The Clinical Development Medical Director (CDMD) is the global clinical leader responsible for defined program activities and deliverables (e.g., submission activities, briefing books), or clinical trials, under the leadership of the GPCH or Sr CDMD.

About the Role

Major accountabilities:

• Provides clinical leadership and strategic medical input for all clinical deliverables in assigned or defined program activities. These may include protocols aligned with the Integrated Development Plans (IDP) and CDP, clinical data review, standards, regulatory documents, and publications.
• Leads the development of clinical sections of regulatory documents such as Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities.
• Drives execution of clinical program sections in collaboration with global line functions, Clinical Trial Heads (CTHs), and regional/country medical associates.
• Provides medical oversight and leadership for trials, potentially acting as medical monitor, and contributes to final analyses, interpretation, and development of Clinical Study Reports (CSRs), publications, and presentations.
• Supports GPCH or Sr CDMD in benefit/risk assessments and safety monitoring, and may be part of the Safety Management Team (SMT). Assists with safety reporting such as PSURs and DSURs.
• May contribute to IDP/CDP and CTP reviews and help develop disease-specific clinical standards.
• Supports interactions with external stakeholders (regulatory authorities, KOLs, advisory boards, patient groups) and internal stakeholders (Research, Medical Affairs, Marketing). May lead or co-chair steering committees.
• Collaborates with Biomedical Research and Business Development to transition pre-PoC projects and conduct target identification and due diligence.
• Ensures career development of team members through performance management, onboarding, training, and mentoring.
• Requires MD or equivalent medical degree, with advanced knowledge in a medical/scientific area (e.g., internal medicine or subspecialty). Medical Board certification is preferred.
• Clinical practice experience of ≥4 years (including residency) is preferred, with experience in Neurology, Cell/Gene, Rare or neuromuscular diseases, or Neuroinflammation highly desirable.

Work Experience:

• ≥5 years in clinical research or drug development, including ≥3 years in all aspects of clinical trials in a global/matrix environment. Late-phase experience is preferred.
• Strong scientific acumen with ability to interpret literature and data.
• Deep knowledge of the therapeutic area and clinical trial methodology, regulatory requirements.
• At least 1 year of people management experience, preferably in a global context.

Why Novartis? Our purpose is to reimagine medicine to improve and extend lives. Join us to be part of this mission. Learn more: https://www.novartis.com/about/strategy/people-and-culture

Commitment to Diversity and Inclusion: We strive to build an inclusive, diverse work environment reflecting the communities we serve.

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Locations: UK, Barcelona, Basel, Dublin.