Job ID: REQ-10029778
Date: May 19, 2025
Location: Switzerland
Summary
As the Clinical Development Medical Director in our Immunology Development Unit, you will be responsible for the scientific and clinical strategy of assigned clinical trials, as well as the scientific monitoring and reporting of quality data.
About the Role
The Clinical Development Medical Director (CDMD) for Rheumatology serves as the clinical leader for defined program-level activities, which may include submission activities, briefing books, and large, complex trials, under the guidance of the (Sr.) GPCH. You may lead a section of a clinical program, which could encompass an indication, a new formulation, or a specific development phase.
Key Responsibilities
- Provide clinical leadership and medical strategic input for deliverables associated with the assigned project or program. Deliverables may include sections of individual protocols consistent with the IDP, data reviews, program-specific standards, and clinical components of regulatory documents and publications.
- Drive execution of program sections in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional or country medical associates.
- Oversee or conduct medical and scientific reviews of trial data with Clinical Scientific Experts. You may act as the Program Manager of other associates and function as the study medical monitor.
- Support the SR/GPCH in ensuring the overall safety of the molecule, serving as a core member of the Safety Management Team (SMT) and assisting with program safety reporting.
- Provide medical input into IDP and CTP reviews while contributing to the development of clinical standards for relevant disease areas.
- Support the (Sr.) GPCH or TAH in interactions with external partners, including regulatory authorities, KOLs, and patient advocacy groups, as well as internal partners across various divisions.
- Collaborate with NIBR (Novartis Institute of Biomedical Research) to facilitate the transition of pre-PoC projects to DDP and with BD&L on target identification and due diligence activities.
- Ensure the career development of program reports and clinical colleagues through active participation in performance management and mentoring.
- Contribute to the medical and scientific training of relevant Novartis stakeholders on the disease area and compound/molecule.
- May serve on or lead global initiatives related to process improvement, training, and development of standard operating procedures.
Minimal Requirements
- MD (or equivalent medical degree) is required.
- Medical Board certification preferred. 4+ years of clinical practice experience (including residency) is preferred.
- Possess advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine or subspecialty) is required.
- 5+ years of experience in clinical research or drug development within the pharma/biotech industry, encompassing clinical activities in Phases I through IV.
- 3+ years of contributions to and accomplishments in conducting clinical trials in a global/matrix environment.
- Showcase advanced knowledge of the assigned therapeutic area.
- Demonstrate the ability to establish strong scientific partnerships with key stakeholders.
- Thorough knowledge of GCP, trial design, statistical analysis methodologies, and the regulatory/clinical development process is a must.
- People management experience is preferred, particularly in a matrix environment.
- Exhibit excellent business communication and presentation skills.
- Possess strong interpersonal, negotiation, and conflict resolution skills.
Application Process
We invite you to apply online using the form below. Please note that only applications matching the job profile will be considered.
Why Novartis?
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate individuals collaborating and inspiring one another to achieve breakthroughs that change patients' lives. Are you ready to help create a brighter future together?
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Division: Development
Business Unit: Innovative Medicines
Functional Area: Research & Development
Job Type: Full time
Employment Type: Regular
Location: Hybrid role available in Basel, London, Barcelona, Madrid, or Dublin.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.