Clinical Development Medical Director - Immunology

Major accountabilities:

• Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program
• Lead development of clinical sections of trial and program level regulatory documents
• Drive execution of the program and/or clinical trial in partnership with global line functions, assigned Global Trial Directors, and regional/country medical associates
• Support the Global Program Clinical Head in ensuring overall safety of the molecule for the assigned section, and may act as a core member of the Safety Management Team, supporting overall program safety reporting in collaboration with Patient Safety colleagues
• Support the Clinical Development Head by providing medical input into the Clinical Development Plan, Integrated Development Plan and Clinical Trial Protocol reviews. and contributing to development of disease clinical standards for new disease areas
• As a medical specialist, supporting the GPCH or CDH in interactions with external and internal partners and decision boards
• May work with Novartis Biomedical Research/ Translational Medical Sciences to drive transition of pre-PoC projects to DDP and with BD&L including target identification and due diligences together with other medical matters, as needed

Key performance indicators:

• Timely, efficient and quality execution of trials and trial related activities within assigned clinical program(s) within budget, and in compliance with quality standards
• Appropriate funding and resourcing for assigned clinical program(s)
• Adherence to Novartis policy and guidelines and external regulations

Minimum Requirements:

• MD or equivalent medical degree is required, in addition to a proven track record of clinical experience in and scientific contributions to your field of expertise
• Training or working experience in one or more of the following: 1) rheumatology or clinical immunology; 2) lupus clinical trials (systemic lupus erythematous and/or lupus nephritis; 3) B cell-depleting biologics
• 3+ years minimum in clinical research or drug development in immunology/inflammation 
• Working knowledge in the area of Immunology and Inflammation with ability to interpret, discuss and present efficacy (clinical, biomarker) and safety data relating to clinical trials
• Understanding of GCP, clinical trial design, statistics, and regulatory and clinical development processes.
• Availability of, and readiness to leverage scientific and clinical networks to establish scientific partnerships with key collaborators
• Ability to confidently lead independent data monitoring committees and phase 2b/3 advisory boards
   

Skills:

• Budget Management
• Clinical Research
• Clinical Trials
• Coaching
• Cross-Functional Teams
• Lifesciences
• People Management
• Risk Management
• Risk Monitoring

Languages :

• English.