Job ID
REQ-10029778
Date
May 19, 2025
Location
Switzerland
Summary
As our Clinical Development Medical Director in our Immunology Development Unit, you will spearhead the scientific and clinical strategy of assigned clinical trials while ensuring the quality of data through scientific monitoring and reporting.
About the Role
The Clinical Development Medical Director (CDMD) for Rheumatology assumes the role of clinical leader for defined program-level activities (e.g., submission activities, briefing documents, etc.) or for a large, complex trial, under the guidance of the (Sr.) GPCH. You may also lead sections of a clinical program, which could involve a specific indication, a new formulation, or a particular development phase.
Your Responsibilities
- Provide clinical leadership and medical strategic input for deliverables in the assigned project/program, which may include individual protocols consistent with the IDP, data review, program-specific standards, regulatory documents, and publications.
- Drive execution of the program section in partnership with global line functions, Global Trial Directors (GTDs), and regional/country medical associates.
- Oversee or conduct medical and scientific review of trial data with Clinical Scientific Expert(s) and may function as a study medical monitor.
- Support the (Sr.) GPCH in ensuring the overall safety of the molecule and play a core role in the Safety Management Team (SMT).
- Assist the Therapeutic Area Head (TAH) by providing medical input into IDP and CTP reviews and contribute to the development of clinical standards for the disease area.
- Provide support in external partner interactions, including regulatory authorities, KOLs, patient advocacy groups, and internal partners such as CTT, research, and marketing.
- Collaborate with the Novartis Institute of Biomedical Research (NIBR) to transition pre-PoC projects to DDP and work with Business Development & Licensing (BD&L) on target identification and due diligence.
- Facilitate the career development of program reports and clinical colleagues through participation in performance management and talent planning processes.
- Contribute to medical/scientific training of relevant Novartis stakeholders within the disease area and may serve as a speaker for the franchise.
- May lead or join global initiatives focused on process improvement, training, SOP development, and other Clinical Development initiatives.
Minimal Requirements
- MD (or equivalent medical degree) is required.
- Medical Board certification is preferred, along with 4+ years of clinical practice experience (including residency).
- Advanced knowledge and clinical training in a medical or scientific area (e.g., internal medicine or sub-specialty) is required.
- 5+ years of experience in clinical research or drug development from the pharma/biotech industry, covering clinical activities in Phases I through IV.
- 3+ years of experience in all aspects of conducting clinical trials (planning, executing, reporting, and publishing) in a global/matrix environment.
- Demonstrated knowledge of the assigned therapeutic area and ability to establish strong scientific partnerships with key stakeholders.
- In-depth knowledge of GCP, trial design, statistical analysis methodologies, and regulatory/clinical development processes.
- People management experience is preferred, including experience in a matrix environment. Global people management experience is ideal.
- Excellent business communication, presentation, and interpersonal skills.
- Strong negotiation and conflict resolution capabilities.
Novartis is an equal opportunities employer and welcomes applications from all suitably qualified persons. Apply online using the form below. Only applications matching the job profile will be considered.
Location Flexibility
This hybrid role can be based in Basel, London, Barcelona, Madrid, or Dublin.
Why Novartis?
At Novartis, we believe that helping individuals with diseases and their families requires not just innovative science but also a passionate community. Our collaboration and support for one another lead to breakthroughs that can change patients' lives. Are you ready to help create a brighter future together?
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Benefits and Rewards
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Company Information
Novartis is committed to building an outstanding, inclusive work environment and diverse teams that represent the patients and communities we serve.