

• ≥ 7 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. ≥ 3 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry
• Advanced knowledge of assigned therapeutic area
• Demonstrated ability to establish strong scientific partnership with key stakeholders
• Thorough knowledge of GCP, clinical trial design and methodology, statistical analysis methodology, and regulatory/clinical development process
• >=1 year of People management experience preferred this may include management in a matrix environment. Global people management experience desirable

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. https://www.novartis.com/careers/benefits-rewards 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

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