Clinical Medical Development Director Immunology
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Overview
The Clinical Development Medical Director (CDMD) for Immunology is the clinical leader responsible for defined program-level activities (e.g., submission activities, briefing books) or a large, complex trial, under the leadership of the (Senior) GPCH. The role may involve leading a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase).
Key Responsibilities
* Provide clinical leadership and strategic medical input for project deliverables, including protocols, data review, regulatory documents, and publications.
* Drive execution of assigned program sections in collaboration with global functions, Trial Directors, and regional medical teams.
* Oversee scientific review of trial data, possibly acting as study medical monitor or program manager for clinical scientific experts.
* Support safety of the molecule, participate in safety management teams, and contribute to safety reporting.
* Assist the Therapeutic Area Head with medical input into reviews and development of disease standards.
* Support interactions with external partners and internal teams, including regulatory authorities, KOLs, and patient groups.
* Work with biomedical research and business development teams to transition projects and identify targets.
* Ensure career development of team members through performance management, training, and mentoring.
* Contribute to scientific training for stakeholders and may serve as a franchise speaker.
* Lead or participate in global initiatives related to process improvement, training, and SOP development.
Minimum Requirements
* MD or equivalent medical degree required; board certification preferred.
* At least 4 years of clinical practice experience preferred.
* Advanced knowledge in a medical/scientific area (e.g., internal medicine).
* Over 5 years of experience in clinical research or drug development, including Phases I-IV.
* At least 3 years of experience conducting clinical trials in a global/matrix environment.
* Strong scientific partnership skills, thorough knowledge of GCP, trial design, and regulatory processes.
Why Join Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives. Join us to be part of a passionate community dedicated to innovation and impact. Learn more about our culture and benefits: Novartis Culture & Strategy.
Benefits
Discover our benefits and rewards in the Novartis Life Handbook. We are committed to diversity and inclusion, fostering an inclusive work environment.
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