Senior Medical Director, Early R&I Clinical Development, Rheumatology/Clinical Immunology

Role Summary

Senior Medical Director, Early R&I Clinical Development, Rheumatology/Clinical Immunology. Provide medical and scientific input to preclinical and clinical stage assets focused on Rheumatology/Clinical Immunology, lead cross-functional clinical development activities for early phase studies, and contribute to development plans, study designs, and regulatory documentation.

Responsibilities

• Responsible for the design, delivery and interpretation of clinical studies ensuring the ethical and scientific integrity of the plans, studies and product in compliance with GCP.
• Provide guidance in the medical strategy and clinical/disease expertise to Research, Translational Medicine, Early and Late-stage Clinical Development and Commercial colleagues as part of cross-functional teams.
• Closely follow medical developments within autoimmune/inflammatory diseases and disseminate new information within Clinical Development and the wider organization to transform trends and emerging data into agile and innovative clinical plans.
• Work across early and late R&I clinical development, partner functions and wider AZ organization to ensure design and delivery of clinical development plans with high quality and speed.
• Represent Early R&I Clinical Development to external partners, including Investigators, external experts and patient advocacy groups.
• Medical Lead for regulatory communication and preparation of higher level documents.
• Ensure internal and external peer review of potential study/programme design.
• Support qualification of pharmacodynamic/disease markers for early assessment of efficacy.
• Provide clinical strategic input to in-licensing opportunities as available.

Qualifications

• Advanced degree in Rheumatology/Clinical Immunology (MD or PhD).
• Minimum of 7 years combined industry or relevant clinical or research experience.
• Background in clinical development with experience in Rheumatology or Immunology in a pharmaceutical/biotechnology setting, including design and execution of trials in diseases such as SLE or RA.
• Understanding of the full drug development process, including clinical and non-clinical study design and execution.
• Strong knowledge of clinical research methodology and biostatistics principles to enable innovative and efficient trial design and data-driven decision rules.
• Thorough command of FDA, MHRA and ICH GCP guidelines for global studies.
• Attention to detail, proactive drive to deliver high-quality work, and ability to work with urgency to achieve goals.
• Experience managing complex projects and collaborating with multiple stakeholders to ensure clear communication.
• Proven track record of delivering results and outstanding verbal and written communication skills.
• Excellent analytical, problem solving and strategic planning skills.

Skills

• Medical and scientific input for preclinical and clinical development.
• Cross-functional collaboration and stakeholder management.
• Regulatory strategy and document preparation for clinical programs.
• Clinical trial design, monitoring, and data interpretation in rheumatology/immunology.

Education

• Advanced degree in Rheumatology/Clinical Immunology (MD or PhD).